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Effects of Pilates exercises on shoulder range of motion, pain, mood and upper extremity function in… Keays, Kimberley Susan 2006

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E F F E C T S O F P I L A T E S E X E R C I S E S O N S H O U L D E R R A N G E O F M O T I O N , P A I N , M O O D A N D U P P E R E X T R E M I T Y F U N C T I O N I N W O M E N L I V I N G W I T H B R E A S T C A N C E R : A P I L O T S T U D Y by Kimberley Susan Keays B . H . K . University o f British Columbia, 1997 A THESIS S U B M I T T E D I N P A R T I A L F U L F I L L M E N T O F T H E R E Q U I R E M E N T S F O R T H E D E G R E E O F M A S T E R O F S C I E N C E in The Faculty o f Graduate Studies (Rehabilitation Sciences) T H E U N I V E R S I T Y O F B R I T I S H C O L U M B I A August 2006 © Kimberley Susan Keays, 2006 A B S T R A C T Effects of Pilates Exercises on Shoulder Range of Motion, Pain, Mood, and Upper Extremity Function in Women Living with Breast Cancer: A Pilot Study Keays, K imber ley S 1 , Harris Susan R 1 , Lucyshyn Joseph M 2 & Maclntyre Donna L 1 'School o f Rehabil itation Sc iences / 2 Department o f Educational and Counsel l ing Psychology and Special Education Universi ty o f Br i t ish Co lumbia , Vancouver, Br i t ish Columbia. Background and Purpose: Our purpose was to examine the effects o f Pilates exercises on shoulder range o f motion ( R O M ) , pain, mood, and upper extremity (UE) function in women who had been treated for breast cancer. Participants: Participants were four women who had undergone axi l lary dissection and radiation therapy for Stage I-III breast cancer. Methods: A non-concurrent, multiple baseline, single subject research design was used to examine the effects o f Pilates exercises on the four outcomes. Results: V isua l analyses o f the data suggest a moderate functional relationship between the implementation o f the Pilates program and improved shoulder abduction and external rotation R O M . Statistically significant improvement in shoulder internal and external rotation on the affected U E was shown for the participant with metastatic disease. The improving baselines seen for pain, mood and U E function data make it impossible to assess Pilates' effects. N o adverse events were experienced. Discussion and Conclusion: Pilates may be an effective, enjoyable and safe exercise option for women recovering from breast cancer treatments; however further research is needed. ii T A B L E O F C O N T E N T S Abstract 1 1 Table o f Contents i ' i L i s t o f Tables v L i s t o f Figures v ' L is t o f Abbreviations : v n Acknowledgements V 1 U Co-Authorship Statement i x Chapter 1 1.1 Introduction 1 1.2 Literature Review 1 1.3 Pilates/Intervention 4 1.4 Study Design 6 1.5 Conceptual Framework for Pilates 7 1.6 Study Aim/Objective 7 1.7 Study Hypothesis 7 1.8 References 8 Chapter 2 2.1 Introduction I 4 2.2 Literature Review I 4 2.3 Study Objective 16 2.4 Methods 1 6 2.5 Repeated Measures 18 2.6 Procedures 20 2.7 Data Analysis 23 2.8 Results 2 4 2.9 Discussion 35 2.10 References 6 2 iii Chapter 3 3.1 Primary findings 65 3.2 Status of relevant working hypotheses 66 3.3 Limitations 68 3.4 Strengths 69 3.5 Metastatic disease 69 3.6 Inter-rater agreement 70 3.7 Adherence 70 3.8 Clinically meaningful change 71 3.9 Social validity 71 3.10 Evaluation of current knowledge 72 3.11 Suggestions for future research 73 3.12 Conclusion 73 3.13 References 74 Appendix 1 Poster used to recruit participants for the study 76 Appendix 2 Participant consent form 77 Appendix 3 Ethics approval form 82 Appendix 4 Brief Pain Inventory (Short Form) 83 Appendix 5 Profile of Mood States (Short Form) 86 Appendix 6 Upper Extremity Function Questionnaire 87 Appendix 7 Social Validity Questionnaire 89 Appendix 8 Pilates Studio Program 91 Appendix 9 Pilates Home Program 92 Appendix 10 Treatment Adherence Guidelines 93 Appendix 11 Treatment Adherence Questionnaire 94 iv LIST OF T A B L E S Table 2.1 Participant background information 43 Table 2.2 Participant treatment information 43 Table 2.3 ITSACORR shoulder range of motion results 44 Table 2.4 Social validity questionnaire: summary of items rated on 10-point Likert scale... .45 Table 2.5 Participant responses to additional social validity questionnaire items 46 v LIST OF FIGURES Figure 2.1 Shoulder flexion: mean level and trend lines for each phase 48 Figure 2.2 Shoulder abduction: mean level and trend lines for each phase 49 Figure 2.3 Shoulder internal rotation: mean level and trend lines for each phase 50 Figure 2.4 Shoulder external rotation: mean level and trend lines for each phase 51 Figure 2.5 Shoulder flexion: baseline trend line extended into intervention 52 Figure 2.6 Shoulder abduction: baseline trend line extended into intervention 53 Figure 2.7 Shoulder internal rotation: baseline trend line extended into intervention 54 Figure 2.8 Shoulder external rotation: baseline trend line extended into intervention 55 Figure 2.9 Brief Pain Inventory: mean level and trend lines for each phase 56 Figure 2.10 Brief Pain Inventory: baseline trend line extended into intervention 57 Figure 2.11 Profile of Mood States: mean level and trend lines for each phase 58 Figure 2.12 Profile of Mood States: baseline trend line extended into intervention 59 Figure 2.13 Upper Extremity Function Questionnaire: mean level and trend lines for each phase 60 Figure 2.14 Upper Extremity Function Questionnaire: baseline trend line extended into intervention 61 LIST OF A B B R E V I A T I O N S QOL Quality of life U E Upper extremity R O M Range of motion SSRD Single subject research design BPI Brief Pain Inventory - Short Form W H O World Health Organization POMS Profile of Mood States UEFQ Upper extremity function questionnaire IT Instructor trainer (for Pilates exercise) Rho (rs) Inter-rater correlation coefficient A C K N O W L E D G E M E N T S I offer my deepest and warmest thanks to Susan Harris for her guidance, support, patience and good humor. I very much look forward to her retirement party! I am also grateful to Donna Maclntyre and Joseph Lucyshyn for their valuable input and encouragement. Thank you to Daniel le McCu l l ough for her assistance with data collection. I appreciate the time that she took out o f her very busy schedule to make it al l happen. Thank you to Heather L o w , o f Mer id ian Pilates, for agreeing to rent her studio space for research purposes. Thank you to Jodie Carre for assisting with the Pilates instruction when I was unable to do it. Thank you to Chr is Petrus for acting as our b l ind rater. Ve ry special thanks to the four wonderful women who participated in the study. They made it al l worthwhi le! A n d to Tom, for putting up with me during al l o f this and for being patient whi le our life plans were put on ho ld . . . for 4 years. Last ly, thank you to the Canadian Breast Cancer Research Al l iance and Novart is Pharmaceuticals Canada for funding the study. v i i i CO-AUTHORSHIP S T A T E M E N T Chapter 1 represents a review of the literature relating to the thesis. It is co-authored with Susan R. Harris, Joseph M . Lucyshyn and Donna L . Maclntyre. M y contributions to this chapter include: -refining the research question and designing the literature search strategy, with the assistance of my co-authors -conducting the literature search and selecting relevant data -synthesizing the findings -preparing the initial draft of the chapter, and incorporating co-author suggestions into subsequent versions Chapter 2 represents a manuscript to be submitted to the journal Physical Therapy, and is co-authored with Susan R. Harris, Joseph M . Lucyshyn and Donna L. Maclntyre. M y contributions to this manuscript include: -coordinating the research design, under the direction of my co-authors -coordinating recruitment and data collection -administering the intervention -preparing the initial draft of the manuscript and incorporating co-author suggestions into subsequent versions I am the primary author and identified as the corresponding author for journal submission for the manuscript presented in chapter 2. Chapter 3 is a summary chapter, and not intended to be a manuscript for submission. ix Chapter 1 1.1 Introduction The goal of rehabilitation is to restore independence and self-sufficiency with a focus on quality of life (QOL),'a multidimensional concept involving physical, psychological, emotional, social and spiritual well-being.2 Functional and emotional well-being are the strongest predictors of overall QOL for women1 and functional Q O L is often the least possessed but most important Q O L dimension underlying overall life satisfaction.3 The diagnosis and treatment of breast cancer can have profoundly negative impacts on quality of life, making rehabilitative interventions that impact physical and psychological functioning, resulting in improved QOL, necessary. Conventional forms of exercise/physical therapy4"19 as well as dance therapy20 have been investigated as interventions to enhance various aspects of QOL in women living with breast cancer, both during and after cancer treatment. Complementary forms of exercise, such as Pilates, yoga and Feldenkrais, have received little research attention as part of cancer rehabilitation. Complementary therapies are those that improve quality of life; address issues of the body, mind and spirit; and help to manage symptoms.21 Up to 80% of women living with breast cancer use complementary and alternative therapies.22 1.2 Literature Review Systematic searches of P U B M E D , M E D L I N E , C A N C E R L I T and C I N A H L (1983-May 2006) revealed no studies involving the effects of Pilates exercise on women living with breast cancer. Keywords used were breast cancer, breast neoplasm, Pilates, radiation, axillary dissection and rehabilitation. Axillary dissection and radiation are common in the management of breast cancer.23 Axillary surgery and irradiation are predictive factors for developing reduced shoulder mobility 2 4" 3 7 in the affected upper extremity (UE). This physical complication has been reported to last up to 11 years after initial treatment.34 In Kwan and colleagues'3 6 survey of women 2-7 years post diagnosis and treatment, 49.9% experienced at least one U E problem, including one or more of the following: arm or hand swelling, shoulder or arm stiffness and lymphedema. At 2 years post surgery, Johansson and colleagues30 found that none of their sample of women (n=96) living with breast cancer had regained pre-treatment shoulder internal rotation range of motion (ROM). Another study found significant restriction of shoulder R O M in 14.1% of women who were 6-96 months post breast conserving therapy or mastectomy, including axillary dissection.32 The mean restriction was 21° for abduction and 12° for flexion, compared to the contralateral shoulder. Sneeuw and colleagues'3 4 study of women 2-11 years post treatment (mean 1 of approximately 4 years) revealed that 14% had a limitation in arm movement that the participants rated as moderate to severe. Voogd et a l 3 8 examined the results of a treatment-specific questionnaire given to women who had axillary dissection an average of 4.2 years prior to the study. Twenty-six percent of patients in the study reported a difference in arm circumference of 2cm or more (which can be indicative of lymphedema), or a difference in shoulder abduction of 20°or more between their affected and unaffected UEs. Voogd et al found that the "differences in arm circumference of 2 cm or more and the limitation of shoulder abduction of 20° or more were strong indicators for the presence of severe physical complaints, limitations in everyday life and psychosocial problems for women who had axillary lymph node dissection for breast cancer."38, p 7 9 Ernst et al 3 9 found a difference of more than 20° in shoulder abduction, extension or flexion in 12% of patients post axillary dissection. Fifty-two percent of the patients studied were 6-12 months post axillary dissection, and 48% had undergone surgery more than five years before the study. Clearly not all women regain full shoulder motion. It has been suggested that post-operative exercise programs could prevent the shoulder stiffness and decreased R O M that often follow axillary surgery and radiation.31 Exercise may also decrease the pain and discomfort associated with fibrosis secondary to treatment.40 Limited evidence suggests that women who have had axillary dissection can safely engage in U E exercise without developing lymphedema. 1 6 ' 4 1 ' 4 2 Patients who have been treated with radiotherapy may benefit from more intensive physiotherapy of longer duration.43 Supervised exercise programs appear to optimize shoulder R O M recovery.37 Chronic pain of variable severity is another common side-effect of axillary dissection 2l-29'32>34'36>39-44-46that can negatively impact mood and Q O L . 4 7 Post treatment pain can persist from 6 months to 8 years after surgery.3 2'4 4 At 1-year post-treatment, 23% 4 5 to 30.4% 2 6 of participants reported intermittent or mild pain. Hladiuk and colleagues27 studied women 18 months post-treatment for breast cancer; 28% reported pain on shoulder movement and 11% of those reported the pain to be moderate or severe. Up to 10% of women have reported pain at rest.28 Sneeuw et a l 3 4 found that 27% of women treated for early stage breast cancer were still experiencing pain, rated as moderate to severe, 2-11 years after treatment. Polinsky 4 8 surveyed women from 16 months to 32 years after their original surgery for breast cancer. Pain in the axilla was reported by 33%, 31% reported pain at the site of the scar and 39% reported pain in the arm. In Kuehn et al 's 3 2 sample of women 6-96 months post treatment, 23% reported permanent pain or disturbed sleep due to pain. The nature, duration and severity of post treatment pain are not yet clearly understood. Pain in subcutaneous tissues, inter-costal muscles or ribs may result from radiation fibrosis.4 0 2 Breast pain may be caused by fibrosis following radiotherapy along with surgical scarring.33 Pain can be the result of inter-costobrachial nerve damage.29 Lymphedema may also cause pain. 4 9 Incisional pain, posterior cervical pain, shoulder girdle pain and muscle spasm in the neck and shoulder region can also occur after treatment.50 Anxiety, depression and anger,4 0'4 8 as well as depreciation of self, somatic distress and poor body image,48 are common psychological sequelae of breast cancer which can also last more than one year following diagnosis. 4 0 ' 4 8 ' 5 1 At times, these sequelae continue despite improvements in physical function.52 Emotional well-being (i.e. mood) is a significant predictor of Q O L . 2 6 The number of axillary lymph nodes dissected has been positively associated with pain and surgery-related pain has been positively associated with emotional distress.53 Exercise can decrease feelings of anxiety,5"7'11 depression,5'54 anger,54 stress,55 and lead to improvements in self-esteem,12'56 self-efficacy,57 vigor 1 2 , 5 8 and satisfaction with life. 5 2 Exercise may also have a cathartic effect.57 Conventional exercise has been shown to be safe and effective for decreasing physical and psychological symptoms and improving Q O L in cancer patients.9*14'15'18"20'57 The type of exercise that has the greatest benefit for minimizing psychological sequelae is not clear. It appears, however, that exercise need not be aerobic to improve mood. 5 4 Compared to women who have not had breast cancer, long-term breast cancer survivors tend to have poorer functional status.59 For women with Stage I-II breast cancer, functional QOL has been shown to have the strongest relationship to overall satisfaction with life.3 Reduced shoulder R O M after axillary surgery and irradiation has been correlated with lack of functional ability. 2 9 At 1-year post treatment, Shimozuma and colleagues26 reported that 22.8% of women had difficulty performing household chores. Post-treatment shoulder stiffness significantly influenced daily activities in 14% of study participants.35 At 18 months after wide local excision and axillary irradiation, Sugden and colleagues29 reported that 24% of participants had difficulty fastening bras, 72% had difficulty doing up a back zipper, 25% had difficulty touching the ipsilateral scapula, 39% had difficulty reaching overhead and 57% had difficulty carrying 5 kg of groceries with the ipsilateral arm. While appropriate exercise can improve U E function,60 there is evidence that supervised exercise may be more effective than self-directed exercise.61 3 1.3 Pilates/Intervention Developed in the early 1900s and originally called "Contrology", Pilates is a mind-body exercise approach based on Eastern theories of body-mind-spirit interaction combined with Western theories of biomechanics, motor learning and core stability.62'65 In this case "spirit" encompasses the whole person, including their emotional well-being. 6 6 Mind-body exercise is physical exercise executed with an inwardly directed, non-judgmental focus and specific attention to breathing and proprioception.67 Although the mind-body interaction of the Pilates approach is perceived as alternative within Western medicine, it is foundational for most Eastern medical practices. Support is growing for use of Eastern exercise, in the form of yoga, 6 8" 7 2 Tai chi 7 2 and Qi Qong 7 3 ' 7 4 in rehabilitation settings. During a Pilates session, intense mental effort is focused on activating specific muscles or muscle groups in a prescribed functional sequence, throughout a full R O M at a controlled speed.75 Quality, precision and control of movement are emphasized. Repetitions rarely exceed 10 and resistance is usually in the form of body weight or springs. Proponents of the Pilates method claim that regular Pilates practice results in relaxation and control of the mind, enhanced body and self-awareness, improved core stability, better coordination, more ideal posture, greater joint R O M , uniform muscle development and decreased stress. 6 2' 6 5' 7 6 Despite the fact that Pilates exercise has been recommended in injury prevention and rehabilitation for ballet,77 groin, 7 8 and foot and ankle7 9 injuries, literature searches reveal a dearth of Pilates studies involving patients. Initially, Pilates research focused primarily on dancers, examining issues of posture and alignment.80"84 For example, Mc Lain et a l 8 0 examined the effects of eight weeks of Reformer (a Pilates machine) instruction on 1) supine jump height and 2) pelvic alignment (while standing and performing jumps) in university dance students (n=14). The experimental group attended 1.5 hours of supervised Reformer workouts per week, as well as 1 hour of unsupervised Reformer workouts per week. The control group (n=10) did not undergo any Reformer instruction. While a significant improvement was found in jump height for each group from pre-test to post-test, there was no significant difference in the amount of improvement between the groups. Pelvic alignment deteriorated for the experimental group and improved for the control group from pre to post test. The researchers concluded that the Reformer protocol used in this study did not improve pelvic alignment while performing a standing jump for university dance students. Self and colleagues81 studied the range of knee motion and the amount of caudally directed force applied by dancers (n=10, all were members of a professional ballet company) during demi-plte movements in first and fifth 4 positions. McMillan et a l 8 2 investigated the effects of Pilates-based exercises on dancers' dynamic posture. Participants were 10 ballet dancers (15-19 years of age) who were divided into experimental (n=5) and control (n=5) groups. The control group did not receive any Pilates-based training. The experimental group attended 23 one-hour, private Pilates sessions over the course of 14 weeks. In addition, they were given a home (mat-based) exercise program to perform daily. When compared to the controls, the participants in the experimental group were found to be more stable in the upper body region while performing a grand pli6 movement. Based on this, the researchers suggested that Pilates-based exercises may improve dynamic body control. More recently, Petrofsky et al 8 5 compared the effects of Pilates exercises performed with a resistive device (the "Zone Pilates Sculpter") to commercial weight lifting equipment in healthy participants (n=6) between 18 and 30 years of age. The researchers were interested in comparing muscle use (based on electromyogram) during both forms of exercise. Their results showed that the Pilates exercises studied yielded minimal muscle activity in the abdominal and paraspinal muscles when compared to exercise on commercial weight lifting equipment; the Pilates exercises performed with the resistive device provided a more efficient workout than the commercial weight lifting equipment because multiple muscle groups were exercised simultaneously; and the Pilates resistive device restricted adverse movement at the joints, making exercise smoother and safer. Herrington and Davies 8 6 evaluated the effects of Pilates exercises and abdominal curls on the ability of asymptomatic participants (n= 36) to contract their transversus abdominis (TrA). The 36 participants were divided into a Pilates exercise group (n=12), an abdominal curl group (n=12) and a control group (n=12). Participants in both the Pilates and abdominal curl groups attended a minimum of 25 classes in the 6 months leading up to the study. The ability to engage the TrA was determined using a Stabilizer pressure biofeedback unit while the participants performed an abdominal hollowing exercise and a lumbo pelvic stability test (both supine). The results suggested that the Pilates-trained participants could contract their transversus abdominis muscle and maintain better lumbo-pelvic control than the participants who performed regular abdominal curl exercises or no abdominal exercises. Segal et a l 8 7 assessed the effects of Pilates training on flexibility, body composition and health status in a sample of 47 adults (45 women, 2 men). Participants attended a one-hour Pilates group mat class at a community athletic club once a week for eight weeks. The researchers concluded that Pilates training may result in improved flexibility (as measured by fingertip to floor distance) but its effects on body composition and health status were 5 more limited and may be difficult to establish. Current knowledge supports principles of core stabilization central to the Pilates approach.88 1.4 Study Design Study aims were evaluated using a non-concurrent, multiple baseline, single subject research design (SSRD). 8 9 SSRD is well suited to rehabilitative settings90 and useful in the early stages of hypothesis generation.91 SSRD is designed to allow the therapist to isolate variables directly contributing to changes in performance.92 Portney & Watkins proposed that single subject research can be the source of "empirical hypotheses that lead to new avenues of study and to the discovery of clinical implications that would not otherwise have been seen or shared". 