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Targeting functional fitness, hearing and health-related quality of life in older adults with hearing… Lambert, Justin; Ghadry-Tavi, Rouzbeh; Knuff, Kate; Jutras, Marc; Siever, Jodi; Mick, Paul; Roque, Carolyn; Jones, Gareth; Little, Jonathan; Miller, Harry; Van Bergen, Colin; Kurtz, Donna; Murphy, Mary A; Jones, Charlotte A Jan 28, 2017

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STUDY PROTOCOL Open AccessTargeting functional fitness, hearing andGAR sessions. GAR sessions will include education about hearing, hearing technologies, enhancing communication skills,and psychosocial support. Pre-post trial data collection and measures will include: functional fitness (gait speed, 30-s Sit toility of an addressingultsLambert et al. Trials  (2017) 18:47 DOI 10.1186/s13063-017-1792-zDiscovery Ave, Kelowna, BC V1V-1V7, CanadaFull list of author information is available at the end of the article* Correspondence: charlotte.jones@ubc.ca8Southern Medical Program, #321 Reichwald Health Sciences Center, 1088aimed at addressing functional fitness declines associated with the disability of HL. This pilot trial will provideabout the physical, mental and social impacts on health related to HL as a disability. This will inform the feasiblarger RCT and preliminary evidence about the initial effects of a novel, community-based, holistic interventioboth the negative psychosocial and functional physical effects of HL among older adults.Trial registration: ClinicalTrials.gov, NCT02662192. Registered on 14 January 2016Keywords: Hearing loss, Disability, Functional fitness, Auditory rehabilitation, Loneliness, Socialization, Older adStand Test), hearing and health-related quality of life, loneliness, depression, social participation and social support. At trialend, feasibility (recruitment, randomization, retention, acceptability) and GAR will be evaluated.Discussion: Despite evidence suggesting that HL is associated with declines in functional fitness, there are no studiesknowledgewith hearing loss: Walk, Talk 'n' Listen,study protocol for a pilot randomizedcontrolled trialJustin Lambert1, Rouzbeh Ghadry-Tavi1, Kate Knuff1, Marc Jutras1, Jodi Siever1, Paul Mick2, Carolyn Roque1,Gareth Jones3, Jonathan Little3, Harry Miller4,1, Colin Van Bergen5, Donna Kurtz6, Mary Ann Murphy7 andCharlotte Ann Jones8*AbstractBackground: Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increasedrisk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of thispilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improvefunctional fitness, social connectedness, hearing and health-related quality of life in older adults with HL.Methods: This 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample ofambulatory adults aged 65 years or older with self-reported HL. Following baseline assessments, participants will berandomized to either intervention (exercise, health education, socialization and group auditory rehabilitation (GAR)) orcontrol (GAR only) groups. The intervention group will attend a local YMCA twice a week and the control group once aweek. Intervention sessions will include 45 min of strengthening, balance and resistance exercises, 30 min of groupwalking at a self-selected pace and 60 min of interactive health education or GAR. The control group will attend 60-minhealth-related quality of life in older adults© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.BackgroundConceptual frameworkThe World Health Organization (WHO) InternationalClassification of Functioning, Disability and Health (ICF)[1] is a clinically relevant framework that describes dis-ability in terms of physical impairments, activity limita-tions, participation restrictions and the contextualfactors (environmental and personal) that interact to in-fluence the disability (Fig. 1). The ICF provides an excel-lent, inclusive framework to consider the far-reachingeffects of hearing loss (HL) as a disability and to evaluatethe influence of interventions, such as the Walk, Talk ‘n’Listen (WTListen) program, on participants with HL.Hearing loss is one of the most common chronicLambert et al. Trials  (2017) 18:47 Page 2 of 12health problems in North America. Analysis of the audi-ometry data from the 2001–2008 cycles of the NationalHealth and Nutrition Examination Surveys revealed thatnearly 20% of Americans of 12 years of age or older haveunilateral or bilateral HL [2]. The prevalence of HL in-creases with age. Audiometry results from the 2012 and2015 Canadian Health Measures Survey [3] indicatedthat 78% of adults aged 60 to 79 years have audiometri-cally measured HL and that over 77% are undiagnosed.The disability of HL may influence or be influencedby interactions between all domains of the ICFincluding personal factors (e.g., socioeconomic, educa-tion, coping mechanisms), limitations to environmen-tal factors (e.g., relationships, supports, attitudes),body functions (e.g., declining auditory, cognitive andmusculoskeletal function), limitations in activities ofdaily living (e.g., self-care, mobility), and participationrestrictions (e.g., communication, relationships, sociallife). Epidemiologic studies have established independ-ent associations between HL and poorer health-related quality of life (HRQOL: physical and mentalhealth domains) [4, 