Targeting Functional Fitness, Hearing and Health-Related Quality of Life in Older Adults With Hearing Loss. Walk, Talk and Listen for Your Life, A Randomized Controlled Trial
Phase: NA
Conditions: Hearing Loss, Functional
Sponsor: University of British Columbia

Cover page for: 
Walk, Talk and Listen: a pilot 
randomized controlled trial targeting 
functional fitness and loneliness in 
older adults with hearing loss 
 
NCT number: NCT 20662192 
Date of ethical approval: October 8, 2015 
 
 
 
 
 
Study protocol and statistical analysis plan. 
 
 
 
 
 
 
 
 
 
 
 
 

In this single-blind, randomized controlled pilot trial, 60 ambulatory adults aged 65 years or 
older, with self-reported HL will be randomized into either the WListen intervention group 
(exercise, SHE sessions and GAR) or the control group (GAR alone). Control-group participants 
will be asked not to change their current physical activity levels and will be offered the 10-week 
exercise component after the trial is complete. The trial will take place in the “real life” context 
of a local sports and recreation facility (YMCA Okanagan) and will be free of charge to all 
participants. Interactive GAR and SHE sessions will be small, closed groups of no more than 12 
participants and facilitated for the most part by CAJ and KK. An audiologist (KVB) will deliver 
a GAR session on the anatomy and process of HL and hearing assistive technologies. This trial 
will examine recruitment efficacy, reasons for participant interest in joining the trial, attrition 
rates and reasons, acceptability of GAR, SHE and physical activity interventions along with 
changes in the functional fitness and psychosocial measures relative to the control group. The 
findings will inform the design of a larger, multisite RCT. 
Trial population and randomization 
Ambulatory, community-dwelling adults aged 65 years or older will be invited to participate 
either directly by their audiologist, or through posters and information sheets placed in 10 
Kelowna audiologists’ offices, otolaryngologists’ offices, local seniors’ venues, the YMCA, 
local non-profit seniors’ agency newsletters and local newspaper ads. Potential participants who 
call the trial telephone number will be given information by the trial coordinator (TC: CR) about 
the trial and, if still interested, will undergo a preliminary telephone eligibility assessment. 
Preliminary telephone eligibility assessment 
Table 1 provides the detailed inclusion and exclusion criteria. The trial coordinator, the principle 
investigator (PI: CAJ), will verbally review the Consent Form with potential participants and 
answer any questions that arise.. After verbal consent is obtained, participants will be again 
asked, “Do you have difficulty hearing when conversing with another person in a noisy 
environment?” [30]. Those answering “yes” will be guided through the validated Physical 
Activity Readiness Questionnaire (PARQ+) [31] to confirm that they meet the inclusion criteria 
and are healthy enough to participate in the intervention without exacerbating any existing 
symptomatology [32]. Those who pass the initial PARQ+ screen and/or those who provide a 
physician-signed CSEP letter of “exercise readiness” and: 
• 
Self-report less than 150 min per week of physical activity [33] 
• 
Have not participated in any organized exercise program for at least 6 months 
• 
Are available and willing to attend at least 80% of the 10-week sessions in addition to 
completing baseline and final assessments, will be invited for final eligibility assessment 
 
 

Final eligibility assessment 
Final eligibility assessment (functional fitness testing) and baseline questionnaire completion 
will take place at the trial site (a local YMCA site) and be performed by members of the trained 
research team after signed informed consent has been obtained. 
Randomization 
Participants will be randomized (Stata® (StataCorp. 2013. Stata Statistical Software: Release 13, 
College Station, TX, USA: StataCorp LP) by an independent statistician (JS) into two groups, 
using permuted blocks of random sizes, stratifying on gender and age (below 73 years/73+ years) 
to ensure even distribution of these variables. The block sizes will not be disclosed to ensure 
concealment [34, 35]. When either of a couple is randomized to a different group (one to the 
control group and one to the intervention group), a fair coin toss will be used to decide which 
group they will both be assigned to (heads = control; tails = intervention). The randomization 
sequence will be concealed from the researchers who will confirm consent and eligibility with 
participants before allocation is revealed. Participants will be enrolled and assigned to the time 
and day(s) of the week by the project coordinator in consideration of their personal schedules. It 
is not feasible to mask participants or researchers after group allocation as the intervention 
includes an exercise program and the control does not. 
Research team development 
The research team will include the PI, the PC, two to four students per semester and their faculty 
supervisors (CAJ, HM, DK, GJ, JL, M-AM) from medicine, psychology, nursing, human 
kinetics and social work, respectively. This research team will be responsible for pre-and post-
intervention assessments and training students and staff to conduct sessions in either the 
intervention or the control group. 
Intervention 
The trial will occur at different times on the same days for the intervention and the control 
groups. The intervention groups (GAR-SHE-exercise) will visit the YMCA twice a week (2 days 
apart) for 10 weeks. On the first visit each week they will attend a 1-h interactive GAR session 
(details of the session will be the same as for the control groups) and 90 min of exercise and 
walking. On their second visit each week they will attend a 1-h interactive SHE session followed 
by 90 min of exercise and walking. The exercise intervention will be offered to the control group 
after the RCT is completed (weeks 13–24). Control groups (GAR only) will attend a 1-h 
interactive GAR session at the YMCA once a week for 10 weeks. Trained students will help the 
PI to facilitate the GAR and SHE sessions. GAR sessions will be held in the same small, 
carpeted room and exercise sessions will occur in a small gym facilitated by a fitness instructor 
using a microphone and FM amplification system. 
 