9 3 p 2 6 2 The underlying principle for single subject evaluation is that no two individuals are alike.9 4 When compared to group research, SSRD is often easier to incorporate into clinical settings and is appropriate for studying small populations. SSRD has been used previously in rehabilitation research.95"97 Many articles are available to the reader interested in a more in-depth exploration of SSRD methodology and its associated strengths and weaknesses. 90,91, 98-105 SSRD is characterized by systematic, repeated measurement of a target behavior through both baseline and intervention phases in which each participant serves as his/her own control.90 This allows comparisons to be made before, during and after an intervention within each participant. At least two independent baselines are required to demonstrate a functional relationship (i.e. an effect) between intervention and behavior change.92 Multiple baseline designs rule out threats to internal validity, including history, maturation, testing effects and regression toward the mean. 8 9 , 1 0 6 Generalizability improves as findings are replicated across subsequent studies with different participants and different researchers. The multiple baseline design is considered one of the strongest SSRD in terms of methodologic rigor and generalizability. 6 1.5 Concep tua l F r a m e w o r k for Pi lates In 1945, Joseph Pilates, founder of the Pilates method, authored a manuscript entitled "Return to Life through Contrology" 7 6 The following passages from this manuscript provided the conceptual framework on which the hypotheses of this study were based: 1) "It (Pilates) was conceived to limber and stretch muscles and ligaments so that your body will be as supple as that of a cat". 7 6 , p J 0 [This statement was assessed as it related to shoulder ROM.] 2) "Contrology develops the body uniformly, corrects wrong postures, restores physical vitality, invigorates the mind and elevates the spirit". 7 6 , p s [This assumption was evaluated as it related to improved mood.] 3) "Contrology exercises build a sturdy body and sound mind fitted to perform every daily task with ease and perfection as well as to provide tremendous reserve energy for sports, recreation and emergencies ". 76'p'10 [This statement was examined as it related to upper extremity function.] 4) " If you faithfully perform your Contrology exercises regularly only 4 times a week for just 3 months... you will find your body development approaching the ideal, accompanied by renewed mental vigor and spiritual enhancement". 76'p6 [This statement provided the parameters for frequency of exercise sessions and length of intervention.] 1.6 S tudy A im /Ob jec t i ve The objective of this pilot study was to examine the effects of Pilates exercise on shoulder R O M , pain, mood and U E function in women who had undergone axillary dissection and radiation therapy for the treatment of Stages I-III breast cancer. 1.7 S tudy Hypothes is We hypothesized that a Pilates exercise program would increase shoulder R O M , decrease pain, enhance mood and improve U E function in women who are at least six months post-treatment for breast cancer. 7 1.8 References 1. 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Cosmetic and functional outcomes of breast conserving treatment for early stage breast cancer. 1. Comparison of patients' ratings, observers' ratings and objective assessment. Radiother Oncol. 1992;25:153-159. 35. Aitken RJ, Gaze M, Rodger A, et al. Arm morbidity within a trial of mastectomy and either nodal sample with selective radiotherapy or axillary clearance. Br J Surg. 1989;76:568-571. 36. Kwan W, Jackson J, Weir L, et al. Chronic arm morbidity after curative breast cancer treatment: prevalence and impact on quality of life. J Clin Oncol. 2002;20:4242-4248. 9 37. Box R, Reul-Hirche H, Bullock-Saxton JE, Furnival C M . Shoulder movement after breast cancer surgery: results of a randomized controlled study of postoperative physiotherapy. Breast Can Res Treat. 2002;75:35-50. 38. Voogd A , Ververs J, Vingerhoets A , et al. Lymphoedema and reduced shoulder function as indicators of quality of life after axillary lymph node dissection for invasive breast cancer. BrJSurg. 2003;90:76-81. 39. Ernst MF, Voogd A C , Balder W, et al. Early and late morbidity associated with axillary levels I-III dissection in breast cancer. J Surg Oncol. 2002;79:151-155. 40. Kiel K, Kopp P. Rehabilitation of breast cancer. In: von Gunten CF, ed. Palliative Care and Rehabilitation of Cancer Patients. Boston: Kluwer Academic Publishers; 1999:107-133. 41. Harris SR, Niesen-Vertommen SL. Challenging the myth of exercise-induced lymphedema following breast cancer: a series of case reports. J Surg Oncol. 2000;74:95-99. 42. Kolden G G , Strauman TJ, Ward A et al. A pilot study of group exercise training (GET) for women with primary breast cancer: Feasibility and health benefits. Psychooncology. 2002; 11:447-456. 43. Blomqvist L, Stark B, Engler N, Malm M. Evaluation of arm and shoulder mobility and strength after modified radical mastectomy and radiotherapy. Acta Oncologica. 2004;43:280-283. 44. Warmuth M A , Bowen G, Prosnitz LR, et al. Complications of axillary lymph node dissection for carcinoma of the breast. Cancer. 1998;83:1362-1368. 45. Tasmuth T, von Smitten K, Kalso E. Pain and other symptoms during the first year after radical and conservative surgery for breast cancer. Br J Cane. 1996;74:2024-2031. 46. Rietman JS, Dijkstra PU, Debreczeni R, et al. Impairments, disabilities and health related quality of life after treatment for breast cancer: a follow-up study 2.7 years after surgery. Disabil Rehabil. 2004;26:78-84. 47. Miaskowski C. Prevalence and morbidity of pain in women with breast cancer. Innov Breast Cancer Care. 1995;1:6-8. 48. Polinsky M L . Functional status of long-term breast cancer survivors: demonstrating chronicity. Health Soc Work. 1994;19:165-173. 49. Rustoen T, Begnum S. Quality of life in women with breast cancer - a review of the literature and implications for nursing practice. Cancer Nursing. 2000;23(6):416-421. 50. Kisner C, Colby L. Therapeutic Exercise: Foundations and Techniques. 3 r d ed. Philadelphia: F.A. Davis Company; 1996. 51. Pinto B M , Trunzo J, Reiss P, Shiu SY. Exercise participation after diagnosis of breast cancer: trends and effects on mood and quality of life. Psychooncology. 2002;11:389-400. 52. Spiegel D. Psychosocial aspects of breast cancer treatment. Sem Oncol. 1997;24(suppl):l-47. 53. Hack T, Cohen L, Katz J, Robson L, Goss P. Physical and psychological morbidity after axillary lymph node dissection for breast cancer. J Clin Oncol. 1999;17:143-149. 54. Berger B, Owen D. Mood alteration with yoga and swimming: aerobic exercise may not be necessary. Percept Motor Skills. 1992;75:1331-1343. 55. Shephard RJ, Shek P. Exercise, immunity and susceptibility to infection. Phys Sportsmed. 1999;27:47-71. 10 56. Baldwin M K , Courneya K. Exercise and self-esteem in breast cancer survivors: an application of the exercise and self-esteem model. J Sport Exerc Psych. 1997;19:334-337. 57. Pinto B M , MaruyamaN. Exercise in the rehabilitation of breast cancer survivors. PsychoOncology. 1999;8:191-206. 58. Pinto B M , Maruyama N, Engebretson TO, Thebarge RW1. Participation in exercise, mood and coping in survivors of early stage breast cancer. J Psych Oncol. 1998;16:45-58. 59. Dorval M, Maunsell E, Deschenes L, Brisson J, Masse B. Long term quality of life after breast cancer: comparison of 8 year survivors with population controls. J Clin One. 1998;16(2):487-494. 60. Wingate L. Efficacy of physical therapy for patients who have undergone mastectomies. Phys Ther. 1985;65:896-900. 61. Na Y M , Lee JS, Park JS, et al. Early rehabilitation program in postmastectomy patients: a prospective clinical trial. YonseiMedJ. 1999;40:1-8. 62. Siler B. The Pilates Body. New York: Broadway Books; 2000. 63. Taylor-Alpers A , Taylor-Segel R. The Everything Pilates Book. Avon, M A : Adams Media Corporation; 2002. 64. Anderson BD, Spector A. Introduction to Pilates-based rehabilitation. Orthop Phys Ther Clin North Am. 2000;9:395-411. 65. Lange C, Unnithan V , Larkam E, Latta P. Maximizing the benefits of Pilates-inspired exercise for learning functional motor skills. J Bodywork Mov Ther. 2000;4:99-108. 66. Latey P. The Pilates method: history and philosophy. J Bodywork Mov Ther. 2001;5:275-282. 67. LaForge R. Mind-body fitness: encouraging prospects for primary and secondary prevention. J Cardiovasc Nurs. 1997;ll(3):53-65. 68. Taylor M, Majundmar M. Incorporating Yoga therapeutics into orthopaedic physical therapy. Orthop Phys Ther Clin North Am. 2000;9:341-359. 69. Monro R. Yoga therapy. J Bodywork Mov Ther. 1997;1(4): 215-218. 70. Chandler K. The emerging field of Yoga therapy. Hawaii MedJ. 2001 ;60:286-287. 71. Janisse M. The therapeutic use of Yoga. Orthop Phys Ther Prac. 2002;14:7-12. 72. Farrell S, Marr Ross A , Sehgal K V . Eastern movement therapies. Comp Ther Phys MedRehabil. 1999;10:617-629. 73. Shang C. Emerging paradigms in mind-body medicine. J Alt Comp Med. 2001;7:83-91. 74. Sancier K M . Medical applications of Qigong. Alternative Ther. 1996;2:40-46. 75. Stone JA. Prevention and Rehabilitation: The Pilates method. Athl Ther Today. 2000;5:56. 76. Pilates J, Miller W. Return to life through contrology. Boston, USA: The Christopher Publishing House; 1945. 77. Khan K, Brown J, Way S, et al. Overuse injuries in classical ballet. Sports Med. 1995;19:341-357. 78. Philips C. Clinical Pilates in the management of groin injuries. J Sci Med Sport. 1999;2:101. 11 79. Cozen D. Use of Pilates in foot and ankle rehabilitation. Sports MedArthros Rev. 2000;8(4):395-403. 80. McLain S, Carter C L , Abel J. The effect of a conditioning and alignment program on measurement of supine jump height and pelvic alignment when using the Current Concepts reformer. J Dance Med. 1997;1:149-154. 81. Self B, Bagley A M , Triplett T L , Paulos L E . Functional biomechanical analysis of the Pilates-based reformer during demi-plie movements. JApp Biomech. 1996;12:326-337. 82. McMillan A , Proteau L, Lebe RM. The effect of Pilates-based training on dancers' dynamic posture. J Dance MedSci. 1998;2:101-107. 83. Parrot A . The effects of Pilates technique and aerobic conditioning on dancers' technique and aesthetic. Kines Med Dance. 1993; 15:45-64. 84. Fitt S, Sturman J, McClain-Smith S. Effects of Pilates-based conditioning on strength, alignment, and range of motion in university ballet and modern dance majors. Kines Med Dance. 1994;16:36-51. 85. Petrofsky JS, Morris A , Bonacci J, et al. Muscle use during exercise: a comparison of conventional weight equipment to Pilates with and without a resistive exercise device. JAppl Res. 2005;5:160-73. 86. Herrington L, Davies R. The influence of Pilates training on the ability to contract the transverse abdominis muscle in asymptomatic individuals. J Bodywork Mov Ther. 2005;9:52-57. 87. Segal N A , Hein J, Basford JR. The effects of Pilates training on flexibility and body composition: an observational study. Arch Phys MedRehabil. 2004;85:1977-81. 88. Richardson C A , Jull G, Hodges PW, Hides JA. Therapeutic Exercise for Spinal Segmental Stabilization in Low Back Pain: Scientific Basis and Clinical Approach. United Kingdom: Churchill Livingstone; 1999. 89. Watson PJ, Workman E. The non-concurrent multiple baseline across-individuals design: an extension of the traditional multiple baseline design. JBehav Ther Exp Psychiatry. 1981;12:257-259. 90. Backman C L , Harris SR, Chisholm JM, Monette AD. Single-subject research in rehabilitation: a review of studies using A B , withdrawal, multiple baseline, and alternating treatment designs. Archives Phys Med Rehabil. 1997;78:1145-1153. 91. Reboussin D M , Morgan T M . Statistical considerations in the use and analysis of single-subject designs. MedSci Sports Exerc. 1996;28:639-644. 92. Ottenbacher KJ. Reliability and accuracy of visually analyzing graphed data from single-subject designs. Am J Occup Ther. 1986;40:464-469. 93. Portney L G , Watkins MP. Foundations of Clinical Research: Applications to Practice. 2nd ed. Upper Saddle River, New Jersey: Prentice Hall Health; 2000. 94. Bates BT. Single-subject methodology: an alternative approach. Med Sci Sports Exerc. 1996;28:631-638. 95. Dumont T L , Maclnytre DL, Harris SR. Effects of a six-week eccentric exercise program on patients with patellar tendinopathy: single-subject research study. Physiother Can. 2006;58:130-147. 96. Kinghorn J, Roberts G. The effect of an inhibitive weight-bearing splint on tone and function: a single-case study. Am J Occup Ther. 1996;50:807-815. 97. Warren S, Yoder P, Gazdag G et al. Facilitating prelinguistic communication skills in young children with developmental delay. J Speech Hear Res. 1993;36:83-97. 12 98. Janosky JE. Use of the single subject design for practice based primary care research. Postgrad Med J. 2005;81:549-551. 99. Onghena P, Edgington ES. Customization of pain treatments: single-case design and analysis. Clin J Pain. 2005;21:56-68. 100. Kinugasa T, Cerin E, Hooper S. Single-subject research designs and data analyses for assessing elite athletes' conditioning. Sports Med 2004;34:1035-1050. 101. Morgan DL, Morgan RK. Single-participant research design. Am Psychol. 2001;56:119-127. 102. Patrick PD, Mozzoni M, Patrick ST. Evidence-based care and the single-subject design. Inf Young Children. 2000;13:60-73. 103. Backman C L , Harris SR. Case studies, single-subject research and N of 1 randomized trials. Am J Phys Med Rehabil. 1999;78:170-176. 104. Bobrovitz CD, Ottenbacher KJ. Comparison of visual inspection and statistical analysis of single-subject data in rehabilitation research. Am J Phys Med Rehabil. 1998;77:94-102. 105. Figoni SF. Single-subject research: bridging the gap between therapy and science. Clin Kinesiol. 1990;44:63-71. 106. Kazdin A E , Kopel SA. On resolving ambiguities of the multiple-baseline design: problems and recommendations. Behav Ther. 1975;6:601-608. 13 C h a p t e r 2 2.1 I N T R O D U C T I O N Rehabilitation aims to restore independence and self-sufficiency while focusing on quality of life (QOL). Functional Q O L is often the least possessed but most important QOL dimension underlying overall life satisfaction.1 Diagnosis and treatment of breast cancer can have profoundly negative impacts on QOL, making rehabilitative interventions that affect physical and psychological functioning important. Rehabilitation researchers have studied the effects of conventional forms of exercise/physical therapy 2 - 8 and dance therapy9 in enhancing Q O L of women living with breast cancer, both during and after treatment. Despite increasing popularity, the complementary form of exercise known as Pilates, has received no research attention as part of breast cancer rehabilitation. Complementary therapies are directed at improving QOL; addressing issues of the body, mind and spirit; and helping to manage symptoms.10 Up to 80% of women living with breast cancer use complementary and alternative therapies.11 2.2 L I T E R A T U R E R E V I E W Systematic searches of PUBMED, MEDLINE, CANCERLIT and CINAHL (1983-May 2006) revealed no studies that had examined the effects of Pilates exercise on women living with breast cancer. Keywords used were breast cancer, breast neoplasm, Pilates, radiation, axillary dissection and rehabilitation. Axillary dissection and radiation are common in the management of breast cancer, and contribute to reduced shoulder mobility 4' 1 2' 1 7 in the affected upper extremity (UE), which can last up to 8 years after initial treatment.13 Post-operative exercise programs may prevent the shoulder stiffness and decreased range of motion (ROM) that often follow axillary surgery and radiation.15 Limited evidence suggests that women who have had axillary dissection can safely engage in U E exercise without developing lymphedema.4'14 Supervised exercise programs appear to optimize shoulder R O M recovery.15 Chronic pain is another common side effect of axillary dissection 1 2' 1 3' 1 6" 1 8 that can negatively impact mood and QOL, and can persist from 6 months to 8 years after surgery.13 The potential causes of post breast cancer treatment pain are many. Pain may result from radiation fibrosis, surgical scarring or inter-costobrachial nerve damage,17 to name a few. 14 Anxiety, depression and anger, as well as poor body image, are common psychological sequelae of breast cancer which can also last more than a year after diagnosis.'8 These sequelae may continue despite improvements in physical function.19 Emotional well-being (i.e. mood) is a significant predictor of Q O L . 1 The number of axillary lymph nodes dissected has been directly related to pain and surgery-related pain has been associated with emotional distress.16 Exercise can decrease feelings of anxiety,5 depression,20 anger,20 and can lead to improved self-esteem,7 self-concept,20 vigor6 and satisfaction with life. 1 9 Conventional exercise has been shown to be safe and effective in decreasing physical and psychological symptoms and improving Q O L in cancer patients.2 - 4'9 Although the type of exercise that is most beneficial in minimizing psychological sequelae is unclear, exercise need not be aerobic to improve mood. 2 0 Long-term breast cancer survivors tend to have poorer functional status than women who have not had breast cancer21 with functional QOL having been shown to have the strongest relationship to overall satisfaction with life.1 Reduced shoulder R O M after axillary surgery and radiation has been correlated with lack of functional ability.17 While appropriate exercise can improve U E function, supervised exercise may be more effective than self-directed exercise.22 Developed in the early 1900s and originally called "Contrology", Pilates is a mind-body exercise approach based on Eastern theories of body-mind-spirit interaction combined with Western theories of biomechanics, motor learning and core stability.23'24 "Spirit" encompasses the whole person, including emotional well-being.25 Mind-body exercise is physical exercise executed with an inwardly directed, non-judgmental focus and specific attention to breathing and proprioception.26 During a Pilates session, mental effort is focused on activating specific muscles in a functional sequence, at controlled speeds. Quality, precision and control of movement are emphasized. Repetitions rarely exceed 10 and resistance is usually in the form of body weight or springs. Proponents of Pilates claim that regular practice results in relaxation and control of the mind, enhanced body and self-awareness, improved core stability, better coordination, more ideal posture, greater joint R O M , uniform muscle development and decreased stress. 2 4 2 7 Studies have examined the effects of Pilates on aspects of dance performance28"32 muscle use 3 3 and flexibility.34 Pilates exercise has been recommended in injury prevention and rehabilitation for ballet,35 groin, 3 6 and foot and ankle3 7 injuries, yet the literature is scant on Pilates studies involving other types of patients. 15 2.3 S T U D Y O B J E C T I V E The objective of this pilot study was to examine the effects of Pilates exercise on shoulder R O M , pain, mood and U E function in women who had undergone axillary dissection and radiation therapy for the treatment of Stage I-III breast cancer. We hypothesized that the Pilates exercise program would increase shoulder R O M , decrease pain, enhance mood and improve U E function in women who are at least six months post-treatment for breast cancer. The data for R O M , level of pain, mood and U E function were not expected to change until a few weeks into the Pilates intervention. We expected that the degree of improvement would vary, based on individual differences. 2.4 M E T H O D S 2.4.1 S tudy Design Study aims were evaluated using a non-concurrent, multiple baseline, single subject research design (SSRD). 3 8 SSRD is well suited to rehabilitative settings39 and useful in early stages of hypothesis generation. SSRD allows the investigator to isolate variables directly contributing to changes in performance.40 The underlying principle for single subject evaluation is that no two individuals are alike. When compared to group research, SSRDs are often easier to incorporate into clinical settings and are appropriate for studying small samples. SSRD is characterized by systematic, repeated measurement of a target behavior through both baseline and intervention phases in which each participant serves as his/her own control,39 allowing comparisons to be made before, during and after an intervention within each participant. At least two separate baselines (i.e. in this case, two separate participants) are required to demonstrate a therapeutic relationship between intervention and behavior change.40 Data were collected across four participants to enhance generalizability. To control for history and maturation, participants entered the intervention phase at staggered intervals.38 Participants were randomly assigned to baselines of 3, 5, 7 or 9 sessions of repeated measures observation.38 Baselines of varying lengths were used to establish the pre-intervention rate of performance and serve as a basis for comparison after intervention was introduced, thus strengthening the evidence that intervention effects were not caused by extraneous variables to which all participants were exposed. 16 Phase changes were made based on shoulder R O M data. Intervention was introduced at the pre-selected time (i.e., after 3, 5, 7 or 9 data collections sessions) if the R O M baselines demonstrated stability.38 If a baseline failed to exhibit stability, it was extended until stability was achieved or until the intervention had to begin for reasons of social validity. To examine the effects of the independent variable on the dependent variables over time (i.e. the "durability" of the intervention effects), follow up data were collected approximately four weeks after completion of the intervention. 2.4.2 Par t i c ipan ts To recruit participants, an article was published in the provincial breast cancer newsletter; posters (Appendix 1) advertising the study were distributed to local cancer support groups and posted in the provincial cancer center and community centers around the city; email messages were sent to local breast cancer dragon boat teams; and announcements were made at local breast cancer forums. Thirty-four women responded to the ads over the course of nine months. Thirteen women could not participate because they did not meet the inclusion criteria and 17 could not participate for "other" reasons (time, location etc). Participants (n = 4) were volunteers who had undergone axillary dissection and completed radiation therapy for Stages I-II1 breast cancer. To be eligible to participate, women had to be at least six months post axillary dissection and radiation therapy for Stages I-III breast cancer and demonstrate restricted shoulder R O M secondary to breast cancer treatment. Restricted ROM was defined as a difference of >10° between the surgical and the non-surgical U E . 