5], social isolation [6, 7], depres-sion [8], incident dementia [9], cognitive decline [10],Fig. 1 The World Health Organization International Classification ofFunctioning, Disability and Health frameworkincreased physical dependence in activities of daily living(admission to a nursing home or requiring assistance athome) [7, 11], increased sedentary time [12], decline infunctional fitness [13] including gait speed [14, 15], in-creased falls [16], hospitalizations [17] and a near 36% in-crease in age- and sex-adjusted cardiovascular and all-cause mortality (ACM) [18–21]. Applying the ICF frame-work to those with HL suggests that the ideal interventionaimed at addressing HL as a disability should be holisticand address personal, environmental, psychosocial andphysical domains.Provision of hearing aids (HAs) and one-on-one orgroup auditory rehabilitation (GAR) are currently themost common approach to treating HL. ProvidingHAs, education about hearing and hearing devices/technologies, psychosocial support and enhancingcommunication skills are the primary components ofauditory rehabilitation [22]. Effective one-on-one orgroup auditory rehabilitation (AR) optimizes environ-mental and personal functioning and with theprovision of HA, may address body functions (im-paired auditory function) along with decreasing activ-ity and participation limitations [23–26]; however, itdoes not address the well-documented declines infunctional fitness (musculoskeletal: gait speed, acti-vates of daily living (ADL) performance and increasedrisk for falls).While there is some longitudinal observational evidencethat two or more sessions of “muscle strengthening”exercise per week may increase longevity among adultswith moderate to severe HL [27], there are no publishedinterventions addressing the ICF domains of body func-tion, activity and participation limitations related todeclines in functional fitness in older adults with HL.Consistent with the ICF approach to HL as a disability,Chia et al. [5] emphasize the importance of under-standing the synergist effects of physical disabilities,medical and social conditions on HRQOL in olderadults. There is a need for more research exploring theeffectiveness of strategies that not only address the ICFdomains of activity and participation limitations relatedto impaired auditory function but that also improvefunctional fitness, gait speed and ADL, all of which arenegatively impacted by HL.Based on the literature and cocreated in collaborationwith nearly 400 low-income seniors, Walk ‘n’ Talk forYour Life (WTL) [28] is a 10-week community-basedprogram of socialization/health education (SHE) andgraduated physical exercise program for older adults atrisk of social isolation and loneliness (SI&L). While notdesigned for participants with HL, 30 of the first 150WTL participants self-reported HL [29]. Compared tothose without HL, participants with HL tended at base-line to be lonelier, to have a higher prevalence ofpossible mild depression and to have lower levels offunctional fitness. By program end, both those with andwithout HL showed promising improvements in func-tional fitness and decreases in loneliness measures. In-depth, one-on-one interviews were performed withparticipants with self-reported HL to answer two ques-tions: (1) Did HL affect the acceptability of WTL and ifso, how? and (2) What did they feel might improve theprogram to address the impact (if any) of HL? From thisinformation, (manuscript submitted) the WTListenintervention tailored for older adults with HL wasdeveloped.In partnership with the Young Men’s Christian As-sociation (YMCA) of Okanagan, the aim of this pilotrandomized controlled trial (RCT) is two-fold: (1) toexplore the feasibility and acceptability of the novelWTListen intervention for older adults with HL and(2) to provide preliminary information about the re-search question: In older adults with HL, what effectdoes a group exercise and socialization/health educa-tion intervention added to GAR have on: (a) bodyfunction impairments: (functional fitness) and activitylimitations and participation restrictions (hearing-re-lated quality of life, HRQOL) and (b) perceptions ofloneliness and social network?MethodsTrial designIn this single-blind, randomized controlled pilot trial, 60ambulatory adults aged 65 years or older, with self-reported HL will be randomized into either the WListenintervention group (exercise, SHE sessions and GAR) orthe control group (GAR alone) (see Fig. 2 and the Stand-ard Protocol Items: Recommendations for InterventionalTrials (SPIRIT) Checklist (Additional file 1) and theSPIRIT figure (Fig. 3)). Control-group participants willbe asked not to change their current physical activitylevels and will be offered the 10-week exercise compo-nent after the trial is complete. The trial will take placein the “real life” context of a local sports and recreationfacility (YMCA Okanagan) and will be free of charge toall participants. Interactive GAR and SHE sessions willbe small, closed groups of no more than 12 participantsand facilitated for the most part by CAJ and KK. Anaudiologist (KVB) will deliver a GAR session on theanatomy and process of HL and hearing assistive tech-nologies. This trial will examine recruitment efficacy,reasons for participant interest in joining the trial, attri-tion rates and reasons, acceptability of GAR, SHE andphysical activity interventions along with changes in thefunctional fitness and psychosocial measures relative toLambert et al. Trials  (2017) 18:47 Page 3 of 12Fig. 2 Participant time line: Consolidated Standards of Reporting Trials (CONSORT)-style flow chartFig. 