1 3 Women who were actively undergoing chemotherapy; had a history of bilateral breast cancer; were attending regular physical therapy, chiropractic, massage therapy or psychological counseling; had previous shoulder injuries or health problems other than cancer and related side-effects were excluded. Demographic data for age, education, marital status, hand dominance, affected side, diagnosis, treatments and current physical activities were collected (Tables 2.1 and 2.2). Signed informed consent (Appendix 2) was acquired from all participants; the study was approved by the Clinical Research Ethics Board at the University of British Columbia (Appendix 3). 17 2.4.3 Setting The Pilates exercise and data collection sessions took place at Meridian Pilates Studio in Vancouver, BC . Meridian Pilates is typical of many community-based Pilates studios in existence today. The home exercise sessions took place in the participants' homes. 2.5 R E P E A T E D M E A S U R E S 2.5.1 Shoulder R O M Shoulder R O M was defined as the range through which the participant could move the shoulder while maintaining a neutral thorax. Measurements were taken with the same plastic, 12-inch universal goniometer while the participant lay supine on a plinth-like platform (a Pilates Cadillac table). Standardized procedures outlined by Clarkson 4 1 were used for all assessments, and the unit of measurement was R O M in degrees. Active shoulder flexion, abduction, internal and external rotation were measured bilaterally. The unaffected U E was measured for comparative purposes. Internal and external rotation measurements were taken with the shoulder in 90° of abduction and a folded hand towel under the humerus. The unaffected (i.e. non-surgical) side was measured first. The rater took three consecutive measurements in each range; the average of the three trials was used as the final score. Higher scores indicate greater ROM. 2.5.2 Level of Pain Pain was assessed using the Brief Pain Inventory Short-Form (BPI),4 2 suitable for evaluating pain over time.1 0 Developed as part of a World Health Organization collaborative project for use with cancer patients, the BPI was designed to provide information on the intensity of pain and the degree to which it interferes with function and various aspects of QOL. The BPI consists of 15 items, including pain drawings (front and back views of a human figure on which the participant is asked to shade the areas of pain) and 7 pain interference questions (e.g. participant is asked to rate how much their pain has interfered with their general activity over the past 24 hours) (Appendix 4). The BPI items are rated on an 11-point scale with lower scores indicating less pain. The test is self-administered, taking approximately 10 minutes to complete and has demonstrated respectable test-retest item correlations over short intervals.42 18 2.5.3 Mood State Mood was assessed using the self-administered Profile of Mood States Scale-Short Form (POMS), 4 3 which rates a variety of mood states (e.g. anxiety, depression, anger, vigor, fatigue, confusion) using a 30-item adjective checklist rated on a 5-point Likert scale (Appendix 5). The score for total mood disturbance is calculated by summing the scores of the 6 POMS factors and then subtracting that score from the Vigor subscale. A lower score indicates less mood disturbance. The short form of the POMS was selected to enhance adherence, given the need for repeated measures in this study. Test-retest reliability estimates range from 0.65 for the Vigor subscale to 0.74 for the Depression subscale.43 Acceptable concurrent validity (/• = 0.80; p <0.01) was demonstrated when the Tension-Anxiety section of the POMS was compared to the Taylor Manifest Anxiety Scale.4 3 2.5.4 Upper Extremity Functioning A 12-item questionnaire was used to assess functional status of the affected U E (Appendix 6). Tasks require a combination of movements through a variety of shoulder ranges and are activities that most women would perform daily. Each item is scored on a 10-point Likert scale from "no difficulty with the task" to "completely unable to do the task". This questionnaire has been used in studies of women living with breast cancer15 and was modified from that used by Wingate8 and designed specifically to assess U E function of women with breast cancer. As suggested by Box et al, 1 5 the scale was expanded from 5 to 10 points to enhance sensitivity. Lower scores indicate improved U E function. 2.5.5 UE Circumference Circumference measures of both UEs, at anatomical landmarks suggested in published clinical practice guidelines,44 were collected weekly to monitor for the potential development of lymphedema. These data served only as a safety guide. If a difference of > 2 cm was noted at any landmark, the participant would have been referred to their oncologist, and to a physical therapist, for in-depth assessments. Although we initially recommended that participants wear compression sleeves on their affected UEs during the Pilates sessions (as a prophylactic measure), none found the sleeves to be comfortable. Al l four participants provided letters signed by their oncologists, stating that they did not have to wear compression sleeves during the Pilates sessions. 19 2.5.6 Soc ia l Va l i d i t y Quest ionnai re At the end of the intervention, a social validity questionnaire (Appendix 7) was given to the participants to assess the acceptability and viability of the Pilates exercise program. The questionnaire was divided into three sections. The first section asked participants to rate the importance of the project goals. The second section asked the participants to rate the acceptability of the strategies used in the study. Responses in sections one and two were rated on a 10-point Likert scale. The third section consisted of five open-ended questions that asked participants to comment on things such as positive and negative effects of the program and whether the Pilates program offered them benefits that other, more conventional forms of exercise, had not. The Likert scale scores were averaged across participants to give an overall social validity rating. The information garnered from this questionnaire will be used to develop community-based Pilates programs for women recovering from breast cancer treatments. 2.6 P R O C E D U R E S 2.6.1 Pi la tes Intervent ion The same certified Pilates instructor conducted most of the Pilates sessions. When the instructor was unable to teach, another certified instructor from the same studio led the participants through their exercise program. Participants attended hour-long exercise sessions, 3X/week for 12weeks (Appendix 8) and were also given a Pilates exercise program to perform at home lX/week for 12 weeks (Appendix 9). Pilates exercises were based on those taught by Stott Pilates.45 Participants began with pre-Pilates exercises and individualized stretches, and progressed to level beginner and, when appropriate, level intermediate exercises. Progression was based on an assessment of the participant's "working level", i.e., the level at which the participant could be safely "in their body", making appropriate neuromuscular connections while still being challenged. Peak Pilates manufactured the equipment used in this study.A A Peak Pilates 5555 Central Ave. - Suite 200 - Boulder, CO 80301 Local: (303) 998-1531 Toll Free: 1-800-925-3674 Fax: 303.473.9142 20 2.6.2 Da ta Co l lec t ion A trained rater collected all baseline and intervention data at the Pilates studio where the intervention took place. Measures were collected in the same order, at the same time of day, on the same day of the week. Data for shoulder R O M were collected 2X/week during baseline and intervention phases. Data for pain, mood and U E function were collected lX/week during both baseline and intervention phases. Follow-up data were collected on the same day of the week and time of day as during baseline and intervention phases. 2.6.3 Inter- rater Agreement A licensed physical therapist trained the raters in this study. During the training session, a woman who had been treated with axillary dissection and radiation for breast cancer served as the person to be measured while the physical therapist guided the two raters through the shoulder R O M measurement procedures outlined by Clarkson. 4 1 The two raters repeated the procedure five more times, without the guidance of the physical therapist, using two different women living with breast cancer as participants (on four occasions) and a woman who had not been treated for breast cancer (on one occasion). The criteria for allowing a rater to conduct experimental measurement were: participation in the physical therapist-led training session; participation in the five additional training measurement sessions; an understanding of the need for, and demonstration of, the systematic, standardized approach to shoulder range of motion measurement. Inter-rater agreement sessions were conducted for 20% of all shoulder R O M data collection sessions, balanced across study phases. To account for lack of rater blinding, a trained outside rater, blind to the phase of the study as well as to the study hypothesis, served as the second rater for inter-rater agreement sessions. Differences of < 7° were considered acceptable inter-rater variability.46 Percent agreement was calculated by dividing the number of agreements by the sum of agreements plus disagreements and multiplying by 100%. Percent agreement for the inter-rater agreement sessions was 74%. Currently, no standards exist as to what constitutes satisfactory inter-rater agreement for active shoulder R O M in women treated for breast cancer. The inter-rater agreement for shoulder R O M in this study was somewhat below the acceptable standard of 80%, despite a standardized measurement protocol and trained raters. This suggests that shoulder R O M in this population may be more variable than in non-patient populations. A study of patients with 21 shoulder dysfunction conducted by Hayes et a l 4 6 supports our findings. Hayes and colleagues investigated inter-rater reliability for shoulder flexion, abduction, and external rotation in patients with rotator cuff repair (n=6), adhesive capsulitis (n=l) and scapulothoracic fusion (n=l). Their inter-rater correlation coefficients (rs) were: flexion = 0.69, abduction = 0.69, external rotation = 0.64. It has been suggested that correlation coefficients from 0.40 - 0.75 equal fair to good reliability.46 Shoulder R O M reliability in women treated for breast cancer needs further study. 2.6.4 Observer Drift The rater and co-investigator periodically reviewed procedures for R O M measurement and questionnaire administration over the course of the study to prevent observer drift. 2.6.5 Treatment Integrity Treatment integrity refers to the degree to which treatments are implemented as intended. To ensure that the Pilates instructor was adhering to the study protocol, a Pilates instructor trainer (IT) monitored one session for each participant. The IT was provided with a sheet outlining the Pilates exercises to be performed. Requirements were that the basic choreography and Pilates principles be adhered to, with flexibility allowed for the images and visualizations used with each participant. In all four cases, the IT confirmed that the Pilates instructor was adhering to protocol. Additionally, the participants could not miss more than 15% (i.e. 5) of the supervised Pilates sessions for the intervention to be considered "complete". No limit was set as to how many home exercise sessions the participants could miss. The instructor standardized and documented the exercises performed during each Pilates exercise session using SOAP notes. The SOAP acronym stands for "Subjective" (what the participant reported that day), "Objective" (what the Pilates instructor noticed during the participant's session), "Action" (which exercises where performed) and "Plan" (what to do in the next session). 22 2.6.6 Treatment Adherence A series of 10 guidelines were followed to promote treatment adherence (Appendix 10).47 In addition, an adherence history questionnaire (Appendix 11) was given to the participants prior to initiating the study. The questionnaire asked about the participants' expectations of the intervention, their goals for the intervention, their perceptions of risks and benefits of the intervention, and life circumstances that might affect adherence. Potential solutions to adherence barriers were discussed prior to initiating the study. 2.7 D A T A A N A L Y S I S Graphed data were visually analyzed using standard rules of evidence for single subject data.40 Levels, trends and variability within and across phases were determined and analyzed for all repeated measures for all participants, and comparison of data paths across participants was made. Level is defined as changes in magnitude of the data, conveyed by changes in the mean level for each phase (i.e. average rate of performance across two or more phases).40 Defined as the direction of change within a phase, an accelerating trend is one that progresses in an upward direction, whereas a decelerating trend progresses downward.40 Trends for all data paths were determined using the Microsoft Excel program ("linear regression" option). To aid in the visual analysis of trend, the baseline trend lines were extended into the intervention and follow up phases. The number of data points above and below the extended trend lines, across the phases, were compared to aid in determining whether or not the intervention had an effect.40 Variability refers to the amount of fluctuation of data points in a series.40 Statistical analysis was conducted using ITSACORR, an interrupted time-series analysis software program.48 ITSACORR uses an omnibus F-test to determine statistical significance of overall change in intercept and slope between baseline and intervention phases with >5 data points and controls for autocorrelation. ITSACORR was selected over the more commonly used C-statistic,49 as there has been some suggestion that the C-statistic fails to maintain an acceptable risk of type I error.50 ITSACORR has been used to assess treatment effects in published SSRD studies.51 ITSACORR analyses were performed only on data sets in which all participants had baseline phases consisting of >5 data points. 23 2.8 RESULTS Throughout presentation of the results, "unaffected" refers to the non-surgical and non-irradiated U E , and "affected" refers to the surgical and irradiated UE. For shoulder ROM, an accelerating trend indicates increasing range and a decelerating trend indicates decreasing range. A decelerating trend for level of pain, mood state and U E functioning indicates improvement. 2.8.1 Visual Analysis 2.8.1.1 Unaffected Shoulder Flexion Range of Motion (Figure 2.1) Participant 1 showed a stable baseline, with an average shoulder flexion range of 142° (range: 138-147 °). Following intervention, a gradual improvement was observed across the 3 months of treatment. R O M increased to an average of 1460 (range: 140-154 °). Shoulder flexion at one month post intervention (144 °) fell below the last data point (153 °) in the intervention phase, and 2° below the mean for the intervention phase. During baseline, Participant 2 showed an accelerating trend (increasing range) with an average shoulder flexion R O M of 168° (range: 165-170°). While the intervention phase showed no trend, R O M increased to an average of 172° (range: 168-174°) across the 3 months of treatment. The one-month follow up data point (170°) fell below the last data point (172°) in the intervention phase, and 2 degrees below the intervention mean. During baseline, Participant 3 demonstrated a decelerating trend (decreasing range) with an average shoulder flexion R O M of 165° (range: 162-168°). While the data path for the intervention phase showed no trend, the average R O M increased to 167° (range: 161-174°). The one-month follow up data point (167°) was the same as both the last data point in the intervention phase and the mean for the intervention phase. Participant 4 showed an unstable baseline with a steep accelerating trend, indicating that R O M was increasing prior to the introduction of the intervention. The average baseline shoulder flexion R O M was 163° (range: 152-171°). During intervention, the data showed less variability and a slightly accelerating trend. The average intervention R O M was 175° (range: 170-181°). The one-month follow up data point (176°) was one degree above the average of the intervention phase (175°), and the same as the last two data points in the intervention phase. 24 2.8.1.2 Affected Shoulder Flexion Range of Motion (Figure 2.1) During baseline, Participant 1 showed a decelerating trend, with an average shoulder flexion range of 127° (range: 123-133°). Following intervention, a gradual improvement was observed across the 3 month treatment. R O M increased to a mean of 137° (range: 130-149°). The one-month follow up data point (142°) was 4° above the last data point (138°) in the intervention phase, and 5° above the mean (137°) for the intervention phase. For Participant 2, the average range of shoulder flexion increased from baseline to intervention. The baseline trend was one of decreasing ROM, with the average range being 150° (range: 146-153°). Over the course of the 3-month intervention, R O M gradually improved to an average level of 154° (range: 143-161°). The one-month follow up data point (158°) was 2° below the last data point (160°) in the intervention phase, and 4° above the mean (154°) for the intervention phase. Participant 3 showed a stable baseline with no trend and an average shoulder flexion range of 154° (range: 153-156°). The intervention data showed a slightly decelerating trend and the average R O M decreased to 153° (range: 147-159°). The one-month follow up data point (154°) was 2° above the last data point (152°) in the intervention phase, and 1° above the mean (153°) for the intervention phase. Participant 4 demonstrated an unstable baseline with a steep accelerating trend and an average R O M of 153° (range: 137-167°). Following intervention, R O M continued to increase, at a less dramatic rate, to an average of 170° (range: 162-174°). The one-month follow up data point (172°) was 2° above the intervention mean, and the same as the last data point in the intervention phase. 2.8.1.3 Unaffected Shoulder Abduction Range of Motion (Figure 2.2) During baseline, Participant 1 showed a decelerating trend with an average range of 115° (range: 111-119°). Following intervention, the average R O M gradually increased to 121° (range: 110-130°). The one-month follow up data point (124°) fell 6° below the last data point during the intervention phase (130°), and 3° above the mean for the intervention phase (121°). During baseline, Participant 2 showed a decelerating trend with an average R O M of 140° (range: 130-160°). A trend of increasing range was seen during intervention. The average shoulder R O M remained unchanged from baseline (140°), but the range varied (132-152°). The one-month follow up data point (144°) was 2° above the last data point (142°) in the intervention phase, and 4 ° above the mean (140°) for the intervention phase. 25 During baseline, the data for Participant 3 exhibited a decelerating trend with an average R O M of 134° (range: 130-145°). During the intervention phase, the data exhibited an accelerating trend and the average R O M increased to 138° (range: 122-146°). The one-month follow up data point (144°) was 6° above the last data point (138°) in the intervention phase, and 6° above the mean (138°) for the intervention phase. During baseline, the data for Participant 4 exhibited a steep accelerating trend. The average baseline R O M was 131° (range: 111-144°). During intervention, R O M continued to increase gradually, reaching an average level of 143° (range: 131-154°). The one-month follow up data point (142°) was 3° below the last data point in the intervention phase (145°), and 1° below the intervention mean (143°). 2.8.1.4 Affected Shoulder Abduction Range of Motion (Figure 2.2) Participant 1 showed a stable baseline with an average shoulder abduction range of 85° (range: 80-89°). Following intervention, a gradual improvement was observed across the 3 months of treatment. R O M increased to an average of 90° (range: 76-105°). The one-month follow up data point (105°) was 5° above the last data point in the intervention phase (100°), and 15° degrees above the mean (90°) for the intervention phase. For Participant 2, the average range of shoulder abduction increased from baseline to intervention. The baseline mean was 92° (range: 86-96°), and the intervention mean was 110° (range: 92-126°). No trend was shown during baseline, and an accelerating trend was demonstrated during intervention. The-one month follow up data point (116°) was 4° below the last data point (120°) in the intervention phase, and 6° above the intervention mean (110°). During baseline, Participant 3 demonstrated a steep decelerating trend, and an average shoulder abduction R O M of 106° (range: 94 -116°). During intervention, the data showed an accelerating trend with an average of 104° (range: 91-117°). The one-month follow up data point (115°) was 2° below the last data point (117°) in the intervention phase, and 11° above the intervention mean (104°). During baseline, Participant 4 demonstrated a steep accelerating trend with an average range of 107° (93-122°). During intervention, the trend continued to accelerate with R O M reaching an average of 131° (range: 113-141°). The one-month follow up data point (132°) was 1° above the intervention mean (131°) and 3° below the last data point in the intervention phase (135°). 26 2.8.1.5 Unaffected Shoulder Internal Rotation Range of Motion (Figure 2.3) During baseline, Participant 1 showed no trend and an average shoulder internal rotation range of 55° (range: 46-61°). During intervention, the average R O M gradually increased to 60° (range: 55-67°) and the data continued to show no trend. The one-month follow up data point (60°) was 5° above the last data point (55°) in the intervention phase, and the same as the mean (60°) for the intervention phase. During baseline, Participant 2 demonstrated a trend toward decreasing range. The baseline average R O M was 67° (range: 64-75°). While the average R O M during intervention (64°, with a range of 57 to 70°) was less than in baseline, the trend changed to one that was accelerating, indicating increasing range. The one-month follow up data point (61°) was 5° below the last data point (66°) in the intervention phase, and 3° above the mean (64°) for the intervention phase. During baseline, Participant 3 demonstrated a decelerating trend with an average shoulder internal rotation R O M of 36° (range: 33-41°). During intervention, the baseline demonstrated an accelerating trend and the average shoulder range increased to 38° (range: 32-42°). The one-month follow up data point (43°) was 3° above the last data point (40°) in the intervention phase, and 5° above the mean (38°) for the intervention phase. During baseline, Participant 4 demonstrated a slightly decelerating trend with an average R O M of 59° (range: 51-65°). During intervention, R O M continued to show a slightly decelerating trend. The average R O M during intervention decreased to 54° (range: 49-60°). The one-month follow up data point (46°) was 8° below the mean of the intervention phase and 6° below the last data point in the intervention phase. 2.8.1.6 Affected Shoulder Internal Rotation Range of Motion (Figure 2.3) For Participant 1, the baseline showed no trend, while the intervention demonstrated a slightly accelerating trend. There was no change in mean level from baseline to intervention (both were 66°), with the intervention phase showing greater range (62-72°) than the baseline phase (63-69°). The one-month follow up data point (67°) was 3° above the last data point (64°) in the intervention phase, and 1 ° above the intervention mean (66°). The average shoulder internal rotation R O M decreased (by 1°) from baseline to intervention for Participant 2. The baseline mean was 56° (range: 52-63°) and the intervention mean was 55° (range: 48-63°). The baseline data demonstrated a decelerating trend. During intervention, an accelerating trend was shown. The one-month follow up (59°) was above the last data point (57°) in the intervention phase, and 4° above the intervention mean (55°). 27 Participant 3 showed a baseline with a decelerating trend, and an average shoulder internal rotation R O M of 44° (range: 40-48°). During the intervention phase, the average R O M decreased to 43° (range: 38-49°), yet the data were stable with a slightly accelerating trend. The one-month follow up (46°) was the same as the last data point (46°) in the intervention phase, and 3° above the intervention mean (43°). During baseline, Participant 4 demonstrated a slightly decelerating trend with an average R O M of 48° (range: 43-56°). While the data exhibited a slightly accelerating trend during intervention, the average R O M decreased to 46° (range: 41-51°). The one-month follow up data point (49°) was 3° above the intervention mean (46°) and 1 ° below the last data point in the intervention phase (50°). 2.8.1.7 Unaffected Shoulder External Rotation Range of Motion (Figure 2.4) Participant 1 demonstrated a baseline with no trend and an average shoulder external rotation of 67° (range: 57-77°). A gradual improvement was seen during the intervention phase, with the intervention mean increasing to 81° (range: 73-94°). The one-month follow up data point (85°) was 2° above the last data point (83°) in the intervention phase, and 4° above the mean (81°) for the intervention phase. During baseline, Participant 2 showed an accelerating trend with an average shoulder external rotation of 92° (range: 85-97°). Although the average R O M increased to 96° (range: 89-102°) during intervention, the trend changed to a decelerating one. The one-month follow up data point (97°) was 5° above the last data point (92°) in the intervention phase, and 1° above the mean (96°) for the intervention phase. Participant 3 showed a trend toward decreasing ROM. The average shoulder external R O M during baseline was 80° (range: 69-101°). During intervention, an accelerating trend was evidenced. The average shoulder external rotation during intervention was 82° (range: 70-93°). The one-month follow up data point (81°) was 8° below the last data point (89°) in the intervention phase, and 1° above the mean (80°) for the intervention phase. Participant 4 exhibited an unstable baseline with no trend and an average R O M of 75° (range: 61-89°). During intervention, the data exhibited an accelerating trend and R O M increased to an average of 93° (range: 71-106°). The one-month follow up data point (99°) was 6° above the intervention mean and 2° below the last data point in the intervention phase. 28 2.8.1.8 Af fected Shoulder E x t e r n a l Rota t ion Range of M o t i o n (F igure 2.4) Participant 1 demonstrated no trend during baseline, with an average shoulder external rotation R O M of 22° (range: 19-26°). Following intervention, a gradual improvement was observed across the 3 month treatment and R O M increased to an average of 40° (range: 25-52°). The one-month follow up data point (53°) was 10° above the last data point (43°) in the intervention phase, and 13° above the intervention mean (40°). For Participant 2, the average shoulder external rotation R O M increased from baseline to intervention. No trend was shown during baseline and the mean R O M was 62° (range: 57-68°). During intervention, an accelerating trend was evidenced with an average R O M of 74° (range: 56-83°). The one-month follow up data point (76°) was 6° below the last data point (82°) in the intervention phase, and 2° above the intervention mean (74°). Participant 3 showed a baseline with an accelerating trend and an average shoulder external rotation R O M of 71° (range: 65-77°). During intervention, an accelerating trend was with an average of 74° (range: 64-86°). The one-month follow up data point (81°) was 5° below the last data point (86°) in the intervention phase, and 7° above the intervention mean (74°). Participant 4 showed an accelerating trend and an average R O M of 67° (range: 55-80°). During intervention, the trend continued to accelerate and the average R O M increased to 90° (range: 72-101°). The one-month follow up data point (97°) was 7° above the intervention mean (90°) and the same as the last data point in the intervention phase. 2.8.1.9 O v e r a l l S u m m a r y of Shoulder Range of M o t i o n Resul ts 2.8.1.9.1 Unaffected U E For the unaffected U E , all four participants experienced an improvement in average level from baseline to intervention for shoulder flexion and external rotation. Participants 1, 3 and 4 improved in level from baseline to intervention for shoulder abduction, and Participants 1 and 3 improved in average level for shoulder internal rotation. The average level did not change from baseline to intervention for Participant 2 in shoulder abduction, and deteriorated for Participants 2 and 4 in shoulder internal rotation. A change in trend, from a stable or deteriorating to an improving trend, was seen in: Participant 1 for shoulder flexion; Participants 1 and 3 for shoulder abduction; Participants 2 and 3 for shoulder internal rotation; and Participants 1, 3 and 4 for shoulder external rotation. Participant 2 showed a change from a deteriorating trend to a stable trend for shoulder abduction. An improving 29 trend in baseline, followed by an improving or stable trend during intervention, was seen for Participants 2 and 4 for shoulder flexion, and Participant 4 for shoulder abduction. For Participants 1 and 3, the majority of the shoulder flexion intervention data points were above the baseline trend lines (Figure 2.5). For Participant 2, almost all of the data points were either below the baseline trend line or on the baseline trend line. All of Participant 4's intervention data points were below the baseline trend line. For shoulder abduction, the majority of the intervention data points for Participants 1, 2 and 3 were above the baseline trend lines (Figure 2.6). All but one of the intervention data points for Participant 4 were below the baseline trend line. For shoulder internal rotation, the majority of the intervention data points for all participants were above the baseline trend lines (Figure 2.7). For shoulder external rotation, the majority of intervention data points were above the baseline trend lines for Participants 1, 3 and 4 (Figure 2.8). For Participant 2, the majority of intervention data points were below the baseline trend line. 2.8.1.9.2 Affected U E All participants improved in average level from baseline to intervention for shoulder external rotation, and Participants 1, 2 and 4 improved in shoulder flexion and abduction. The average level of shoulder flexion (by 1°) and shoulder abduction (by 2 °) deteriorated for Participant 3 from baseline to intervention. None of the participants showed improvement in average level from baseline to intervention for shoulder internal rotation: Participant 1 showed no change; Participants 2 and 3 showed levels that deteriorated by 1°; and Participant 4 showed an average level that deteriorated by 2°. A change in trend, from a stable or deteriorating to an improving trend, was seen in: Participants 1 and 2 for shoulder flexion; Participants 1, 2, and 3 for shoulder abduction; Participants 1, 2, and 3 for shoulder internal rotation; and Participants 1 and 2 for shoulder external rotation. An improving trend in baseline, followed by an improving or stable trend during intervention was seen for Participant 4 in shoulder flexion, abduction and external rotation, as well as Participant 3 for shoulder external rotation. For shoulder flexion, all but one of the intervention data points for Participants 1 and 2 were above the baseline trend lines (Figure 2.5). The majority of intervention data points for Participant 3 and all of the data points for Participant 4 fell below the baseline trend lines. 30 For shoulder abduction, the majority of the intervention data points for Participants 1, 2 and 3 were above the baseline trend lines (Figure 2.6). All of the intervention data points for Participant 4 were below the baseline trend line. For shoulder internal rotation, the majority of the intervention data points for Participants 1, 2 and 3 were above the baseline trend lines (Figure 2.7). For shoulder external rotation, the majority intervention data points were above the baseline trend lines for Participants 1, 2 and 4 (Figure 2.8). For Participant 3, all of the intervention data points were below the baseline trend line. 2.8.1.10 Level of Pain (Figures 2.9 and 2.10) During baseline, Participant 1 showed a decelerating trend, indicating that level of pain was decreasing prior to the introduction of the intervention. The average level of pain for the baseline phase was 22 (range: 2-55). Following intervention, the average level of pain continued to decrease to an average of 11 (range: 0-29). The follow up data point (0) fell below the last data point in the intervention phase (2), and well below the mean (11) for the intervention. The average level of pain increased from baseline to intervention for Participant 2. The baseline phase demonstrated a decelerating trend (indicating a level of pain that was decreasing) and an average score of 4 (range: 2-7). The intervention phase also demonstrated a decelerating trend, although the slope of the trend line was not as steep as in baseline, and the average score increased to 5 (range: 0-18). The one-month follow up data point (3) was the same as the last data point in the intervention phase (3) and 2 points below the mean (5) for the intervention phase. During baseline, Participant 3 showed a decelerating trend, indicating that level of pain was decreasing prior to the introduction of the intervention. The average level of pain score during baseline was 2 (range: 0-5). During intervention, the data exhibited no trend and the average level of pain score decreased to 0 (i.e. all intervention scores were 0). The one-month follow up data point (0) was the same as the last data point in the intervention phase (0) and the mean (0) for the intervention phase. Participant 4 exhibited a decelerating trend during baseline, indicating that level of pain was decreasing prior to the introduction of the intervention. The average level of pain score during baseline was 5 (range: 0-17). 31 During intervention, all data points were 0, indicating that Participant 4 had no pain. No pain was reported at the one-month follow up. At the end of the intervention, the majority of the intervention data points were above the baseline trend lines for all participants. 2.8.1.11 Mood State (Figures 2.11 and 2.12) For Participant 1, the mean level of mood disturbance decreased from baseline to intervention, indicating improvement in overall mood. The baseline mean was 7 (range: -11 to 33), and the intervention mean was -2 (range: -12 to 10). The baseline phase demonstrated a trend of improving mood. This trend continued into the intervention phase, but the slope of the trend line was not as steep as in baseline. The follow up data point (-11) was slightly above (indicating more mood disturbance) the last data point in the intervention phase (-12), but well below (by 9 data points) the intervention mean (-2). For Participant 2, the average level of mood disturbance decreased from baseline to intervention, indicating improvement in overall mood. The baseline phase demonstrated a decelerating trend, with an average mood disturbance score of 0.6 (range: -8 to 5). The intervention phase also demonstrated a decelerating trend, but the slope of the trend line was not as steep as in the baseline. During intervention, the average mood disturbance score decreased to -3 (range: -7 to 3). The one-month follow up data point (2) was above (indicating greater mood disturbance) the last data point in the intervention phase (-7), and above (by 5 data points) the intervention mean (-3). During baseline, Participant 3 reported an average mood disturbance score of -3 (range: -2 to -4). During intervention, the data demonstrated greater variability and an accelerating trend (indicating deteriorating mood). The average mood disturbance score during intervention was -5 (range: -13 to 3). The one-month follow up data point (-13) was below (indicating less mood disturbance) the last data point in the intervention phase (-4), and below (by 8 data points) the intervention mean (-5). Participant 4 showed an improving mood state during baseline. The data showed a decelerating trend with an average score of 14 (range: 5 to 23). During intervention, mood state continued to improve, as evidenced by the decelerating trend and the lower average mood score of 9 (range: -12 to 9). By the one-month follow up data collection session, mood state had deteriorated, reaching a score of 19. 32 For Participants 1, 2 and 4, the majority (all but 2) of the intervention data points were above the baseline trend lines, while all of the data points for Participant 3 were below. 2.8.1.12 Upper Extremity Functioning (Figures 2.13 and 2.14) During baseline, Participant 1 demonstrated a decelerating trend, indicating improving U E functioning prior to the introduction of the Pilates exercise program. The baseline average was 54 (range: 37-63). Following intervention, U E functioning continued to improve, reaching an average of 27 (range: 15-41). At follow up, U E functioning had deteriorated slightly (by 7 points) when compared to the mean of the last 3 data points in the intervention phase (17). For Participant 2, the baseline data exhibited a stable trend, with an average U E functioning score of 24 (range: 21-28). During intervention, the trend changed to one of slightly decreasing function, with an average score of 22 (range: 19-26). The follow up data point (30) was 9° above the last data point in the intervention phase (21) and 1 point above the mean for the intervention phase (22). During baseline, Participant 3 showed a decelerating (improving function) baseline with an average U E functioning score of 25 (range: 23-27). During intervention, the data demonstrated a decelerating trend with an average score of 26 (range: 22-41). The follow up data point (29) was 3 points above both the last data point in the intervention phase (26) and the mean for the intervention phase (26). Participant 4 showed a trend toward improving U E functioning during the baseline phase. The average score during baseline was 16 (range: 11-23). The level of functioning was stable during intervention, showing an average of 12 (range 11-13). At follow up, the level of functioning remained unchanged from that seen during intervention. For Participant 1, all but one of the intervention data points were above the baseline trend line. Approximately half of the intervention data points were above and approximately half were below the baseline trend line for Participant 2. For Participants 3 and 4, all of the intervention data points were above the baseline trend lines. Note: In order to compare the data paths across all four participants, the questionnaire was scored out of 110 instead of 120. The question relating to "zipping up a back fastening dress" was omitted from the data analysis for all participants, due to missing data for Participant 1. 33 2.8.2 Statistical Analysis Shoulder R O M data were analyzed using the ITSACORR program. The results are presented in Table 2.3. Statistical significance was set at p < .05 for all tests. The only analyses that indicated statistically significant change were those for Participant 3's affected U E shoulder internal (p = 0.028) and external rotation (p = 0.049) ROM. Participant 1 approached significant improvement in shoulder abduction (p = 0.123) and external rotation (p = 0.115) on the affected UE . 2.8.3 Treatment Adherence Adherence for the supervised exercise sessions for Participants 1 to 4 was 86%, 89%, 94%, 89%, respectively. To monitor adherence for the home exercise sessions, participants were asked at the beginning of each week during the intervention: "How many of the home program exercises did you complete last week?" Adherence for the home exercise sessions for Participants 1 to 4 was 100%, 100%, 33% and 92%, respectively. 2.8.4 Social Validity Questionnaire Participants were asked to rate questionnaire items on a 10-point Likert scale. The Likert scales ranged from 1 (either: not satisfied, not acceptable or not important, depending on the questionnaire item) to 10 (either: completely satisfied, completely acceptable, very important, depending on the questionnaire item). The average social validity scores across items for participants 1 to 4 were: 8.8/10, 7.2/10, 9.5/10 and 8.6/10 respectively. The average score across participants was 8.6/10. The questionnaire items rated on a Likert scale are summarized in Table 2.4. Participant responses to the social validity questionnaire items that were not rated on a Likert scale are summarized in Table 2.5. 34 2.9 DISCUSSION 2.9.1 Summary of Results 2.9.1.1 Shoulder ROM When all participants and unaffected U E ranges are considered, 13/16 comparisons showed an increase in level from baseline to intervention, and 8/16 comparisons demonstrated improvement in trend (from stable or deteriorating in baseline, to improving during intervention). On the unaffected U E , 7/16 comparisons showed improvement in both average level and trend (from stable or deteriorating to improving) from baseline to intervention. More specifically: Participant 1 showed improvement in both level and trend for shoulder flexion, abduction and external rotation; Participant 3 showed improvement in both level and trend for shoulder abduction, internal rotation and external rotation; and Participant 4 showed improvement in both level and trend for shoulder external rotation. When all participants and affected UE ranges are considered, 10/16 comparisons showed improvement in level from baseline to intervention, and 10/16 exhibited improvement in trend (from stable or deteriorating in baseline, to improving during intervention). On the affected UE, 6/16 comparisons showed improvement in both level and trend: shoulder flexion, abduction and external rotation for Participants 1 and 2. Overall, there was a modest functional relationship between the implementation of the Pilates program and improvement in shoulder external rotation and abduction. Visual analyses suggest that Participant 1 showed the strongest association between implementation of the Pilates intervention and improved shoulder ROM. Average shoulder flexion R O M increased by 4°, abduction by 6°, and external rotation by 14° on the unaffected U E from baseline to intervention. On average, from baseline to intervention, shoulder flexion R O M increased by 10°, abduction by 5° and external rotation by 18° on the affected U E . It is worth noting that Participant 1 was only six months post radiation treatment when she joined the study. Participant 1 was also the oldest (71 years) of the participants; showed the highest overall scores for pain, disturbed mood and difficulty with tasks listed on the U E function questionnaire; and demonstrated the most impaired shoulder R O M on the affected side in flexion, abduction and external rotation when compared to the other three participants, despite the fact that she was the only one of the group that did not have a mastectomy. Participant 1 may also have been the most motivated of the group. From a social validity perspective, Participant 1 rated her satisfaction with the study outcomes as 10/10 (indicating "completely satisfied") and added: "I notice all sorts of 35 changes in my body and really felt the benefit of the exercises, so much that I'll continue with exercises on my own " and "I think that it (the Pilates exercise program) has positive effects beyond the goals of increased mobility and lessened pain in my affected arm/shoulder. I feel my posture is better, I feel taller, my core strengthened, I've lost inches on my thighs and I have more confidence about my ability to commit to a program ". After completing the study, Participant 1 continued with supervised and home Pilates sessions and reported increasing benefit from the exercise program. One month after completing the intervention, Participant 2 was diagnosed with metastatic cancer to the patellae and skull. Given this, it is reasonable to assume that she was living with metastatic cancer while taking part in the Pilates intervention. Even with metastatic cancer, Participant 2 was able to show improvement in both level and trend for shoulder flexion, abduction and external rotation on the affected UE. While Participant 3 was the only participant to show statistically significant change in shoulder R O M for internal and external rotation on the affected U E , visual analysis suggests that, of the participants under study, she may have experienced the least change due to the Pilates program. When compared to the other participants, her changes in level from baseline to intervention across all ranges were the smallest of the sample and, in 3 instances (flexion, abduction and internal rotation on the affected UE), average R O M actually decreased from baseline to intervention. Participant 3 did, however, experience an increase in both level and trend for shoulder abduction, internal rotation and external rotation R O M on the unaffected UE , and scored a 10/10 (indicating "completely satisfied") when asked how satisfied she was with the study outcomes. When asked to comment on the study outcomes, she replied: "I noticed improvedfunction, in terms of greater strength and mobility. I found both the stretching and resistance exercises extremely helpful in improving my range of motion and strength." 