3 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure. *Recommended content can be displayed using variousschematic formats. See SPIRIT 2013 Explanation and Elaboration for examples from protocols. **List specific timepoints in this rowLambert et al. Trials  (2017) 18:47 Page 4 of 12the control group. The findings will inform the design ofa larger, multisite RCT.Trial population and randomizationAmbulatory, community-dwelling adults aged 65 years orolder will be invited to participate either directly by theiraudiologist, or through posters and information sheetsplaced in 10 Kelowna audiologists’ offices, otolaryngolo-gists’ offices, local seniors’ venues, the YMCA, local non-profit seniors’ agency newsletters and local newspaper ads.Potential participants who call the trial telephone numberFinal eligibility assessmentFinal eligibility assessment (functional fitness testing)and baseline questionnaire completion will take place atthe trial site (a local YMCA site) and be performed bymembers of the trained research team after signed in-formed consent has been obtained.RandomizationParticipants will be randomized (Stata® (StataCorp. 2013.Stata Statistical Software: Release 13, College Station,quence will be concealed from the researchers who willtr1. Unable to ambulate/walk for exercise2.Serious illness limiting their ability to exercise orLambert et al. Trials  (2017) 18:47 Page 5 of 12will be given information by the trial coordinator (TC:CR) about the trial and, if still interested, will undergo apreliminary telephone eligibility assessment.Preliminary telephone eligibility assessmentTable 1 provides the detailed inclusion and exclusion cri-teria. The trial coordinator, the principle investigator (PI:CAJ), will verbally review the Consent Form with poten-tial participants and answer any questions that arise..After verbal consent is obtained, participants will beagain asked, “Do you have difficulty hearing when con-versing with another person in a noisy environment?”[30]. Those answering “yes” will be guided through thevalidated Physical Activity Readiness Questionnaire(PARQ+) [31] to confirm that they meet the inclusioncriteria and are healthy enough to participate in theintervention without exacerbating any existing symp-tomatology [32]. Those who pass the initial PARQ+screen and/or those who provide a physician-signedCSEP letter of “exercise readiness” and: Self-report less than 150 min per week of physicalactivity [33] Have not participated in any organized exerciseprogram for at least 6 months Are available and willing to attend at least 80% ofthe 10-week sessions in addition to completingbaseline and final assessments, will be invited forfinal eligibility assessmentTable 1 Inclusion and exclusion criteria of the Walk, Talk ‘n’ ListenInclusion criteria1. Aged 65 years or older2. English speaking3. Able to sign written informed consent4. Hearing Handicap in the Elderly (HHIE-25) score of>17 [47] or a previous diagnosis of HL5. Clearance to safely partake in the trial’s physicalactivities: PARQ+ (Physical Activity ReadinessQuestionnaire [66]) or written physician clearancefor participation6. Moderate functional fitness: gait speed >0.72 and<1.8 m/s [67] and/or 30-s STS ≥6 and <21 (within orbelow published sex- and age-adjusted average levels)30-s STS 30-s Sit to Stand Test, HL hearing losscomplete the trial3. Contraindications to exercise: failure to fulfill theprerequisites of the PARQ+4. Uncontrolled hypertension (≥160/>90 mmHg)5. Signs or symptoms of alcohol or substancedependence6. Refusal to be randomized7. Lack of transportation to the trial8. Unable to commit to attending 80% or more ofconfirm consent and eligibility with participants beforeallocation is revealed. Participants will be enrolled andassigned to the time and day(s) of the week by the pro-ject coordinator in consideration of their personal sched-ules. It is not feasible to mask participants or researchersafter group allocation as the intervention includes an ex-ercise program and the control does not.Research team developmentThe research team will include the PI, the PC, two tofour students per semester and their faculty supervisors(CAJ, HM, DK, GJ, JL, M-AM) from medicine, psych-ology, nursing, human kinetics and social work, respect-ively. This research team will be responsible for pre-andpost-intervention assessments and training students andstaff to conduct sessions in either the intervention or thecontrol group.ialExclusion criteriaTX, USA: StataCorp LP) by an independent statistician(JS) into two groups, using permuted blocks of randomsizes, stratifying on gender and age (below 73 years/73+years) to ensure even distribution of these variables. Theblock sizes will not be disclosed to ensure concealment[34, 35]. When either of a couple is randomized to a dif-ferent group (one to the control group and one to theintervention group), a fair coin toss will be used to de-cide which group they will both be assigned to (heads =control; tails = intervention). The