2.9.2 Summary of Secondary Dependent Measures 2.9.2.1 Level of Pain Except for Participant 1, the others did not report high levels of pain at the study outset. Participants 1, 3, and 4 demonstrated a decrease in average level of pain from baseline to intervention (decreases of 2-11 points), with Participant 1 showing the greatest decrease (11 points). Level of pain for Participant 2 increased by 1 point from baseline to intervention. The increase in Participant 2's pain scores during the intervention can likely be attributed to what she thought was the aggravation of a longstanding knee injury, but was later diagnosed as patellar metastases. 3 6 The fact that all participants demonstrated trends toward decreasing pain during baseline makes it difficult to conclude that the Pilates exercise program was responsible for the decrease seen in level of pain over the course of the study. 2.9.2.2 Mood State Al l participants showed a decrease in average level of mood disturbance from baseline to intervention. However, the improving mood exhibited by Participants 1, 2 and 4 during baseline makes it difficult to conclude that improvement during intervention was due to the Pilates exercises. The improving mood could have been due to factors unrelated to participation in the study or could have resulted from anticipating positive effects from the upcoming Pilates intervention. At the one-month follow up, Participant 4 showed a dramatic increase in mood disturbance, when compared to the level exhibited during the last part of the intervention phase. She reported feeling "almost a sense of grief at the loss of the regular Pilates sessions. Two factors make one contemplate whether the POMS was the best choice of instrument to measure mood in this study. First, the POMS asked participants to rate various aspects of their mood "during the past week including today" and was completed prior to the Pilates exercise sessions. Participants reported feeling very relaxed and calm after the Pilates sessions, suggesting that the exercise program may have had a transient effect on mood that the POMS was unable to detect. For example, when asked to comment on the effects of the Pilates exercise program, Participant 3 replied: "Pilates was great for my mood -1 really enjoyed the sessions andfelt very relaxed afterwards. " Secondly, one item on the social validity questionnaire asked participants to comment on the instruments used to measure change in the study. Participants 1 and 2 felt that the POMS was insensitive, ineffective and inappropriate as a dependent measure. Although Participants 1 and 2 did not endorse the use of the POMS, the researchers are of the opinion that the effects of Pilates on mood are still worthy of study. Participant 2 provides support for this theory, in her statement that she would recommend the Pilates program to other women living with breast cancer for "both the physical and psychological benefits. " 2.9.2.3 Upper Extremity Functioning While Participants 1, 2, and 4 demonstrated changes in average level from baseline to intervention that were consistent with improving U E functioning, Participants 1 and 4 also exhibited trends indicative of improving 37 function during baseline, making it difficult to conclude that improvement during intervention was due to the Pilates exercises. Participant 3 showed an average level that deteriorated by 1 point from baseline to intervention. This deterioration may be due to the fact that the day on which she reported the most difficulty with U E functioning (the first day of the intervention phase), she was also getting over a bad sinus infection, sore throat, cough and had been bed-ridden for the days leading up to the Pilates session. When her data for day 1 of the intervention phase are ignored, the average level of performance for the baseline phase is the same as for the intervention phase. 2.9.3 Theories as to Why Modest Results Occurred The modest results seen in this study may be due to the Pilates exercise selection and the length of the intervention. The selection of a three month intervention was based the conceptual framework outlined in Joseph Pilates' book "Return to Life Through Contrology", in which he states:" If you faithfully perform your Contrology exercises regularly only 4 times a week for just 3 months... you will find your body development approaching the ideal, accompanied by renewed mental vigor and spiritual enhancement". 2 1 p'6 Because the participants in this study were from a patient population, three of them were over 50 years of age and two of them had metastatic disease, the exercises that Joseph Pilates outlined in his book would not have been appropriate beginning exercises and they were not the exercises selected for the study. It is also possible that the participants in question might have needed more than a three month intervention in order to show dramatic change in R O M . The Pilates program included several exercises that required movement into shoulder abduction and external rotation, which might explain why they were the ranges most affected across participants. Only one of the exercises used in the intervention required notable internal rotation. This, along with postural issues that would likely require more than a three-month exercise intervention to correct, may partially explain why visual analyses suggest that internal rotation R O M appeared to have been less affected by the exercise program. Additionally, the Pilates program was a generic "whole body" program that did not target the U E specifically. An individualized, UE-specific program may have resulted in a more significant improvement in shoulder R O M . It is also possible that the intensity of the Pilates exercise program was too low to elicit statistically significant changes in shoulder ROM. Lastly, the cancer metastases diagnosed in Participant 2 one month after completion of the intervention may explain the lack of improvement seen in her pain and UE functioning scores over the course of the intervention. 38 2.9.4 Contributions to the Literature This study is: 1) the first demonstration of an experimental effect of Pilates on shoulder R O M ; 2) the first documentation of the high social validity of a Pilates intervention; 3) provides documentation of the safety of Pilates exercises for women living with breast cancer, when performed under the direction of a certified Pilates instructor in a community based Pilates studio; 4) provides documentation on the effects of Pilates on multiple measures (ROM, pain, mood and U E function); 5) demonstrates the use of a SSRD that was feasible in a clinical setting (i.e. community based Pilates studio). The results of this pilot study also add to the literature relating to exercise for patients with metastatic breast disease, as two of the participants experienced metastases. Participant 3 was treated with surgery and radiation for metastases to the brain 1.5 years prior to joining the study and, as mentioned earlier, Participant 2 was diagnosed with metastases in both patellae and the skull one month after completing the intervention, and was likely living with metastatic disease while involved in the study. Both women successfully completed the intervention and reported feeling benefit from it. Additionally, Pilates is increasingly sought out as a form of post-rehabilitation exercise for which there is little scientific support. This study will add to the limited data on to Pilates and patient populations. 2.9.5 Implications of the Study / None of the participants experienced any adverse events and none developed lymphedema over the course of the intervention. Results of this study suggest that community-based Pilates programs may be safe options for women living with breast cancer. Physical therapists should encourage interested clients to seek out Pilates instructors who have levels of training consistent with the guidelines established by the Pilates Method Alliance, as well as some knowledge of breast cancer treatments and related cautions. Group Pilates classes are not an appropriate starting point for anyone from a patient population. Women living with breast cancer should begin with private Pilates sessions, in order to ensure that they are performing the exercises safely, and work their way up to joining group classes. When discussing post-rehabilitation exercise options with breast cancer clients, it is important for physical therapists should be aware that Pilates is unlikely to have an aerobic conditioning effect, and should serve as an adjunct to aerobic exercise. Because of its low intensity nature and its focus on neuromuscular repatterning, Pilates would be a sensible starting point from which women could gradually return to their regular activities after breast cancer treatments. 39 Rehabilitation interventions of any kind are unlikely to have an impact on impairments if they are not important, viable and acceptable to the consumer. The participants in this study stated that they would recommend the Pilates program to other women living with breast cancer, indicating that they found the program acceptable. Pilates exercise may benefit women living with breast cancer in a variety of ways that were not examined in this pilot study. For example, when asked if the exercise program had positive or negative effects beyond what had been measured, Participant 4 responded: "/ learned so much. Breathing deeply was wonderful. I learned to overcome my fear, trust my body and movement. I was shocked at how much I could do after a month or so. I feel connected to my body in a way I never did before. I think the numb areas from surgery have felt more connected - almost sensation returned. " When compared to conventional exercise, Pilates may provide different benefits. When asked what the Pilates exercise program offered that other, more conventional forms of exercise did not, Participant 2 answered: "To realize that 'doing it right' is better, more subtle and more challenging than the 'no pain, no gain' thesis. To experience such an infinite variety of ways of moving and thinking was wonderful. " Although the participants in this study found the intervention to be acceptable, it is unlikely that at an average rate of $50-75/hour, many women could afford to attend one-on-one Pilates sessions three times a week for three months, as was the case in this study. In terms of study design, a concurrent multiple baseline would have been a stronger choice, as there has been some suggestion that the non-concurrent multiple baseline SSRD used in this study does not control for history as a threat to internal validity. The non-concurrent multiple baseline was selected because: it was not known whether the Pilates intervention would have any effect on the primary dependent measure, shoulder R O M ; if shoulder R O M did show change after the implementation of the intervention, it was expected to happen gradually, resulting in participants having to remain in baseline for lengthy periods of time; and it was important to complete the study in a time frame befitting a master's thesis. A longer follow up period would have allowed the researchers to determine how long the improved R O M (where applicable) would last in the absence of a thrice-weekly, supervised Pilates program. 40 2.9.6 Limitations There are several limitations to this study. Testing effects may have threatened internal validity, as evidenced by improving R O M during several of the baselines. The baseline data that showed trends consistent with improving ROM, pain, mood or function make it difficult to effectively assess the intervention's effects. Based on these pilot data, it would appear that three baseline data collection sessions are not sufficient to establish "stable" R O M data for shoulder flexion, abduction, internal and external rotation. The fact that the baseline phases had to be extended for two participants (1 and 4) lacked social validity, as the participants were anxious to begin the intervention and found the data collection sessions tedious and boring. Because the rater worked at the Pilates studio where the intervention took place, it was impossible to keep her blind to the study hypothesis, or to the study phase. We accounted for this limitation, however, by using a blind outside rater for inter-rater agreement sessions. Although this was intended to be a pilot study, the small number of participants limits generalizability. Finally, it may be difficult to measure the exercise dose, as it may have differed slightly from participant to participant for a variety of reasons, i.e. the time required to explain and refine the exercises depended on the individual, participants' energy levels differed (e.g. Participant 3 attended the Pilates sessions after lunch, a time of day when she reported feeling the most "sleepy"), actual time spent exercising per session may have differed (e.g. Participant 3 often started late and had to leave early), and adherence to the home exercise program differed (e.g. Participants 2 and 3 did not complete all the home exercise sessions). In cases where participants did experience improvement in shoulder R O M , it was impossible to determine whether it was due to the Pilates program on the whole, or to specific exercises in the program. 2.9.7 Suggestions for Future Research Larger studies that compare Pilates exercises to conventional weight training or physical therapy exercise programs would be worth studying, as would studies that involve interventions of longer duration and the more sensitive outcome measures. Because breast cancer treatments are individualized and few women receive exactly the same treatments, individualized Pilates programs could be compared to the generic Pilates program given to the participants in this study. Group Pilates classes could also be compared to one-on-one Pilates sessions to help understand the associated costs and benefits of each. Additionally, as there are no standard definitions of what constitutes "reduced shoulder mobility" or "acceptable inter-rater and intra-rater shoulder R O M reliability" after breast 41 cancer treatments, research aimed at developing such definitions would be of value. Standard definitions would allow for more accurate comparisons of study results. 2.9.8 Conclusion Not every woman who undergoes treatment for breast cancer will develop impaired shoulder R O M but, for those who do, appropriate interventions are necessary. Most of the reduction in shoulder mobility may develop within the first two years after treatment, making early identification of women prone to developing this impairment important. More people are engaging in Pilates as a form of post-rehabilitation exercise therapy, yet few patient-based studies have been conducted. Data suggest that the Pilates program, had a modest effect on shoulder abduction and external rotation. The participants in this pilot study perceived the Pilates exercise to be enjoyable and the program beneficial and did not experience any adverse events. While further study is needed, preliminary data suggest that Pilates could be an effective, enjoyable and safe and exercise option for women after breast cancer treatments. 42 Table 2.1 Participant Background Information Participant Age Highest Level of Education Completed Marital Status Dominant Arm/Hand Other Activities - Current 1 71 University Widowed Right Walking 2 66 University Married Right Walking 3 38 University Married Right Walking/Running 4 51 University Divorced Right Walking/Running Table 2.2 Participant Treatment Information Participant Diagnosis Year of Diagnosis Stage Affected Side # Nodes Dissected # Nodes Involved Surgery Radiation 1 Invasive ductal carcinoma 2002 III Left 17 0 Lumpectomy (L)breast 2 Invasive ductal carcinoma 2002 II Right 18 2 Complete right breast mastectomy (R)mid-axilla 3 Invasive ductal carcinoma 2001 III Left 6 6 Bilateral mastectomy (L)chest wall 4 Invasive lobular carcinoma 2003 I Left 16 0 Bilateral mastectomy, reconstruction (tissue expander, silicone implants) (L)chest wall 43 Table 2.3 ITSACORR Shoulder Range of Motion Results Participant UNAFFECTED A F F E C T E D 1 Flexion F(2, 24) = 0.050 P = 0.951 Flexion F(2, 24) = 2.041 P = 0.152 Abduction F(2, 24) = 1.234 P = 0.309 Abduction F(2, 24) = 2.287 P = 0.123 Int. Rotation F(2, 24) = 0.864 P = 0.434 Int. Rotation F(2, 24) = 0.266 P = 0.769 Ext. Rotation F(2, 24) = 1.011 P = 0.379 Ext. Rotation F(2, 24) = 2.369 P = 0.115 2 Flexion F(2, 26) = 1.909 P = 0.169 Flexion F(2, 26) = 0.256 P = 0.776 Abduction F(2, 26) = 0.872 P = 0.430 Abduction F(2, 26) = 1.712 P = 0.200 Int. Rotation F(2, 26) = 1.499 P = 0.242 Int. Rotation F(2, 26) = 0.227 P = 0.799 Ext. Rotation F(2, 26) = 1.584 P = 0.224 Ext. Rotation F(2, 26) = 1.317 P = 0.285 3 Flexion F(2, 20) = 1.204 P = 0.321 Flexion F(2, 20) = 0.056 P = 0.946 Abduction F(2, 20) = 0.459 P = 0.638 Abduction F(2, 20) = 1.048 P = 0.369 Int. Rotation F(2, 20) = 0.504 P = 0.612 Int. Rotation F(2, 20) = 4.277 P = 0.028 Ext. Rotation F(2, 20) = 0.450 P = 0.644 Ext. Rotation F(2, 20) = 3.519 P = 0.049 4 Flexion F(2, 24) = 0.555 P = 0.581 Flexion F(2, 24) = 1.188 P = 0.322 Abduction F(2, 24) = 1.482 P = 0.247 Abduction F(2, 24) = 0.707 P = 0.503 Int. Rotation F(2, 24) = 0.028 P = 0.972 Int. Rotation F(2, 23) = 1.189 P = 0.323 Ext. Rotation F(2, 24) = 1.360 P = 0.276 Ext. Rotation F(2, 23) = 0.436 P = 0.652 Note: "Int. Rotation" = internal rotation, "Ext. Rotation" = external rotation 44 Table 2.4 Social Validity Questionnaire: Summary of Items Rated on 10-point Likert Scale Participant / 2 3 4 How important are the following project goals to you: Improved shoulder R O M 8 8 10 10 Decreased level of pain 9 4 10 3 Improved mood state 8 4 7 10 Improved upper extremity functioning 8 8 10 10 Strategies Used How satisfied are you with the Pilates exercise program 10 10 10 10 Study Outcomes How satisfied are you with study outcomes 10 9 10 10 Total social validity rating (/60) 53 43 57 53 Note: For the project goals section of the questionnaire, the scale ranged from 1 (not important) to 10 (very important). For the strategies used section of the questionnaire, the scale ranged from 1 (not acceptable) to 10 (completely acceptable). For the study outcomes section of the questionnaire, the scale ranged from 1 (not satisfied) to 10 (completely satisfied). 45 Table 2.5 Participant Responses to Additional Social Validity Questionnaire Items Social Validity Questionnaire Item Participant 1 Participant 2 Participant 3 Participant 4 In your opinion, were the instruments used to measure change in this study sensitive, effective and appropriate? All but the POMS - a client's mood is subject to many intervening factors. I found the questionnaires boring and repetitive. Improved mood and decreased pain are hard to quantify and fluctuations are likely caused by factors outside of this study. I thought the POMS was a bit silly - there are too many options. For example, what is the difference between "full of pep", "energetic" and "lively"? Yes Did this exercise program have positive or negative effects beyond what has been measured? If so, please list them. Yes, I think that it has positive effects beyond the goals of increased mobility and lessened pain in my affected arm/shoulder. I feel my posture is better, I feel taller, my core strengthened, I've lost inches on my thighs and I have more confidence about my ability to commit to a program. Positive: the interaction with the researchers, the feeling of personal warmth and connection was the best aspect of the program. Getting to learn how to reprogram my mind as well as my body was fascinating -1 hope it lasts a long time. NA I learned so much! Breathing deeply was wonderful. I learned to overcome my fear, trust my body and movement. I was shocked at how much I could do after a month or so. I feel connected to my body in a way I never did before. What, if anything, did this Pilates exercise program offer you that other, more conventional forms of exercise, have not? 1) a focus on a weak area 2) a structure that was consistently guided 3) a chance to try a new way of exercising 4) improved posture and a strengthened core 5) improved balance and flexibility in toes and ankles To realize that "doing it right" is better, more subtle and more challenging than the "no pain, no gain" thesis. To experience such an infinite variety of ways of moving and thinking was wonderful. 1) stretches and exercises that were tailored perfectly to my needs 2) felt secure knowing that the instructor was ensuring that I performed each exercise in a safe and correct manner - other exercise programs focus less on anatomically correct movement Focus, relaxation, balance, connection -at a very deep level I was able to feel my body. It felt like I was light, flexible, limber - like the Tin Man after he got oil. 4 6 Table 2.5 (Continued) Participant Responses to Additional Social Validity Questionnaire Items Social Validity Questionnaire Item Participant 1 Participant 2 Participant 3 Participant 4 What did you enjoy the most about this exercise program? What was the most significant benefit? 1) the consistent one-on-one sessions 2) liked having a chance to voice my concerns and being asked how I was doing and listened to before every session N A 1) the many stretching exercises 2) instructor's touch and explanations were fantastic and allowed me to get full benefits of each exercise Poise, posture, confidence, peace. It really expanded my mind as far as what is possible. I'm so proud of myself and so grateful for the opportunity to enjoy my body again. What did you enjoy the least about this exercise program? It took a long time and a lot of patience before I could see any real benefits. Trying to make the home exercise segment as rewarding as the studio sessions. Having someone watch and cue you is great - I'll have to learn to do that now for myself. The frequency of the exercise sessions - it was difficult at times to fit in 3 sessions a week. I feel like I need to say something, so I'll say "parking" -mostly because I was so thrilled with all of it. Would you recommend a Pilates exercise program to other women who have limited shoulder range of motion secondary to breast cancer treatments? Why or why not? Yes, I would, but I would explain two things: 1) they would need to be patient 2) the improvement might not be as dramatic as they would hope for...but I would assure them that if they worked at it they would be happy with the results. Yes, definitely, for both the physical and psychological benefits. Yes - for the reasons already mentioned and because the program has given me a good understanding of how my bones and muscles work, and how to do activities to maintain my strength and mobility. Absolutely. I think I would serve many rehab situations also. 47 Baseline Intervention Follow-[Participants j • 'A * 11 2 3 4 5 6 7 8 9 10 11 12 13 14 15 18 17 18 1B 20 21.22 23 24 25 26 27 28 29 30 ! Measurement Probes (bi-weekly) Follow-up |Participant HM | 2 3 4 5 8 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 28 27 28 29 30 31 32 33 34 35 36 37 38 39 40 Measurement Probes (bi-weekly) Baseline Intervention Follow-up (Participant #2 | • A 2 3 4 5 8 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 28 27 28 29 30 31 32 33 34 35 38 37 38 Measurement Probes (bi-weekly) Baseline Intervention Follow-up {Participant #41 • A / 2 3 4 5 6 7 10 11 12 13 14 15 16 17 1B 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 3 Measurement Probes (bi-weekly) Trend line _ _ L e v e l : unaffected U E ' L e v e l : affected U E • Unaffected U E Affected U E Figure 2.1 Shoulder flexion: mean level lines and trend lines for each phase. The figures above are organized from shortest to longest baseline for ease o f interpretation. 