randomization se-the sessionsLambert et al. Trials  (2017) 18:47 Page 6 of 12InterventionThe trial will occur at different times on the same daysfor the intervention and the control groups. The inter-vention groups (GAR-SHE-exercise) will visit the YMCAtwice a week (2 days apart) for 10 weeks. On the firstvisit each week they will attend a 1-h interactive GARsession (details of the session will be the same as for thecontrol groups) and 90 min of exercise and walking. Ontheir second visit each week they will attend a 1-h inter-active SHE session followed by 90 min of exercise andwalking. The exercise intervention will be offered to thecontrol group after the RCT is completed (weeks 13–24). Control groups (GAR only) will attend a 1-h inter-active GAR session at the YMCA once a week for 10weeks. Trained students will help the PI to facilitate theGAR and SHE sessions. GAR sessions will be held in thesame small, carpeted room and exercise sessions willoccur in a small gym facilitated by a fitness instructorusing a microphone and FM amplification system.GAR sessionsGAR sessions (control and intervention groups) will beguided by a modification of the GROUP program [36](http://idainstitute.com/toolbox/group/). The GROUPprogram is an IDA Institute-sponsored, web-based,interactive video-enabled program that provides a step-by-step guide for implementing and facilitating GARprograms. The guide provides instructions and informa-tional content/handouts of best practices informed byleading GAR experts along with ethnographic videosallowing facilitators to see GAR in action. In addition,an audiologist (CVB) will facilitate the GAR session onHAs and hearing assistive technology for all groups.GAR sessions will include ice-breaking activities, groundrules for participants, goal setting, multiple communica-tion strategies, coping with HL, handling difficult listen-ing situations, types and uses of hearing assistivetechnologies, local resources and “advocating for your-self and others with HL.” Psychosocial, mindfulness andstress-reduction strategies will also be included. Partici-pants will engage in practical exercises to do as a groupand at home. They will be encouraged to review theirGAR handouts with their communication partners (CPs:spouse, significant other or friend). In addition to theweekly sessions, a single 3-h session will be scheduled toinclude participants’ CPs. In this session, participantsand their communication partners will discuss their owncommunication challenges and together decide uponand practice relevant communication strategies.Socialization/health education (SHE) sessionsThe interactive SHE sessions (intervention group only)will begin with a physical activity goal-setting sessionwhile the subject matter of the remaining nine SHEsessions topic areas will be decided upon by trial partici-pant consensus. As for the WTL program [28], thesesessions will, for the most part, be developed and facili-tated by the students although some invited speakerswill facilitate sessions in their area of expertise.Exercise and walking sessionsA certified YMCA trainer will facilitate the 1-h exerciseand 30-min walking-track sessions. These sessions willfollow the standardized YMCA Fit for Life 50+ Program(https://www.h2okelowna.ca/Programs/Health-Fitness/Land-Fitness/Fit-for-Life-50?location=13ee95d3-cc67-48ca-9adb-c05d2d27fdc4) designed to build up strength,movement, coordination and balance. It incorporatesTRX™, free weights and the walking track. Participantswho miss an exercise session are asked to “make eachone up” by either attending another Fit for Life 50+ Pro-gram session or doing a set of home-based Otago FallsPrevention Program exercises [37]. Participants are alsoencouraged to walk between trial sessions and will beprovided a pedometer and tracking sheets to motivateand encourage them.The interactive GAR and SHE sessions will begin withstructured goal-setting interviews based on the model ofsocial cognitive theory of behavior change [38], motiv-ational interviewing [39] and collaborative goal setting[40]. Two to three specific, measurable, achievable, real-istic goals for both auditory and physical activity out-comes will be identified and prioritized by participants.Goal setting and attainment will be revisited at each ses-sion using the social cognitive approach to motivate, em-power and encourage adherence.MeasuresThe primary measures: feasibility outcomes and accept-ability of the pilot RCT:1. Recruitment strategies (how did participants hear ofthe trial, willingness of hearing clinics to recruitparticipants, number of potential participantscontacting the research team and by consulting thepilot trial participants, optimal ways to reach out toisolated individuals with HL)2. Recruitment rates: numbers of potential participantsthat contact the trial center; of those, how manyparticipated in telephone interview, how many gaveverbal consent, and completed functional physicalfitness testing and baseline questionnaires3. Eligibility: how many potential participants wereeligible, how many injuries, adverse events ordropouts)4. Randomization: acceptability/willingness to berandomized, how baseline measures comparedbetween groupsLambert et al. Trials  (2017) 18:47 Page 7 of 12purposesThe secondary measures: participant-specific out-comes (defined