48 Follow-up [Par t ic ipant« 10 11 12 13 14 15 18 17 18 19 20 21 22 23 24 25 26 27 26 29 30 31 Measurement Probes (bi-weekly) o Intervention Follow-up |Participant#1 | • 1 2 3 4 5 6 7 8 9 1 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 20 27 2S 29 30 31 32 33 34 35 36 37 38 39 40 Measurement Probes (bi-weekly) Baseline Intervention Follow-up |Particlpant#2| • 'it I 3 A 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 Measurement Probes (bi-weekly) n [Participant JMJ 2 3 4 5 6 7 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 Measurement Probes (bi-weekly) ——— T r e n d l ine _ _ L e v e l : u n a f f e c t e d U E L e v e l : a f f e c t e d U E • U n a f f e c t e d U E A A f f e c t e d U E Figure 2.2 S h o u l d e r a b d u c t i o n : m e a n l e v e l l ines a n d t rend l ines for e a c h p h a s e . T h e f igures a b o v e are o r g a n i z e d f r o m shortest to l onges t base l ine f o r ease o f i n t e r p r e t a t i o n . 49 Follow-up iParticlpant Ja\ 2 3 4 J 6 7 8 9 10 11 12 13 14 1S 16 17 18 18 20 21 22 23 34 25 28 27 28 29 30 : Measurement Probes (bi-weekly) I I f " Baseline Intervention Follow-up [Participant «1 I • 1 2 3 4 5 8 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 28 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 Measurement Probes (bi-weekly) Baseline Intervention Follow-up [Participant « 1 f 1 WJf ! » 1 1 "y* *' — — — ™ m 2 3 4 5 8 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 Measurement Probes (bi-weekly) Baseline Intervention Follow-up (Participant #4 • 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 18 17 18 19 20 21 22 23 24 25 26 27 28 29 31 Measurement Probes (bi-weekly) 31 32 3 34 35 36 Trend line . — — Level: unaffected U E • Level: affected U E • Unaffected U E Affected U E Figure 2.3 Shoulder internal rotation: mean level lines and trend lines for each phase. The figures above are organized from shortest to longest baseline for ease of interpretation. 50 180 I " Follow-up I Participant #3] 2 3 4 5 6 7 8 9 1Q 11 12 13 14 15 16 17 18 19 20 21 22 23 24 28 28 27 28 29 30 31 Measurement Probe* (bi-weekly) I f Baselin Intervention Follow-up | Participant #1 I • * ••—-^ • m m m m m m - Trend line _ Level: unaffected U E ' Level: affected U E • Unaffected U E Affected U E 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 26 29 30 31 32 33 34 35 36 37 38 39 4! Measurement Probes (bi-weekly) | 8 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 2B 29 30 31 32 33 34 35 36 37 38 Measurement Probes (bi-weekly) 110 30 20 10 i—•—•—•—•—i—• 1—i—.—!—.—i—i—i—i—i—i—i—.—i ,—,—, ,—,—,—,—, ,—,—,—i 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 Measurement Probes (bi-weekly) Figure 2.4 Shoulder external rotation: mean level lines and trend lines for each phase. The figures above are organized from shortest to longest baseline for ease of interpretation. 51 Baseline Intervention ^ ^ ^ ^ Follow-up [Participant #3 • ft 9 10 11 12 13 14 15 16 17 16 19 20 21 22 23 24 25 26 27 28 26 30 31 Measurement Probes (bi-weekly) f Baseline \ . t Intervention Follow-up |Participant#1 I V v ' V * * * *, V H A-%\ •: i t * * ' k t 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 1 8 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 Measurement Probes (bi-weekly) Baseline Intervention Follow-up |Participant« | 1 a *-•*-_ -A M * • * ^^^^^^ A * ' * ' * V 2 3 4 5 6 7 8 9 10 11 12 13 14 15 18 17 18 19 20 21 22 23 24 25 28 27 28 29 30 31 32 33 34 35 36 37 38 Measurement Probes (bi-weekly) Baseline Intervention Follow-up | Participant #4 • * ,' A * 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 Measurement Probes (bi-weekly) • Unaffected U E Affected U E ~ ~ Baseline trend line Figure 2.5 Shoulder flexion: baseline trend line extended into intervention and follow up. The figures above are organized from shortest to longest baseline for ease of interpretation. 52 I Baseline Intervention Follow-up |ParticipanI »3 | • \ V ii. 2 3 4 5 8 7 • Unaffected U E Affected U E — ~ Baseline trend line 10 11 12 13 14 15 16 17 18 16 20 21 22 23 24 25 26 27 28 29 30 31 Measurement Probes (bi-weekly) | 110 ra Baseline Intervention Follow-up (Participant #1 | * * 2 3 4 3 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 Measurement Probes (bi-weekly) Baseline Intervention Follow-up (Participant #2 ( • A • \ 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 28 27 28 29 30 31 Measurement Probes (bi-weekly) )  3 4 35 38 37 38 Baseline Intervention j ^ ^ ? 1 ^ Follow-up (Participant #4 | * *• / a,-A. * • \ A * * 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 16 19 20 21 22 23 24 25 26 27 28 29 3t Measurement Probes (bi-weekly) 31 32 33 34 35 36 Figure 2.6 Shoulder abduction: baseline trend line extended into intervention and follow up. The figures above are organized from shortest to longest baseline for ease of interpretation. 53 180 Baseline Intervention Follow-up (Participant #3 • 2 3 * 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 16 29 30 31 Measurement Probes (bi-weekly) Baseline Intervention Follow-up | Participant #1 | • V 1 2 3 4 5 6 7 8 9 10 11 12 13 14 1 5 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 Measurement Probes (bi-weekly) Follow-up P a r t i c i p a n t « 2 3 4 5 6 7 B 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 2' 28 29 30 31 32 33 34 35 36 37 38 Measurement Probes (bi-weekly) I • I -Intervention Follow-up (Participant #4 | ' B . 2 3 4 5 6 7 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 2B 29 X 31 32 33 34 35 3 Measurement Probes (bi-weekly) • Unaffected U E Affected U E ~ ~ " Baseline trend line Figure 2.7 Shoulder internal rotation: baseline trend line extended into intervention and follow up. The figures above are organized from shortest to longest baseline for ease of interpretation. 54 Baseline Intervention Follow-up (Participant #3| 2 3 4 5 6 7 8 9 10 11 12 13 14 IS 18 17 18 19 20 21 22 23 24 23 28 27 28 29 30 31 Measurement Probes (bi-weekly) I-I-i = so i "5 50 Baselin Intervention Follow-up I Participant «1 I • w v / \ * A A ,4 X \ » t * * * — * * 2 3 4 5 8 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 38 37 38 39 40 Measurement Probes (bi-weekly) I Baseline IlllllliHllllillll Follow-up 4 ii. A _'* > i | Participant #2 | 7 8 9 10 11 12 13 14 15 18 17 18 19 20 21 22 23 24 25 26 27 2B 29 30 31 32 33 34 35 36 37 38 Measurement Probes (bi-weekly) Baseline ^ ^ n t o ^ F o l l o w - u p ^ [ Participant #4 | S 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 Measurement Probes (bi-weekly) • Unaffected U E Affected U E — ~ Baseline trend line Figure 2.8 Shoulder external rotation: baseline trend line extended into intervention and follow up. The figures above are organized from shortest to longest baseline for ease of interpretation. 5 5 Follow-up | Participant #3 | • BPI Score . _ Level — Trend 20 21 22 — 40 Baseline Intervention Follow-up | Participant #1 | 2 3 4 5 8 6 S 10 11 12 13 14 15 16 17 18 19 20 21 Measurement Probes (weekly) — 40 £ 2 3 4 5 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Measurement Probes (weekly) | ParticipantiTj 2 3 4 5 9 1 0 11 12 13 14 15 16 17 18 1 9 20 21 22 23 24 25 Measurement Probes (weekly) Figure 2.9 Brief Pain Inventory: mean level lines and trend lines for each phase. The figures above are organized from shortest to longest baseline for ease of interpretation. Follow-up {Participant #3 | 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Measurement Probes (weekly) [ Participant tT") Measurement Probes (weekly) Baseline Intervention Follow-up | Participant #2 | • 2 3 4 5 6 9 10 11 12 13 14 15 16 < Measurement Probes (weekly) 19 20 21 22 23 j Participant #4] 20 21 22 23 24 25 Measurement Probes (weekly) • BP1 Score _ _ Baseline trend line Figure 2.10 Brief Pain Inventory: baseline trend line extended into intervention and follow up. The figures above are organized from shortest to longest baseline for ease of interpretation. 100 | Participant #3 | POMS score Level Trend 19 20 21 22 23 Measurement Probes (weekly) | Participant #1 2 3 A 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Measurement Probes (weekly) Follow-up | Participant #2 j 18 19 20 21 22 23 24 Measurement Probes (weekly) Figure 2.11 Profile of Mood States: mean level lines and trend lines for each phase. The figures above are organized from shortest to longest baseline for ease of interpretation. I Participant #3 j POMS score Baseline trend line 2 3 4 3 6 8 9 10 11 12 13 14 15 16 1 7 18 19 20 21 Measurement Probes (weekly) | Participant #2 | 9 10 11 12 13 14 15 18 1 Measurement Probes (weekly) 21 22 23 24 | Participant"**7] Figure2.12 Profile of Mood States: baseline trend line extended into intervention and follow up. The figures above are organized from shortest to longest baseline for ease of interpretation. Baseline Intervention Follow-up j Participant #3 | • 1 2 3 4 5 6 7 6 S 10 11 12 13 14 15 16 Measurement Probes (weekly) 17 18 18 20 21 22 Baseline Intervention Follow-up r A * ^ . | Participant #1 j • 2 3 4 5 6 7 8 8 10 11 12 13 14 15 16 17 18 IB 20 21 Measurement Probes (weekly) £ 8 60 1 50 Baseline Intervention Follow-up | Participant #2 ] • i 8 eo » i so 1 2 3 4 5 6 7 8 B 10 11 12 13 14 15 18 17 18 Measurement Probes (weekly) 19 20 21 22 23 24 Baseline Intervention Follow-up IParticlpant 04 | • 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 18 Measurement Probes (weekly) 20 21 22 23 24 25 • U E F Q Score . _ Level — Trend Figure 2.13 Upper Extremity Function Questionnaire: mean level lines and trend lines for each phase. The figures above are organized from shortest to longest baseline for ease of interpretation. Baseline Intervention Follow-up | Participant #3 | • 2 3 4 5 8 7 8 B 10 11 12 13 14 15 18 17 18 16 20 21 22 Measurement Probes (weekly) • U E F Q Score _ _ Baseline trend line Baseline Intervention Follow-up | Participant 01 | • 8 8 10 11 12 13 14 15 18 17 18 16 20 21 Measurement Probes (weekly) | Pa r t i c ipan t« | Baseline Intervention Follow-up | Participant #3 | • 1 2 3 4 5 8 7 8 6 10 11 12 13 14 15 18 17 18 18 Measurement Probes (weekly) 20 21 22 23 24 25 Figure 2.14 Upper Extremity Function Questionnaire: baseline trend line extended into intervention and follow up. The figures above are organized from shortest to longest baseline for ease of interpretation. 2.10 R E F E R E N C E S 1. Coumeya KS, Friedenreich CF. Relationship between exercise during treatment and current quality of life among survivors of breast cancer. J Psych Oncol. 1997;15(3/4):35-57. 2. Courneya KS, Mackey J, Bell GJ, et al. Randomized controlled trial of exercise training in postmenopausal breast cancer survivors: cardiopulmonary and quality of life outcomes. J Clin Oncol. 2003;21:1660-1668. 3. Young-McCaughan S, Mays MZ, Arzola SM, et al. Change in exercise tolerance, activity and sleep patterns, and quality of life in patients with cancer participating in a structured exercise program. Oncol Nurs Forum. 2003;30:441-454. 4. Kolden G G , Strauman TJ, Ward A, et al. A pilot study of group exercise training (GET) for women with primary breast cancer: Feasibility and health benefits. Psychooncology. 2002; 11:447-456. 5. Blanchard C M , Courneya KS, Laing D. Effects of acute exercise on state anxiety in breast cancer survivors. Oncol Nurs Forum. 2001;28:1617-1621. 6. Pinto B M , MaruyamaN, Engebretson TO, Thebarge RW1. Participation in exercise, mood and coping in survivors of early stage breast cancer. J Psych Oncol. 1998;16(2):45-58. 7. Baldwin M K , Courneya KS. Exercise and self-esteem in breast cancer survivors: an application of the exercise and self-esteem model. J Sport Exerc Psych. 1997;19:334-337. 8. Wingate L. Efficacy of physical therapy for patients who have undergone mastectomies. Phys Ther. 1985;65:896-900. 9. Sandel SL, Judge JO, Landry N, et al. Dance and movement program improves quality-of-life measures in breast cancer survivors. Cancer Nurs. 2005;28:301-309. 10. Berger A , Portenoy R, Weissman D, eds. Principles and Practice of Palliative Care and Supportive Oncology. 2nd ed. Philadelphia: Lippincott, Williams and Wilkins; 2002. 11. Boon H, Belle Brown J, Gavin A, et al. Breast cancer survivors' perceptions of complementary/alternative medicine (CAM): making the decision to use or not to use. Qual Health Res. 1999;9:639-653. 12. Rietman JS, Dijkstra PU, Debreczeni R, et al. Impairments, disabilities and health related quality of life after treatment for breast cancer: a follow-up study 2.7 years after surgery. Disabil Rehabil. 2004;26(2):78-84. 13. Kuehn T, Klauss W, Darsow M, et al. Long-term morbidity following axillary dissection in breast cancer patients -clinical assessment, significance for life quality and the impact of demographic, oncologic and therapeutic factors. Breast Can Res Treat. 2000;64:275-286. 14. Lane K, Jespersen D, McKenzie DC. The effect of a whole body exercise program and dragon boat training on arm volume and arm circumference in women treated for breast cancer. Eur J Cancer Care. 2005;14:353-358. 15. Box R, Reul-Hirche H, Bullock-Saxton JE, Furnival C M . Shoulder movement after breast cancer surgery: results of a randomized controlled study of postoperative physiotherapy. Breast Can Res Treat. 2002;75(l):35-50. 16. Hack T, Cohen L, Katz J, et al. Physical and psychological morbidity after axillary lymph node dissection for breast cancer. J Clin Oncol. 1999;17:143-149. 17. Sugden E, Rezvani M, Harrison JM, Hughes LK. Shoulder movement after the treatment of early stage breast cancer. Clin Oncol. 1998;10:173-181. 62 18. Polinsky M L . Functional status of long-term breast cancer survivors: demonstrating chronicity. Health Soc Work. 1994;19:165-173. 19. Spiegel D. Psychosocial aspects of breast cancer treatment. Sem Oncol. 1997;24(suppl):l-47. 20. Berger B, Owen D. Mood alteration with yoga and swimming: aerobic exercise may not be necessary. Percept Mot Skills. 1992;75:1331-1343. 21. Dorval M, Maunsell E, Deschenes L, et al. Long term quality of life after breast cancer: comparison of 8 year survivors with population controls. J Clin Oncol. 1998;16:487-494. 22. Na Y M , Lee JS, Park JS, et al. Early rehabilitation program in postmastectomy patients: a prospective clinical trial. YonseiMedJ. 1999;40(l):l-8. 23. Anderson BD, Spector A. Introduction to Pilates-based rehabilitation. Orthop Phys Ther Clin North Am. 2000;9:395-411. 24. Lange C, Unnithan V , Larkam E, Latta P. Maximizing the benefits of Pilates-inspired exercise for learning functional motor skills. J Bodywork Mov Ther. 2000;4(2):99-108. 25. Latey P. The Pilates method: history and philosophy. J Bodywork Mov Ther. 2001;5:275-282. 26. LaForge R. Mind-body fitness: encouraging prospects for primary and secondary prevention. J Cardiovasc Nurs. 1997;ll(3):53-65. 27. Pilates J, Miller W. Return to Life through Contrology. Boston, USA: The Christopher Publishing House; 1945. 28. McLain S, Carter C L , Abel J. The effect of a conditioning and alignment program on measurement of supine jump height and pelvic alignment when using the Current Concepts reformer. J Dance Med. 1997;1:149-154. 29. Self B, Bagley A M , Triplett T L , Paulos L E . Functional biomechanical analysis of the Pilates-based reformer during demi-plie movements. JApp Biomech. 1996;12:326-337. 30. McMillan A , Proteau L, Lebe RM. The effect of Pilates-based training on dancers' dynamic posture. J Dance Med Sci. 1998;2(3):101-107. 31. Parrot A. The effects of Pilates technique and aerobic conditioning on dancers' technique and aesthetic. Kines Med Dance. 1993;15:45-64. 32. Fitt S, Sturman J, McClain-Smith S. Effects of Pilates-based conditioning on strength, alignment, and range of motion in university ballet and modern dance majors. Kines Med Dance. 1994;16:36-51. 33. Herrington L, Davies R. The influence of Pilates training on the ability to contract the transverse abdominis muscle in asymptomatic individuals. J Bodywork Mov Ther. 2005;9:52-57. 34. Segal NA, Hein J, Basford JR. The effects of Pilates training on flexibility and body composition: an observational study. Arch Phys MedRehabil. 2004;85:1977-1981. 35. Khan K, Brown J, Way S, et al. Overuse injuries in classical ballet. Sports Med. 1995;19:341-357. 36. Philips C. Clinical Pilates in the management of groin injuries. JSci Med Sport. 1999;2(supp):101. 37. Cozen D. Use of Pilates in foot and ankle rehabilitation. Sports MedArthros Rev. 2000;8:395-403. 38. Watson PJ, Workman EA. The non-concurrent multiple baseline across-individuals design: an extension of the traditional multiple baseline design. JBehav Ther Exp Psych. 1981;12:257-259. 63 39. Backman C L , Harris SR, Chisholm JM, Monette AD. Single-subject research in rehabilitation: a review of studies using A B , withdrawal, multiple baseline, and alternating treatment designs. Arch Phys Med Rehabil. 1997;78:1145-1153. 40. Ottenbacher KJ. Evaluating Clinical Change: Strategies for Occupational and Physical Therapists. Baltimore: Williams and Wilkins; 1986. 41. Clarkson HM. Musculoskeletal Assessment: Joint Range of Motion and Manual Muscle Strength. 2nd ed. Philadelphia: Lippincott Williams and Wilkins; 2000. 42. Cleeland CS, Ryan K M . Pain assessment: global use of the brief pain inventory. Ann Acad Med. 1994;23:129-138. 43. McNair D M , Lorr M, Droppelman LF. EDITS Manual for the Profile of Mood States: Manual. San Diego: Educational and Testing Service; 1992. 44. Harris SR, Hugi M, Olivotto IA, Levine M. Clinical practice guidelines for the care and treatment of breast cancer: lymphedema. CMAJ. 2001;164:191-9. 45. Stott-Merrithew M, Evans B. Stott Pilates Comprehensive Matwork: Manual. Toronto: Merrithew Corporation; 2001. 46. Hayes K, Walton JR, Szomor Z L , Murrell G A C . Reliability of five methods for assessing shoulder range of motion. AustJ Physiother. 2001;47:289-294. 47. Michenbaum D, Turk D. Facilitating Treatment Adherence: A Practitioner's Guidebook. New York: Plenum Press; 1987. 48. Crosbie J. Interrupted time-series analysis with brief single-subject data. J Consult Clin Psych. 1993;61:966-974. 49. Tryon WW. A simplified time-series analysis for evaluation treatment interventions. JAppl Behav Anal. 1982;15:423-429. 50. Crosbie J. The inappropriateness of the C statistic for assessing stability of treatment effects with single-subject data. Behav Assess. 1989;11:315-325. 51. Lucyshyn JM, Albin R. Embedding comprehensive behavioral support in family ecology: an experimental, single-case analysis. J Consult Clin Psych. 1997;65:241-251. 64 Chapter 3 3.1 Primary Findings As the data in Chapter 2 demonstrate, there was a modest functional relationship between implementation of the Pilates intervention and increased shoulder abduction and external rotation ROM. When all participants and affected U E ranges of motion were considered, 10/16 comparisons showed improvement in level from baseline to intervention, and 10/16 exhibited improvement in trend (from stable or deteriorating in baseline, to improving during intervention). On the affected U E , 6/16 comparisons showed improvement in both level and trend: shoulder flexion, abduction and external rotation for Participants 1 and 2. ITSACORR results showed a significant change in shoulder internal R O M (p = 0.028) and external rotation R O M (p = 0.049) on the affected U E for Participant 3. Visual analyses suggest that Participant 1 showed the strongest association between implementation of the Pilates intervention and improved shoulder ROM. It is worth noting that Participant 1 was only six months post radiation treatment when she joined the study. Participant 1 was also: the oldest (71 years) of the sample; did not have a mastectomy; showed the highest overall scores for pain, disturbed mood and difficulty with tasks listed on the U E function questionnaire; and demonstrated the most impaired shoulder R O M on the affected side in flexion, abduction and external rotation when compared to the other three participants. For the reasons listed above, Participant 1 may also have been the most motivated of the group. After completing the study, she continued with supervised and home Pilates sessions and reported increasing benefit from the exercise program. One month after completing the intervention, Participant 2 was diagnosed with cancer that had metastasized to the patellae and skull. Even with metastatic cancer, Participant 2 showed an improvement in both level and trend for shoulder flexion, abduction and external rotation R O M on the affected U E . While Participant 3 was the only participant to show statistically significant change in shoulder R O M for internal and external rotation on the affected U E , visual analysis suggests that, of the women under study, she may have experienced the least change due to the Pilates program. Despite this, Participant 3 rated a 10/10 (indicating "completely satisfied") when asked how satisfied she was with the study outcomes. When asked to comment on the study outcomes, she replied: "/ noticed improvedfunction, in terms of greater strength and mobility. I found both 65 the stretching and resistance exercises extremely helpful in improving my range of motion and strength ", suggesting that the program resulted in change that was of clinical importance to her. The International Classification of Functioning, Disability and Health1 framework defines impairments as "problems in body functions or structure", activity as "the execution of a task or action by an individual" and participation as "involvement in a life situation". Despite their common impairment of reduced shoulder R O M , the participants in this study appeared to be living well with their conditions even at the study's outset, suggesting that impairment may not always result in activity limitation. Rietman et al 2 also reported that the impairments of the arm found in their study of women living with breast cancer did not result in a high state of disability. They did, however, caution that due to the small number of patients studied, their study may have a lack of sufficient power. As the data in Chapter 2 demonstrate, during the baseline phase, none of the participants (with the exception of data from Participant 1 's first day of the study) showed comparatively high scores (i.e. the maximum possible score for each test) on the BPI, the POMS or the UEFQ, indicating that their impairments of reduced shoulder ROM, and where applicable, pain and impaired mood, were not excessively limiting their activities or participation. Over the course of the study, Participants 1 and 4 improved their ability to perform activities (as demonstrated by improved U E F Q scores), and did not report substantial participation restrictions (as demonstrated by scores for the "nominated hobby" and "nominated activity" on the UEFQ). The increase in Participant 2's BPI and U E F Q scores (indicating worsening conditions) over the course of the intervention were largely the result of the aggravation of what she reported as "a longstanding knee problem", later diagnosed as metastases to the patellae. 3.2 Status of Relevant Working Hypotheses In Chapter 1, it was hypothesized that a 3-month Pilates exercise program would improve shoulder ROM, decrease pain, enhance mood and ameliorate U E function in women who had been treated with axillary dissection and radiation for the treatment of Stages I-III breast cancer. 3.2.1 Shoulder R O M Shoulder R O M was the primary dependent measure in this study. While our inclusion criteria required a difference of at least 10° between UEs, three participants (1, 2, 3) had differences between extremities of over 20° in abduction (range: 29-64°) and external rotation (range: 25-54°) at intake. The literature suggests a wide variety of 66 patterns for post-treatment shoulder R O M impairment, suggesting that the response to treatment likely varies among individuals. For example, Box et al's3 findings suggest that shoulder external rotation R O M is not adversely affected by breast cancer surgery or radiotherapy, while Kuehn et al's 4 assessment of 396 patients (retrospectively using a self-report questionnaire and a clinical examination) found a mean abduction restriction of 21°, and no restriction for external rotation on the affected UE . Voogd et al 5 found that 10% (n = 33) of women who had undergone axillary lymph node dissection (range: 0.3 - 28 years before the study) demonstrated a difference of more than 20° in shoulder abduction between the affected and unaffected UEs. While the women in Voogd et al's study were treated with radiation, none had radiation to the axilla. It has been suggested that severe abduction impairment may occur more often in women who are treated with mastectomies.6 Two of three participants in our study who demonstrated abduction impairment had also undergone mastectomies. Visual analyses of shoulder flexion and abduction data in this study indicated improved R O M from baseline to intervention, particularly for the affected U E in Participants 1, 2 and 4, while all participants showed improvement in shoulder external rotation R O M on the affected side. Participants may have tried harder and paid more attention to how they were using the affected U E during the exercise sessions. Additionally, there was simply more room for improvement on the affected U E for the participants. Visual analysis suggested that shoulder internal rotation R O M was the least affected and shoulder external rotation and abduction R O M were the most affected, by the Pilates program. Several of the Pilates exercises in the study required movement into shoulder abduction and external rotation, while only one required notable internal rotation. Additionally, the participants entered the study with baseline postural issues that would likely require more than a three-month exercise intervention to correct. Other authors have reported similar findings relating to shoulder internal rotation ROM. Johansson et al 6 studied women who had undergone axillary dissection with mastectomy (n=26) or segmental resection (n=35) for breast cancer. The women were also treated with breast radiotherapy (n=16), breast and axillary radiotherapy (n=19) or no radiotherapy (n=26). The women were given a daily home exercise program that included five repetitions of active shoulder flexion, abduction, internal and external rotation, three times a day for six months. No data were provided regarding patient adherence to the exercise program. At two years post-treatment, none of the women had regained their pre-treatment internal rotation R O M , with the women who had received radiotherapy to the breast and axilla faring the worst. Internal rotation was the range most affected by the 67 treatments, with women who had been treated with both radiotherapy to the breast and axilla showing the most impairment in all ranges measured. 3.2.2 Level of Pain Except for Participant 1, the others did not report high levels of pain at the study outset. When the BPI scores are examined, each participant demonstrated a decrease in pain from baseline to the end of the intervention (total decreases of 2-53 points), with Participant 1 showing the greatest decrease. At follow-up, Participant l's pain had continued to decrease. Of note, Participant 1 continued to do her Pilates home program exercises two to three times a week during the follow-up period, while none of the other participants did. The increase in Participant 2's pain scores during the intervention could be attributed to the aggravation of a longstanding knee injury, and perhaps to the later-diagnosed patellar metastases. 3.2.3 Mood State The improving mood exhibited by Participants 1, 2 and 4 during baseline makes it difficult to conclude that improvement during intervention was due to the Pilates exercises.7 The improving mood could have been due to factors unrelated to participation in the study or could have resulted from anticipating positive effects from the upcoming Pilates intervention. Two factors make one ponder whether the POMS was the best choice of instruments to measure mood in this study. First, the POMS asked participants to rate various aspects of their mood "during the past week including today" and was completed prior to the Pilates exercise sessions. Participants reported feeling very relaxed and calm after the Pilates sessions, suggesting that the exercise program may have had a transient effect on mood that was unable to be detected by the POMS. Secondly, one item on the social validity questionnaire asked participants to comment on the instruments used to measure change in the study. Participants 1 and 2 felt that the POMS was insensitive, ineffective and inappropriate as a dependent measure. 3.3 Limitations There are several limitations to this study. Testing effects may have threatened internal validity, as evidenced by the improving R O M during several participants' baselines. The baseline data that showed trends consistent with improving R O M , pain, mood or function make it difficult to effectively assess the intervention's effects. Based on 68 these pilot data, it would appear that three baseline data collection sessions are not sufficient to establish "stable" R O M data in shoulder flexion, abduction, internal and external rotation. The fact that the baseline phases had to be extended for two participants (1 and 4) lacked social validity, as the participants were anxious to begin the intervention and found the data collection sessions tedious and boring. Because the rater worked at the Pilates studio where the intervention took place, it was impossible to keep her blind to the study hypothesis, or to the study phase. We accounted for this limitation, however, by using a blind outside observer for inter-observer agreement sessions. The small number of participants limits generalizability, although this was intended to be a pilot study. It is also possible that the intensity of the Pilates exercise program was too low to elicit statistically significant changes. Finally, it may be difficult to measure the exercise dose, as it may have differed slightly from participant to participant for a variety of reasons, i.e. the time required to explain and refine the exercises differed, depending on the individual participants' energy levels (e.g. Participant 3 attended the Pilates sessions after lunch, a time of day when she reported feeling the most "sleepy"), actual time spent exercising per session may have differed (e.g. Participant 3 often started late and had to leave early), and adherence to the home exercise program differed (e.g. Participants 2 and 3 did not complete all the home exercise sessions). 3.4 Strengths Strengths of this study included variability in participant ages (38-71 years), stages of cancer (I-III at diagnosis, with one case of metastatic disease at the study outset), time since initial diagnosis (2.5-5 years), and surgical procedures (lumpectomy, right mastectomy, bilateral mastectomy, bilateral mastectomy with reconstruction). The intervention took place in a community-based Pilates studio with a program typical of what a "regular" Pilates client would receive, supporting the ecological validity of the results. 3.5 Metastatic Disease The successful completion of the intervention by Participant 3, who had been treated with surgery and radiation for metastases to the brain 1.5 years prior to joining the study, is important because of the lack of scientific information on the effects of exercise for women with metastatic disease. Literature searches on exercise and metastatic cancer revealed only: one program description9; three case studies ( 1 0 " l 2 ) ; a feasibility study13; and a randomized controlled, longitudinal trial1 4 that reported on exercise interventions for patients with advanced and 69 progressive cancer. In all cases, patients improved their physical performance and Q O L without experiencing adverse events. It is interesting to note that Participant 3, the participant with metastatic disease, was the only participant who demonstrated statistically significant change in shoulder internal and external R O M on the affected U E . If the guidelines and precautions for exercise during and after cancer treatment" are adhered to, individual differences are considered, exercise programs are of low to medium intensity and performed under the supervision of an oncologist, patients with metastatic breast cancer should be able to undertake exercise studies without risking undue harm. 3.6 Inter-rater Agreement Currently, no standards exist as to what constitutes satisfactory inter-rater agreement for active shoulder R O M in women treated for breast cancer. In Chapter 2 we stated that the inter-rater agreement for shoulder R O M was 74%. This is somewhat below the acceptable standard of 80%, despite the use of a standardized measurement protocol and trained raters. This suggests that shoulder R O M in this population may be more variable than in non-patient populations. A study of patients with shoulder dysfunction conducted by Hayes et a l 1 6 supports our findings. Hayes and colleagues investigated inter-rater reliability for shoulder flexion, abduction, and external rotation in patients with rotator cuff repair (n=6), adhesive capsulitis (n=l) and scapulothoracic fusion (n=l). Their inter-rater correlation coefficients rs were: flexion = 0.69, abduction = 0.69, external rotation = 0.64. It has been suggested that correlation coefficients from 0.40 - 0.75 equal fair to good reliability.16 Shoulder R O M reliability in women treated for breast cancer needs further study. 3.7 Adherence Generally, high levels of participant adherence were seen in this study, particularly for the supervised exercise sessions (86% - 94%). The reasons given for missing the studio exercise sessions included illness, lack of child care and issues related to work. Michebaum and Turk 1 7 suggested that low to moderate intensity exercise programs (of which Pilates is one) tend to have greater adherence rates. Higher education levels and support for exercise from family and friends are also associated with increased participation in planned exercise.18 The participants in this study were university-educated and most (n=3) could enlist support from family and friends. 70 The theory of planned behavior proposes that the intention to perform a behavior is partially determined by the attitude toward the behavior.19 All participants in this pilot study believed that the Pilates exercises would increase shoulder R O M , decrease pain, and improve mood and U E function. The one-on-one nature of the exercise program may have made the relationship between the participants and the instructor more personal, leading them to be more accountable and less likely to miss the exercise sessions. 3.8 Clinically Meaningful Change The authors are not aware of any research that has defined clinically significant change for active shoulder R O M , the BPI, the POMS or the UEFQ. Because the results of the UEFQ represent the participants' opinions regarding their ability to perform activities of daily living and participate in self-selected hobbies and activities, they could be analogous to the participants' sense of whether or not clinically meaningful change resulted from the Pilates intervention. Participant 1 changed the most dramatically in U E F Q scores with a 46-point decrease from the first baseline data point to the last intervention data point. Participant 4 showed a decrease of 10 points, Participant 2 a decrease of one point and Participant 3 showed no change. When the final data points during the intervention phase are compared to the follow-up data points, Participants 1, 2 and 3's U E function scores had increased by nine, nine and three points respectively, indicating increasing activity limitation in the absence of the supervised Pilates exercises. Participant 4 showed no change. Clinically significant change has been described as a "return to normal functioning" that would render the patient's level of functioning consistent with that of well-functioning people.2 0 Functional shoulder R O M is 160° flexion, 145° abduction and 80° internal and external rotation.21 Although we did not hypothesize that participants would attain functional ROM, three achieved functional external rotation R O M in the affected shoulder. None, however, attained functional shoulder abduction or internal rotation R O M on the affected UE . Data for functional shoulder flexion R O M show no consistent patterns across participants. 3.9 Social Validity Experts in single subject research design have suggested the importance of assessing the social validity of study results.22 Rehabilitation interventions are unlikely to have an impact on impairments if the interventions are not viable and acceptable to the consumer/patient. When participants in this study were asked if they would recommend 71 the Pilates program to other women living with breast cancer, all four responded "yes", indicating that they found the program acceptable. Participant 2 stated that she would recommend the Pilates program to other women living with breast cancer for "both the physical and psychological benefits. " When asked to rate (on a 10-point Likert scale) how satisfied they were with the study outcomes, three participants responded "completely satisfied" (10/10) and one responded "almost completely satisfied" (9/10). Participant 1 stated: "/ notice all sorts of changes in my body and really felt the benefit of the exercises, so much that I'll continue with exercises on my own " and "/ think that it (the Pilates exercise program) has positive effects beyond the goals of increased mobility and lessened pain in my affected arm/shoulder. I feel my posture is better, I feel taller, my core strengthened, I've lost inches on my thighs and I have more confidence about my ability to commit to a program ". After completing the study, Participant 1 continued with supervised and home Pilates sessions and reported increasing benefit from the exercise program. When asked if the exercise program had positive or negative effects beyond what had been measured, Participant 4 responded: "/ learned so much. Breathing deeply was wonderful. I learned to overcome my fear, trust my body and movement. I was shocked at how much I could do after a month or so. I feel connected to my body in a way I never did before. I think the numb areas from surgery have felt more connected - almost sensation returned. " When asked what the Pilates exercise program offered that other, more conventional forms of exercise did not, Participant 2 answered: "To realize that 'doing it right' is better, more subtle and more challenging than the 'no pain, no gain' thesis. To experience such an infinite variety of ways of moving and thinking was wonderful. " 3.10 Evaluation of Current Knowledge Current knowledge suggests that women living with breast cancer are not meeting physical activity recommendations for the adult population23 and that they decrease their levels of physical activity by 2 hours per week after a breast cancer diagnosis.24 Holmes et al 2 5 found that physical activity, while beneficial to women with Stage I and II disease, appeared to have particular benefit for women with Stage III disease. Walking 3-5 hours a week at an average pace provided the maximal benefit in reducing mortality from breast disease.25 Little evidence was found for increased benefits of more exercise, suggesting that vigorous activity may be less beneficial than moderate activity for women with breast cancer. Pilates exercise is classified as being low to moderate in intensity. As the number of safe 72 exercise options for women living with breast cancer increases, so might the likelihood that these women will engage in regular physical activity, thereby reducing their impairments and increasing their ability to perform their activities, as well as their level of participation. This thesis research suggests that complementary forms of exercise, such as Pilates, may also have a place in breast cancer rehabilitation. 3.11 Suggestions for Future Research Larger studies that compare Pilates exercises to conventional weight training or physical therapy exercise programs would be worth studying, as would studies that involve interventions of longer duration and the use of more sensitive outcome measures. Additionally, as there are no standard definitions of what constitutes "reduced shoulder mobility" or "acceptable inter-rater and intra-rater shoulder R O M reliability" after breast cancer treatments, research aimed at developing such definitions would be of value. Standard definitions would allow for more accurate comparisons of study results. 3.12 Conclusion As the literature review in Chapter 1 suggest, not every woman who undergoes treatment for breast cancer will develop impaired shoulder R O M but, for those who do, appropriate interventions are necessary. Most of the reduction in shoulder mobility may develop within the first two years after treatment, making early identification of women prone to developing this impairment important. More people are engaging in Pilates as a form of post-rehabilitation exercise therapy, yet few patient-based studies have been conducted. Data suggest that the Pilates program, had a modest effect on shoulder abduction and external rotation. The participants in this pilot study perceived the Pilates exercise to be enjoyable and the program beneficial and did not experience any adverse events. While further study is needed, preliminary data suggest that Pilates could be an effective, enjoyable and safe and exercise option for women after breast cancer treatments. 73 3.13 References 1. World Health Organization. International Classification of Functioning, Disability and Health: ICF. Geneva, Switzerland: World Health Organization; 2001. 2. Rietman JS, Dijkstra PU, Debreczeni R, et al. Impairments, disabilities and health related quality of life after treatment for breast cancer: a follow-up study 2.7 years after surgery. Disabil Rehabil. 2004;26:78-84. 3. Box R, Reul-Hirche H, Bullock-Saxton JE, Furnival C M . Shoulder movement after breast cancer surgery: results of a randomized controlled study of postoperative physiotherapy. Breast Can Res Treat. 2002;75:35-50. 4. Kuehn T, Klauss W, Darsow M, et al. Long-term morbidity following axillary dissection in breast cancer patients -clinical assessment, significance for life quality and the impact of demographic, oncologic and therapeutic factors. Breast Can Res Treat. 2000;64:275-286. 5. Voogd A , Ververs J, Vingerhoets A , et al. Lymphoedema and reduced shoulder function as indicators of quality of life after axillary lymph node dissection for invasive breast cancer. Br J Surg. 2003;90:76-81. 6. Ernst MF, Voogd A C , Balder W, et al. Early and late morbidity associated with axillary levels I-III dissection in breast cancer. J Surg Oncol. 2002;79:151-155. 7. Johansson K, Ingvar C, Albertsson M, Ekdahl C. Arm lymphoedema, shoulder mobility and muscle strength after breast cancer treatment - a prospective 2-year study. Adv Physiother. 2001;3:55-66. 8. Barlow DH, Hersen M. Single-case Experimental Designs: Strategies for Studying Behavior Change. 2nd ed. New York: Pergamon Press; 1984. 9. Segal R, Evans W, Johnson D, et al. Oncology rehabilitation program at the Ottawa Regional Cancer Centre: program description. CMAJ 1999;161:282-285. 10. Kelm J, Alhelm F, Weibenbach P, et al. Physical training during intrahepatic chemotherapy. Arch Phys Med Rehabil. 2003;84:687-690. 11. Crevenna R, Schmidinger M, Keilani M, et al. Aerobic exercise for a patient suffering from metastatic bone disease. Support Care Cancer. 2003;11:120-122. 12. Crevenna R, Schmidinger M, Keilani M, et al. Aerobic exercise as additive palliative treatment for a patient with advanced hepatocellular cancer. Wien Med Wochenschr. 2003;153:237-40. 13. Young-McCaughan S, Mays MZ, Arzola SM, et al. Change in exercise tolerance, activity and sleep patterns, and quality of life in patients with cancer participating in a structured exercise program. Oncol Nurs Forum. 2003;30:441-452. 14. Headley JA, Ownby K K , John LD. The effect of seated exercise on fatigue and quality of life in women with advanced breast cancer. Oncol Nurs Forum. 2004;31:977-983. 15. Courneya KS, Mackey JR. Exercise during and after cancer treatment: benefits, guidelines, and precautions. Intl SportMedJ [serial on-line]. 2001 ;1(5). 16. Hayes K, Walton JR, Szomor ZL, Murrell G A C . Reliability of five methods for assessing shoulder range of motion. Aust J Physiother. 2001;47:289-294. 17. Michenbaum D, Turk D. Facilitating Treatment Adherence: A Practitioner's Guidebook. New York: Plenum Press; 1987. 74 18. Sallis JF, Hovell MF, Hofstetter CR. Predictors of adoption and maintenance of vigorous physical activity in men and women. Prev Med. 1992;21:237-251. 19. Ajzen I. The theory of planned behavior. Organ Behav Hum Decis Process. 1991 ;50:179-211. 20. Jacobson NS, Roberts LJ, Berns SB, McGlinchey JB. Methods for defining and determining the clinical significance of treatment effects. J Consult Clin Psych. 1999;67:300-307. 21. Gerber L, Lampert M, Wood C et al. Comparison of pain, motion, and edema after modified radical mastectomy vs. local excision with axillary dissection and radiation. Breast Can Res Treat. 1992;21:139-145. 