below) in order to generate estimates ofdata variation (standard deviations (SDs), standard errorof the means (SE)), 95% confidence intervals (CIs)around the differences between control and interventiongroups, and to determine the sample size estimate forthe primary outcome of the definitive RCT:1. Questionnaire measures:data collected at initial assessment include: age, sex,living situation (alone or with someone), maritalstatus, ethnicity, highest level of education, annualhousehold income before taxes, employment status,use of mobility or balance aids, falls over theprevious 3 months, and HA use2. Functional fitness measures:measures taken at initial assessment and at the endof the 10-week intervention will include a battery oftests found to be reasonable estimates of the level offitness associated with remaining physically mobileand independent in later life [41]. All assessmentswill be conducted over the 1-week period immedi-ately before and at the end of the trial at the samelocale using the same protocol and instruments.With the exception of the 6-min Walk Test(6MWT), all tests will be repeated twice for eachlimb (as appropriate) and the better of the two mea-sures will be recorded (for each limb as appropriate). Muscular endurance of the lower limbs will beassessed using the 30-s Chair Stand Test5. Session adherence and overall retention rates(intervention versus control groups’ daily sign insheets), final questionnaire completion rates anddiscontinuation rates (and reasons if given)6. Overall acceptability of the program (control versusintervention) and GAR, SHE and exercisecomponents (participant evaluation questionnaire:Likert-style and open-ended questions) What aspects need to change? What should thosechanges be and how? Acceptability of student participation in the HEand GAR sessions; capacity for student trainees –benefit to research and community? Role orimpact of older adult/student relationship mightbe something to measure in relation toloneliness… Acceptability and capacity of the YMCA to hostthe definitive RCT Cost recovery processes for the YMCA: need tofund YMCA space, staff and time for budgeting(30SCST) [42] Aerobic fitness using gait speed in a 6MWT [43] Agility and balance using the Timed Up and GoTest (TUGT) [43] Grip strength (isometric muscular strength of thehand and forearm) [44] using a Smedley handgripdynamometer (Fabrication Enterprises, Elmsford,NY, USA) The One-foot Balance Test [45] to examine bal-ance and leg strength/endurance Flexibility (lower limbs and lumbar spine) usingthe Chair Sit and Reach Test [46]; the BackScratch Test to assess the general shoulder rangeof motion [41]3. Measures of hearing and health-related quality oflife: (ICF outcomes: activities limitations, participa-tion restrictions) at initial and end of interventionwill include: The Hearing Handicap Inventory for the Elderly(HHIE-25) [47], a validated 25-item questionnaireassessing the social, emotional and psychologicalchallenges associated with HL and correlates wellwith audiometrically measured moderate to se-vere HL The RAND SF-36 [48] (ICF outcomes: physicalfunction, activities limitations, participation re-strictions, a 36-item health-related quality of lifemeasure with eight subscales including physicalfunctioning, role functioning, bodily pain, generalhealth, vitality, mental health, emotional role limi-tation and social functioning and social support4. Measures of loneliness and social connectedness atinitial and end of intervention: De Jong-Gierveld Loneliness Scale [49]) Social participation using eight items developedfor the Canadian Community Health Survey 4.2[50], to determine the frequency of participationin family, friendship, and activities with otherpeople outside of the household Availability of social support using the MedicalOutcomes Trial-Social Support Survey [51], a val-idated scale of overall social support and four do-mains of social support (emotional/informational,tangible, affectionate and positive interactions) The Geriatric Depression Scale, a15-item ques-tionnaire used as a screening tool in the olderpopulation [52]5. Blood pressure and heart rate (initially and at end ofintervention) according to Canadian HypertensionEducation Program guidelines [53] using thevalidated BPM-100 (BpTRU Medical Devices, Coqui-tlam, BC, Canada), an automated oscillometric non-invasive blood pressure monitorMeasures taken at the end of the trial.6. GAR evaluation: at end of intervention. TheInternational Outcomes Inventory-AlternativeLambert et al. Trials  (2017) 18:47 Page 8 of 12Interventions (IOI-AI) [54] questionnaire to deter-mine outcomes of GAR programs. A modified ClientOriented Scale of Improvement (COSI) question-naire [26] to evaluate the extent to which individualgoals were reached [55] and overall benefit of theGAR interventionSerious adverse eventsThe trial is expected to be low risk for serious adverseevents, such as cardiovascular events (myocardial infarc-tion, stroke, etc.), given the validated PARQ+ screenand/or the provision of a physician signed letter of “ex-ercise readiness.” While the risk is low, there is a possi-bility of a fall and or fracture during the supervisedexercise sessions. This risk will be minimized with exer-cise sessions facilitated by Canadian Society for ExercisePhysiology (CSEP) certified fitness trainers. If an adverseevent does occur, the PI (clinical team member onsiteduring all session times) and key YMCA staff will be im-mediately alerted and, research protocols and instituteappropriate procedures initiated and changes to the ex-ercise program implemented if deemed necessary.Sample sizeThe sample size for this pilot trial [56, 57] is based uponanticipated numbers of potential participants who con-tact the trial center within an 8-week recruitmentperiod. Based on previous unpublished experience in theWTL program using pre-post data on older adults withHL, we estimate that approximately 15 per week willcontact the trial center, 50–60% of those who make ini-tial contact will meet the eligibility criteria and agree tobe randomized, and at least 23 people per group at trialend to show a clinically meaningful average increase inthe Sit to Stand Test (STS) of 2 [58]. This sample sizewill also ensure that enough data is available to generatereliable SE, SD and 95% CI on the sample size requiredfor the large RCT with this measure as the primary out-come. A definitive RCT will be deemed feasible when atleast 120 individuals contact the pilot trial center, ≥90%fulfill feasibility outcomes 2–4 and at least 70% of ran-domized participants fulfill outcome number 5. A largerRCT will be deemed acceptable if at least 85% of partici-pants find the GAR, exercise and SHE sessions highlyacceptable or acceptable.Research data and managementParticipants will be assigned a participant number uponinitial contact with the trial coordinator. Questionnaireand functional fitness testing data will be collected and re-corded by the trained research team members on paper-based data collection sheets during the week prior torandomization and during the week after the end of the10-week trial. Fully anonymized data will be manuallyentered into an Excel® spreadsheet, 100% double-checkedfor errors or omissions by a team member blinded to theparticipants’ group allocation, then cleaned and trans-ferred into Stata® statistical software for analysis.Statistical methodsFor primary outcome measures, analyses will be descrip-tive and variables will be expressed as frequency andpercentage for all data relating to recruitment, adher-ence, overall retention rates, plus all other categoricaldata on program feasibility and acceptability. Any con-tinuous data will be expressed as mean plus SD or me-dian and interquartile range (for non-normal data).Participant demographics at baseline will be describedboth by group and overall sample. Responses for Likert-type data will be combined into three nominal categories(“strongly agree/agree,” “strongly disagree/disagree” and“don’t know”) and differences between the interventionand control groups analyzed by Fisher’s exact test [59].Responses to open-ended questions will be coded andorganized into themes and descriptive statistics (includ-ing percentages) will be used to report the results.For secondary outcomes measures, the main analysiswill be intention-to-treat: the group to which a participantis assigned will be the group in which they are analyzed,regardless of participant protocol violations, attendancerate or dropout [60]. Last observation carried forward willbe used to impute missing outcome data assuming lessthan 20% missing data for a given outcome measure. Thefunctional fitness measures will be analyzed using the ana-lysis of covariance method with the baseline measure asthe covariate and follow-up measure as the outcome [61].Data will be transformed for analysis of covariance wheninitial and end of intervention data is non-normal. Both acomplete case and per protocol analysis will also be con-ducted to study the impact of departures from the as-sumptions made in the main intention-to-treat analysis.All continuous primary and secondary outcome variableswill be assessed for normality visually using histogramsand boxplots, with the Shapiro-Wilk test used as a supple-ment to the graphical assessment.Knowledge translationOverall knowledge translation goals will be to increasepublic and academic awareness of HL as a disability andthe need for organized screening initiatives and enhancedprograming to support all five ICF domains of disability inolder adults with HL. Results will be presented to partici-pants, families and significant others/supports, study part-ners, at public forums, at local, national and internationaluniversity academic and health conferences, to health andnon-health-related governmental departments and media(radio, local TV). Articles will be published in local news-papers and peer-reviewed academic journals.Lambert et al. Trials  (2017) 18:47 Page 9 of 12DiscussionHL affects well over half of older adults in Canada and isunder-recognized, undertreated and associated with psy-chosocial and cognitive decline, increased falls, hospitaliza-tions and premature mortality. If successful, disseminationof this unique program may ultimately be associated withsignificant improvements in the health and wellbeing ofolder adults with HL. The trial will help to determine thefeasibility and acceptability of this program and provides aparticipatory approach to a detailed intervention plan andsample size considerations for a larger validation RCT. Theaim of this pilot trial is to better understand how to