22. Backman C L , Harris SR, Chisholm JM, Monette AD. Single-subject research in rehabilitation: a review of studies using A B , withdrawal, multiple baseline, and alternating treatment designs. Arch Phys Med Rehabil. 1997;78:1145-1153. 23. Irwin M L , McTiernan A, Bernstein L, et al. Physical activity levels among breast cancer survivors. Med Sci Sports Exerc. 2004;36:1484-1491. 24. Irwin M L , Crumley D, McTiernan A, et al. Physical activity levels before and after diagnosis of breast carcinoma: the Health, Eating, Activity, and Lifestyle (HEAL) study. Cancer. 2003;97:1746-1757. 25. Holmes MD, Chen W, Feskanich D, et al. Physical activity and survival after breast cancer diagnosis. JAMA. 2005;293:2479-2486. 75 Appendix 2 Participant Consent Form T H E U N I V E R S I T Y O F B R I T I S H C O L U M B I A Page 1 of 5 School of Rehabilitation Sciences Faculty of Medicine T325 - 2211 Wesbrook Mall Vancouver, B.C. Canada V6T 2B5 Tel: (604) 822-7392 Fax: (604) 822-7624 Website: http://www.rehab.ubc.ca/srs.html Effects of Pilates Exercises on Shoulder Range of Motion, Pain, Mood and Upper Extremity Function in Women Living with Breast Cancer: A Pilot Study PRINCIPAL INVESTIGATOR: Susan R. Harris, PhD, PT 604-822-7944 School of Rehabilitation Sciences, UBC CO-INVESTIGATOR: Kim Keays, BHK 604-822-7944 School of Rehabilitation Sciences, UBC STUDY FUNDED BY: Canadian Breast Cancer Research Alliance You have been invited to participate in this study because you had axillary dissection and radiation for stages I or II breast cancer at least one year ago. As a result, you have restricted range of motion in your shoulder. Four women who have had axillary dissection and radiation for stages I or II breast cancer will be invited to participate in this study. The study will take place at Meridian Pilates Studio in Vancouver, BC. PURPOSE The purpose of this study is to examine the effects of a rehabilitative Pilates exercise program on shoulder motion, pain, mood and arm function in women who have had axillary dissection (removal of lymph nodes under the arm) and radiation therapy for stages I or II breast cancer. INDIVIDUALS WHO ARE ELIGIBLE Women who are at least one-year post axillary dissection and radiation therapy for stages I or II breast cancer, who have restricted shoulder movement (i.e. a difference of 10 degrees or more between the surgical and non-surgical arm) secondary to breast cancer treatment. INDIVIDUALS WHO ARE NOT ELIGIBLE Those individuals who do not meet the above stated criteria as well as women who are; actively undergoing chemotherapy treatment or attending regular physiotherapy, chiropractic or massage therapy or psychological counseling; women who have previous shoulder injuries or health problems other than cancer and related side-effects will be excluded from the study. Version 6, Oct. 10, 2005 Page 2 of 5 TEST PROTOCOL The order of testing wil l be: active shoulder motion on both sides, Brief Pain Inventory, Profile of Mood States - Short Form and Upper Extremity Function questionnaire. You wil l also be asked to keep a daily diary of your physical activities. Active shoulder motion tests wil l include flexion (lifting your arm in front of you), abduction (lifting your arm to the side), internal rotation (elbow bent at 90 degrees, arm lifted away from side so that elbow is in line with shoulder, palm facing forward, rotate arm forward toward floor) and external rotation (elbow bent at 90 degrees, arm lifted away from side so that elbow is in line with shoulder, palm facing forward, rotate arm backward toward floor). PILATES EXERCISES Pilates is a mind-body exercise approach based on Eastern theories of body-mind-spirit interaction combined with Western theories of biomechanics, motor learning (how your body produces movement), and core stability (strengthening of the muscles of the torso). The proponents of this approach claim that regular Pilates practice results in relaxation and control of the mind, enhanced body and self-awareness, improved core stability, better coordination, more ideal posture, greater joint motion, uniform muscle development and decreased stress. A certified Pilates instructor will conduct all exercise sessions. Sessions wil l involve the use of Pilates specific exercise equipment. Exercise programs wil l be individualized to suit your specific needs. You wil l wear exercise attire during the sessions. Form fitting clothing such as leggings and tank tops are most beneficial as they allow the instructor to have a better sense of body positioning. You wil l wear a compression garment on your affected arm during the exercise sessions. You may refuse to perform any movements or tests that the investigator requests. TEST PROCEDURES Shoulder Motion You wil l lie on a hard surface (i.e. table, portable massage bed, mat on the floor) while the investigator uses a 12-inch goniometer (plastic device used to measure range of movement of the arm) to measure flexion (lifting your arm in front of you), abduction (lifting your arm to the side), internal rotation (turning your straight arm so that your palm faces backward) and external rotation (turning your straight arm so that your palm faces forward) for both of your shoulders. Pain - Brief Pain Inventory (BPL) The BPI is a questionnaire that consists of 15 items, including pain drawing and 7 pain interference questions, rated on an 11-point scale. The BPI provides information on the intensity and the degree to which pain interferes with function. Version 6, Oct. 10,2005 Page 3 of 5 Profile of Mood States Short Form (POMS SF') The POMS-SF is a questionnaire that rates a variety of mood states (including anxiety, depression, anger, vigor, fatigue and confusion) using a 30-item adjective checklist. Each item is rated on a 5-point scale. The test provides a score for total mood disturbance. Upper Extremity Function Questionnaire (UEFQ') The UEFQ is a questionnaire that wil l be used to rate the degree of difficulty with which you can perform tasks that involve your arms. For each task, you wi l l rate the degree of difficulty on a 10-point scale that ranges from "no difficulty" with the task to "completely unable to do" the task. T IME C O M M I T M E N T You wil l attend 3 private (i.e. one on one) Pilates sessions every week for 12 weeks at Meridian Pilates Studio in Vancouver, B C . Each studio based exercise session wi l l last for 55 minutes. For the same 12 weeks that you are attending the studio based Pilates sessions, you will be given an additional 30-minute Pilates exercise program to perform on your own (at home) once a week. You wil l be randomly assigned (i.e. the number wi l l be picked out of an envelope) to 3, 5, 7, or 9 baseline data collection sessions. These sessions wil l establish your pre-Pilates exercise function. These sessions will take place either in your home or at Meridian Pilates Studio and wil l include measurements of shoulder motion, pain, mood and upper extremity function. Once the exercise sessions begin, the same measurements wi l l take place twice a week for 12 weeks. Of the two weekly data collection sessions, the first should take approximately 10 minutes and the second should take approximately 25 minutes. The first data collection session wil l take place early in the week (i.e. Monday), and the second wi l l take place at the end of the week (i.e. Friday). If those days are not convenient, an alternate schedule can be arranged. Should you choose not to participate in this study, or i f you do not meet the inclusion criteria, we will refer you to exercise professionals who specialize in breast cancer rehabilitation. If we are aware of any researchers who are recruiting women living with breast cancer to participate in their studies, we wi l l provide you with the appropriate contact information. M O N E T A R Y COMPENSATION There is no monetary compensation for participation in this study. If you do not have one already, a compression sleeve (an elastic stocking worn on the affected arm during exercise, thought to decrease the chance of developing lymphedema) wil l be provided for you, providing you obtain a physician's prescription for it. RISKS A N D BENEFITS You may experience some muscle soreness secondary to the exercise program. This is common and should subside within 48-72 hours of the exercise session. Version 6, Oct. 10,2005 Page 4 of 5 There is a theoretical risk that you could develop lymphedema (swelling) in your affected arm due to your participation in this study, however this risk is thought to be minimal. Recent research has shown that women living with breast cancer can engage in vigorous upper exfternity exercise without increasing their risk of developing lymphedema. Pilates, a much gentler form of exercise that focuses on the whole body, is not expected to contribute to the development of lymphedema. In the unlikely event that you should develop lymphedema, you wil l be referred to a qualified physiotherapist for treatment. The benefits of this research is that it wi l l lead to a better understanding of whether or not Pilates exercise can contribute to the physical and psychological rehabilitation of women who have undergone axillary dissection and radiation for stages I or II breast cancer. The investigator wi l l cover the cost of the private Pilates sessions. CONFIDENTIALITY Your confidentiality wi l l be respected. No information that discloses your identity wi l l be released or published without your specific consent to the disclosure. However, research records and medical records identifying you may be inspected in the presence of the principal investigator or his or her designate by representative of the U B C Research Ethics Board or by Health Canada for the purpose of monitoring the research. However, no records which identify you by name or initials wil l be allowed to leave the investigator's offices. C O N T A C T Any questions that you have, have been answered to your satisfaction by the investigator(s). You understand that i f you have any further questions or desire more information with respect to the study, or i f you experience any adverse effects, you should contact Dr. Susan Harris or any of the investigators. If you have any concerns about your treatment or rights as a research subject you may contact the "Research Subject Information Line" office at U B C (604-822-8598). Version 6, Oct. 10, 2005 Page 5 of 5 CONSENT I have read the above comments and wish to proceed with the evaluation. I understand that participation in this study is entirely voluntary and that I may refuse to participate or I may withdraw without any consequences to my continuing medical care. I understand that I do not waive my legal rights by signing this consent form. I have received a copy of this consent form. 1. Name . Date Signature 2. Witness . D a t e Signature 3. Investigator D a t e Signature Version 6, Oct. 10,2005 Appendix 4 Brief Pain Inventory - Short Form Brief Pain Inventory (Short Form)' Study ID#_ Date: / Time: " Name: Hospital#_ Do not write above t h i s l i n e " Last F i r s t Middle I n i t i a l 1) Throughout our l i v e s , most o f us have had p a i n from time t o time (such as minor headaches, sprains, and toothaches) Have you had pai n other than these everyday kinds of pa i n today? !• yes 2. no 2) On the diagram, shade i n the areas where you f e e l p a i n Put an X on the area that hurts the most. 3) Please r a t e your p a i n by c i r c l i n g the one number that best d e s c r i b e s your p a i n at i t s WORST i n the past 24 hours. 0 No p a i n B 9 10 Pain as bad as you can imagine i6 r a t e your pain by c i r c l i n g the one number that best ibes your pain at i t s LEAST i n the past 24 hours. ° 1 2 3 4 5 6 No pain 7 8 9 10 Pain as bad as you can imagine 5) Please r a t e your p a i n by c i r c l i n g the d e s c r i b e s your pain on the AVERAGE. one number that best 0 1 2 3 4 5 6 No p a i n 7 8 9 10 Pain as bad as you can imagine 6) Please r a t e your pain by c i r c l i n g the how much p a i n you have RIGHT NOW. one number t h a t t e l l s 0 1 2 3 4 5 6 No pain 7 8 9 10 Pain as bad as you can imagine ) What treatments or medications are you r e c e i v i n g f o r Dain? 3) In the past 24 hours, how much RELIEF have pain treatments or medications provided? Please c i r c l e the one percentage that most shows how much. 0 % 1°% 20% 30% 40% 50% 60% 70% §0% 90% 100% No n , . _ Complete r e l i e f , . Z r e l i e f 9) C i r c l e the one number that describes how, during the past 24 hours, PAIN HAS INTERFERED with your: A. General A c t i v i t y : ° 1 2 3 4 5 I 7 i 9 J7j Does not „i„.. i . . Completely i n t e r f e r e . t , i n t e r f e r e s B. 0 1 2 3 4 5 6 7 i 9 io D 0 ° s " o t Completely l n t e r f e r e i n t e r f e r e s C. Walking a b i l i t y 0 1 2 3 4 5 6 7 8 9 10 Does not Completely i n t e r f e r e i n t e r f e r e s D. Normal work, (includes both work o u t s i d e the home and housework) 0 1 2 3" 4 5 6 7 8 9 10 Does not Completely i n t e r f e r e i n t e r f e r e s E. R e l a t i o n s with other people I \ 1 1 1 5 6 7 8 9 TO Does not , i n t e r f e r e Completely i n t e r f e r e s Sleep 0 1 2 3 4 5 6 7 8 9 To Does not ° 3 , i n t e r f e r e Completely i n t e r f e r e s G. Enjoyment of l i f e I \ 5 5 * 5 6 7 i 9 Io Does not _ _ , i n t e r f e r e Completely i n t e r f e r e s Used with permission. May be d u p l i c a t e d and used i n c l i n i c a l p r a c t i c e Source: Dr. Charles Cleeland, Anderson Cancer Center, Pain Research Group, 1100 Holcombe, Houston, TX 77030. Appendix 5 Profile of Mood States - Short Form NAME DATE . SEX: Male ® Female © Identification No. Below is a list of words that describe feelings people have. Please read each one carefully. Then fill in ONE circle under the answer to the right which best describes HOW YOU HAVE BEEN FEELING DURING THE PAST WEEK INCLUDING TODAY. The numbers refer to these phrases. © = Not at all © = A little © = Moderately © = Quite a bit © = Extremely 1. Tense . . . 2. Angry . . . 3. Worn out 4. Lively . . . 5. Confused . 6. Shaky . . . 7. Sad 8. Active . . . 9. Grouchy . . 10. Energetic . 11. Unworthy . = £ -5 -J? 1 0 « « ? "5 <D © © o - ^ 5 x Z < 2 0 U J • © O © © © •®o©©© © O © © © ©©©©© ©o©©© ©©©©© @ O © © 0 © O © ® ® © O © © © © O © ® ® © 0 © © © 12. Uneasy . . . 13. Fatigued . . 14. Annoyed . , 15. Discouraged 16. Nervous . 17. Lonely . . 18. Muddled . 19. Exhausted 20. Anxious . . 21. Gloomy . . 22. Sluggish JO r « i • • J •5 = ^ "Ii -s Z < 2 0 L J •®o©@© •®o©©© •©©©©© •®o©®© •©©©©© •®o©©© • © © © © © • © © © © © • ® © @ © ® • © © © © © •®o©®© 23. Weary . . 24. Bewildered 25. Furious . . 26. Efficient . 27. Full of pep D — O '3 S< Z < 2 O LU © 0 © © © © © © © © © 0 © © © © © © © © © © © © © 28. Bad-tempered © © © © © 29. Forgetful . . . © © © © © 30. Vigorous . . . ® © © © 0 MAKE SURE YOU HAVE ANSWERED EVERY ITEM. (ffl R) POMS COPYRIGHT© 1989 EdlTS/Educational and Industrial Testing Service, San Diego, CA92107. ^U-v Reproduction of this form by any means strictly prohibited. SHORT FORM 86 Appendix 6 Upper Extremity Function Questionnaire Upper Extremity Function Questionnaire Please circle the number which best describes your ability to perform the task in question today. (range from l=no difficulty with the task to 10=completely unable to do the task) 1. Scratching/washing the top of your opposite shoulder blade 1 2 3 4 5 6 7 8 9 lo" No difficulty Completely Unable to do 2. Reaching overhead (i.e. to a cupboard) T 2 3 4 5 6 7 13 9 IF No difficulty Completely Unable to do 3. Driving a car for greater than IS minutes 1 2 3 4 ii 6 7 i§ 9 IO" No difficulty , • Completely Unable to do 4. Pulling a shirt on/off over your head 1 2 3 4 5 6 7 8 9 10 No difficulty Completely Unable to do 5. Brushing or combing your hair/fixing your wig or head scarf I 2 3 4 5 6 7 8 9 IfJ No difficulty Completely Unable to do 6. Doing up a back fastening bra 1 2 3 4 5 6 7 8 9 IfJ No difficulty Completely Unable to do 1 87 7. Zipping up a buck fastening dress 1 2 3 4 5 6 7 8 9 10 No difficulty Completely Unable to do 8. Wiping down a table top or bench 1 2 3 4 5 6 7 8 9 10 No difficulty Completely Unable to do 9. Making a double bed 1 2 3 4 5 6 7 8 9 10 No difficulty Completely Unable to do 10. Pushing a full supermarket trolley with two hands 1 2 3 4 5 6 7 8 9 l f J No difficulty Completely Unable to do 11. Nominated sport/recreational activity 1 2 3 4 5 6 7 i? 9 lb" No difficulty Completely Unable to do (Sport/Activity: ) 12. Nominated hobby 1 2 3 4 5 6 7 8^  9^  lb" No difficulty Completely Unable to do (Hobby: ) Questionnaire modified from: Box R, Reul-Hirche H, Bullock-Saxton JE, Furnival CM. (2002) Shoulder movement after breast cancer surgery: results of a randomized controlled study of postoperative physiotherapy. Breast Can Res Treat. 75<1):35-50. 2 88 Appendix 7 Social Validity Questionnaire Please read each question carefully. Your feedback will help us to improve future programs. Project Goals A . Please rate how important the following project goals are to you: 1. Improved shoulder range of motion: 1 Not important 1 Not important 1 Not important 1 Not important 2. Decreased pain: 4 5 6 7 3. Improved mood: 4 5 6 7 4. Improved upper extremity function: 3 4 5 6 7 9 10 Very Important 9 10 Very Important 9 10 Very Important 9 10 Very Important B. Have you experienced any post breast cancer treatment problems, other than the four listed above, that you would like to address? If so, what are they? Comments/suggestions regarding project goals: Strategies Used C. In your opinion, how acceptable were the following: 1. The Pilates exercise program 3 4 5 6 7 8 1 2 Not acceptable 9 10 Completely acceptable 2. The private exercise sessions (when compared to possible group classes) 1 2 Not acceptable 1 2 Not acceptable 8 9 10 Completely acceptable 3. The setting (Meridian Pilates Studio) 3 4 5 6 7 8 9 10 Completely acceptable 4. The length of the baseline phase 89 1 2 3 4 5 . 6 7 8 9 10 Not acceptable Completely acceptable 5. The frequency of the data collection sessions 1 2 3 4 5 6 7 8 9 10 Not acceptable Completely acceptable 6. The length of the intervention (i.e. the Pilates program) phase 1 2 3 4 5 6 7 8 9 10 Not acceptable Completely acceptable 7. The frequency of the studio exercise sessions (3x/week) 1 2 3 4 5 6 7 8 9 10 Not acceptable Completely acceptable 8. The frequency of the home exercise sessions (lx/week) 1 2 3 4 5 6 7 8 9 10 Not acceptable Completely acceptable Comments/suggestions regarding the acceptability of the strategies used in the study: D. In your opinion, were the instruments used to measure change in this study (goniometer, Brief Pain Inventory, Profile of Mood States and Upper Extremity Function Questionnaire) sensitive, effective and appropriate? If not, please explain. Study Outcomes E. Overall, how satisfied are you with the study outcomes? 1 2 3 4 5 6 7 8 9 10 Not satisfied Completely satisfied Comments regarding overall satisfaction with study outcomes: F. Did this exercise program have positive or negative effects beyond what has been measured? If so, please list them. G. What, if anything, did this Pilates exercise program offer you that other, more conventional forms of exercise, have not? H. What did you enjoy the most about participating in this exercise program? What was the most significant benefit? (Please make a distinction between the exercise program and the entire study (i.e. do not consider all of the data collection sessions when you answer this). I. What did you enjoy the least about participating in this exercise program? (Please make a distinction between the exercise program and the entire study (i.e. do not consider all of the data collection sessions when you answer this). J. Would you recommend a Pilates exercise program to other women who have limited shoulder range of motion secondary to breast cancer treatments? Why or why not? Thank you! 90 Appendix 8 Exercise Barrels Pectoral stretch over 2 arc barrels Spine corrector side stretch Cadillac Roll down Latissimus dorsi pull Reformer Footwork Abdominal preparation/100 Mid-back series Bend and stretch Back rowing preparation Front rowing preparation Short box Knee stretches Running Mat Swan Theraband Mid-back pull Shoulder external rotation Pilates Studio Program8 Progression/Notes Over Vi foam roll, then full foam roll With instructor assist Arms crossed on bar Single arm pull On mat first Or on cadillac Or on cadillac Start sitting on long box, progress to without box once able to sit comfortably Straight arm pull Round back, straight back Round back, straight back Preparation Seated Seated, elbow at 90° B For more information on the Pilates exercises, please consult the Stott Pilates Reformer and Cadillac Manuals. Stott Pilates | 2200 Yonge Street, Suite 500, Toronto, Ontario M4S 2C6 (ph) 1-800-910-0001 91 Appendix 9 Pilates Home Program c First month Seated breathing Anterior pelvic floor and transverse abdominals isolation Knee folds Barbie arms Spinal rotation/rib opener Shell stretch Hip rolls Wall roll down Second month Change Barbie arms to arm circles Change spinal rotation to "around the clock" Add: Small weight and arm circles to wall roll down Spine twist seated Mid-back Theraband pull Third month Add: Abdominal preparation/100 Seated shoulder external rotation with Theraband Baby swan For more information on the Pilates exercises, please consult the Stott Pilates Matwork Manual. Stott Pilates | 2200 Yonge Street, Suite 500, Toronto, Ontario M4S 2C6 (ph) 1-800-910-0001 Appendix 10 Treatment Adherence Guidelines (Michenbaum & Turk 1987, p.244) 1) anticipate non-adherence 2) consider the prescribed self-care regimen from the patient's perspective 3) foster a collaborative relationship based on negotiation 4) be patient oriented 5) customize treatment 6) enlist family support 7) provide a system of continuity and accessibility 8) make use of other health care providers and personnel as well as community resources 9) repeat everything 10) don't give up Appendix 11 Treatment Adherence Questionnaire 1) What is your adherence history? For example; have you been able to stick with your "new year's resolutions" in the past; have you been able to commit to previous exercise programs; when you decide to undertake a new activity are you able to fulfill your commitment to yourself? 2) What are your expectations regarding: a. The intervention (Pilates) b. The goals of intervention (increase shoulder range of motion, decrease pain, improve mood and upper extremity function) c. The risks vs the benefits of the intervention d. Your sense of self-efficacy e. Can you identify any life circumstances that might affect your adherence 3) To what extent do you believe that you will be able to perform the exercise program: a. at the studio b. at home 4) Do you believe that doing your exercises will lead to increased ROM, decreased pain, improved mood and upper extremity function? 5) How important is achieving this goal to you? 6) What barriers can you foresee? 7) What can you do to make adherence easier? 8) What problems can you anticipate? 9) Can you enlist family support (spouse, children etc)? 94 

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