accessand recruit older adults with HL and how to improve theirhearing and health-related quality of life. The unique aspectof this trial is the potential for this intervention to addressall five ICF domains of disability by providing access to theenvironment (YMCA), to support personal factors (infor-mation, communication strategies, socialization, goal set-ting, motivational peer support) that are the foundationsfor improvements in the physical and psychosocial aspectsof activity limitations and participation restrictions. Specif-ically, the trial will help to understand the potential of thisprogram to improve functional fitness and the psychosocialdeclines associated with HL.The functional fitness outcome measures were chosenspecifically because of their validated [41] relationship tothe maintenance of physical independence for olderadults: one of the future large RCT’s main goals. Becauseof the well-recognized challenges in evaluating GAR out-comes [62], multiple assessment tools were used. For ex-ample, the HHIE-25 may not be a sensitive tool toassess some of the emotional/psychosocial changes thata generic quality of life/health scale such as the RANDSF-36 might be. On the other hand, the RAND SF-36does very little to assess HL-related issues [62]. Use ofthe HHIE-25, COSI and IOI-A may provide a more glo-bal assessment. Furthermore, because one or more ofthese scales is commonly used in other studies, our datawill likely be more readily comparable the other studies.Measurement of loneliness, isolation and social connect-edness are also fraught with challenges. It is hypothe-sized that use of validated scales, especially ones with anextended track record of use in older adult populations[49] or linked to longitudinal health measures surveys,such as the Canadian Community Health Survey, willprovide a reasonably valid assessment of change.Walk, Talk ‘n’ Listen will use a modification of theOtago exercise program that has been associated with30–35% reductions in falls and fall-related injuries andhospitalizations in the elderly [37]. Along with address-ing risk factors for falls, WTListen emphasizes healthylifestyles, socialization, empowerment in addition to op-timizing the hearing and communication of participantsthrough GAR. As such, WTListen has the potential forsignificant improvements in quality of life, functional fit-ness and health and in health care dollar savings. Part-nering with the YMCA and interdisciplinary studentinvolvement helps to keep expenses down, provides for arich interdisciplinary community service learning andleadership experience, provides both participants andstudents with a unique intergenerational experience andprovides a vehicle to sustain the program (the WTL pro-gram is currently being incorporated into the commu-nity service learning curriculum of the UBC SouthernMedical Program and integrated with ongoing YMCAprograming). While there is research on the disability in-curred by those with HL and their family members,there is a paucity of interventions addressing the func-tional physical fitness ICF domain. This may be an im-portant new area of research into overcoming some ofthe barriers to a complete and satisfying life in olderadults with HL.There are limitations to this pilot trial. It is not knownhow readily participants will step forward to participatein the trial. Aside from the well-known reasons for de-clining participation in research studies, such as lack oftime, mobility challenges, lack of awareness of the trialand the desire not to be randomized into a controlgroup, we expect that the presence of HL itself to be abarrier to participation. Older adults experiencing HLmay be reluctant to participate in group activities by na-ture of the effect of their HL on activity and participa-tion limitations especially in group situations. Inaddition, there is evidence of a link between specific at-titudinal beliefs and help-seeking behavior in adults withHL [63] such as perceived lack of severity of their HL,perceived lack of benefit from the clinical trial andperceived lack of self-efficacy. Furthermore, while partic-ipants are not obligated to provide reasons for nonad-herence or declining participation, we will attempt tosecure this information while adhering to standard eth-ical guidelines. Due to unforeseen circumstances, someof the team members collecting functional fitness dataat the end of the trial may not be blinded as to the par-ticipants’ allocation to control or intervention group.This will be mitigated in part by assuring that thoseteam members are not assigned to the primary outcomefitness assessments. Additionally, since the PI (CAJ) willbe delivering the GAR and SHE sessions and will not beblinded to the participants’ group allocation, she will notperform any primary outcome fitness assessments.Blinding of outcome assessments will be of primary im-portance in the larger RCT. While the YMCA is highlyaccessible, transportation challenges may be an issue forsome potential participants. Despite the fact that olderadult peers with HL essentially designed the program,there may be other unrecognized factors (that we hopeto uncover) that may preclude participation.Lambert et al. Trials  (2017) 18:47 Page 10 of 12Strengths of the pilot trial design include the fact thatthe protocol was developed collaboratively with olderadults who have HL. Thus, it is likely to be more suitedto the needs and comfort level of those with HL and,therefore, be more acceptable to them.This pilot project will generate information about thefeasibility, acceptability and the implementation of a novelcommunity-based group intervention aimed at reducingthe downstream effects of HL among older adults. Thisknowledge will help to increase awareness of the plight ofolder adults with HL. This innovative and timely trial willbe the first to provide early evidence for the possible bene-fits of combining socialization, health education and func-tional fitness training as an approach to addressing majorhealth care gaps in the holistic management of HL [64]and will help to inform necessary changes in health carescreening, practice and policy.Trial statusRecruitment started in March 2016 and is ongoing until26 September 2016.Additional fileAdditional file 1: CONSORT checklist for pilot trials. (DOCX 46 kb)AbbreviationsAR: Audiological rehabilitation; CP: Communication partner; GAR: Groupaudiological rehabilitation; HA: Hearing aid; HE: Health education;HHIE: Hearing Handicap Inventory for the Elderly; HL: Hearing loss;HRQOL: Health-related quality of life; ICF: International Classification ofFunctioning, Disability and Health; UBCO: University of British Columbia,Okanagan campus, Kelowna, BC, Canada; WHO: World Health Organization;WTL: Walk and Talk for Your Life; WTListen: Walk, Talk ‘n’ ListenAcknowledgementsNot applicable.This protocol is reported according to the CONSORT 2010 Statement:extension to randomized pilot and feasibility trials [65].FundingDevelopment of the trial protocol was funded by the Peter Wall Institute forAdvanced Studies (Project grant No: 20R22510 Fas No. F14-03310) ubcpwal-g-solutions@mail.ubc.ca. The funding body played no role in the design ofthe trial and collection, analysis and interpretation of data and in writing themanuscript.Availability of data and materialsThe datasets during and/or analyzed during the current trial available fromthe corresponding author on reasonable request.Authors’ contributionsPM and CAJ conceived the trial and are the reference clinicians for the trial. CAJ isthe PI and drafted the manuscript along with medical students JL, R G-T KK, MJand our statistician, JS. GJ and JL (reference human kinetics experts) providedinput on the functional fitness testing. HM and MAM reference psychologist andsocial work representatives) and PM provided input on the psychosocial measures.KK and CAJ adapted the GROUP online auditory rehabilitation program into a10-module Power Point ® toolkit. KVB delivered a session on auditory anatomy,the physiology of hearing loss and assistive technologies. All authors contributedto critically reviewing and revising the manuscript. All authors read and approvedthe final manuscript for publication.Competing interestsThe authors declare that they have no competing interests except that VB isan audiologist owner of a NexGen Hearing Aid Clinic.Consent for publicationNot applicable.Ethics approval and consent to participateEthical approval for this trial was obtained from the University of British ColumbiaOkanagan Research Services Behavioural Research Ethics Board. Certificate ofapproval – minimal risk UBC BREB number: H15-02319. Potential participants willundergo verbal consent prior to preliminary telephone eligibility. Those meetingpreliminary eligibility requirements will sign full written consent prior to finaleligibility assessment and randomization.Author details1Faculty of Medicine, Southern Medical Program, University of BritishColumbia, Okanagan campus, Kelowna, BC, Canada. 2Faculty of Medicine,Department of Surgery, Division of Otolaryngology, University of BritishColumbia, Okanagan campus, Kelowna, BC, Canada. 3Faculty of Health andSocial Development, School of Health and Exercise Science, University ofBritish Columbia, Okanagan campus, Kelowna, BC, Canada. 4Irving K. BarberSchool of Arts and Social Sciences, Psychology, University of BritishColumbia, Okanagan campus, Kelowna, BC, Canada. 5Audiologist, NexGenHearing, Kelowna, BC, Canada. 6Faculty of Health and Social Development,School of Nursing, University of British Columbia, Okanagan campus,Kelowna, BC, Canada. 7Irving K. Barber School of Arts and Social Sciences,Sociology and School of Social Work, University of British Columbia,Okanagan campus, Kelowna, BC, Canada. 8Southern Medical Program, #321Reichwald Health Sciences Center, 1088 Discovery Ave, Kelowna, BC V1V-1V7,Canada.Received: 11 August 2016 Accepted: 10 January 2017References1. World Health Organization. International Classification of Functioning,Disability and Health (ICF). Geneva: World Health Organization; 2001.2. Lin FR, Niparko JK, Ferrucci L. Hearing loss prevalence in the United States.Arch Intern Med. 2011;171(20):1851–2.3. Statistics Canada. Hearing loss of Canadians, 2012 to 2015. Ottawa: StatisticsCanada; 2016.4. Gopinath B, Schneider J, Hickson L, McMahon CM, Burlutsky G, Leeder SR,Mitchell P. Hearing handicap, rather than measured hearing impairment,predicts poorer quality of life over 10 years in older adults. Maturitas. 2012;72(2):146–51.5. Chia EM, Wang JJ, Rochtchina E, Cumming RR, Newall P, Mitchell P. 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