GAR sessions 
GAR sessions (control and intervention groups) will be guided by a modification of the GROUP 
program [36] (http://idainstitute.com/toolbox/group/). The GROUP program is an IDA Institute-
sponsored, web-based, interactive video-enabled program that provides a step-by-step guide for 
implementing and facilitating GAR programs. The guide provides instructions and informational 
content/handouts of best practices informed by leading GAR experts along with ethnographic 
videos allowing facilitators to see GAR in action. In addition, an audiologist (CVB) will 
facilitate the GAR session on HAs and hearing assistive technology for all groups. GAR sessions 
will include ice-breaking activities, ground rules for participants, goal setting, multiple 
communication strategies, coping with HL, handling difficult listening situations, types and uses 
of hearing assistive technologies, local resources and “advocating for yourself and others with 
HL.” Psychosocial, mindfulness and stress-reduction strategies will also be included. Participants 
will engage in practical exercises to do as a group and at home. They will be encouraged to 
review their GAR handouts with their communication partners (CPs: spouse, significant other or 
friend). In addition to the weekly sessions, a single 3-h session will be scheduled to include 
participants’ CPs. In this session, participants and their communication partners will discuss their 
own communication challenges and together decide upon and practice relevant communication 
strategies. 
Socialization/health education (SHE) sessions 
The interactive SHE sessions (intervention group only) will begin with a physical activity goal-
setting session while the subject matter of the remaining nine SHE sessions topic areas will be 
decided upon by trial participant consensus. As for the WTL program [28], these sessions will, 
for the most part, be developed and facilitated by the students although some invited speakers 
will facilitate sessions in their area of expertise. 
Exercise and walking sessions 
A certified YMCA trainer will facilitate the 1-h exercise and 30-min walking-track sessions. 
These sessions will follow 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 incorporates TRX™, free weights and the walking track. 
Participants who miss an exercise session are asked to “make each one up” by either attending 
another Fit for Life 50+ Program session or doing a set of home-based Otago Falls Prevention 
Program exercises [37]. Participants are also encouraged to walk between trial sessions and will 
be provided a pedometer and tracking sheets to motivate and encourage them. 
The interactive GAR and SHE sessions will begin with structured goal-setting interviews based 
on the model of social cognitive theory of behavior change [38], motivational interviewing [39] 
and collaborative goal setting [40]. Two to three specific, measurable, achievable, realistic goals 
for both auditory and physical activity outcomes will be identified and prioritized by participants. 
Goal setting and attainment will be revisited at each session using the social cognitive approach 
to motivate, empower and encourage adherence. 

Measures 
The primary measures: feasibility outcomes and acceptability of the pilot RCT: 
1. Recruitment strategies (how did participants hear of the trial, willingness of hearing 
clinics to recruit participants, number of potential participants contacting the research 
team and by consulting the pilot trial participants, optimal ways to reach out to isolated 
individuals with HL) 
2. Recruitment rates: numbers of potential participants that contact the trial center; of those, 
how many participated in telephone interview, how many gave verbal consent, and 
completed functional physical fitness testing and baseline questionnaires 
3. Eligibility: how many potential participants were eligible, how many injuries, adverse 
events or dropouts) 
4. Randomization: acceptability/willingness to be randomized, how baseline measures 
compared between groups 
5. Session adherence and overall retention rates (intervention versus control groups’ daily 
sign in sheets), final questionnaire completion rates and discontinuation rates (and 
reasons if given) 
6. Overall acceptability of the program (control versus intervention) and GAR, SHE and 
exercise components (participant evaluation questionnaire: Likert-style and open-ended 
questions) 
• 
What aspects need to change? What should those changes be and how? 
• 
Acceptability of student participation in the HE and GAR sessions; capacity for 
student trainees – benefit to research and community? Role or impact of older 
adult/student relationship might be something to measure in relation to 
loneliness… 
• 
Acceptability and capacity of the YMCA to host the definitive RCT 
• 
Cost recovery processes for the YMCA: need to fund YMCA space, staff and 
time for budgeting purposes 
The secondary measures: participant-specific outcomes (defined below) in order to generate 
estimates of data variation (standard deviations (SDs), standard error of the means (SE)), 95% 
confidence intervals (CIs) around the differences between control and intervention groups, and to 
determine the sample size estimate for the primary outcome of the definitive RCT: 
1. Questionnaire measures: 
data collected at initial assessment include: age, sex, living situation (alone or with 
someone), marital status, ethnicity, highest level of education, annual household income 
before taxes, employment status, use of mobility or balance aids, falls over the previous 3 
months, and HA use 
2. Functional fitness measures: 

measures taken at initial assessment and at the end of the 10-week intervention will 
include a battery of tests found to be reasonable estimates of the level of fitness 
associated with remaining physically mobile and independent in later life [41]. All 
assessments will be conducted over the 1-week period immediately before and at the end 
of the trial at the same locale using the same protocol and instruments. With the 
exception of the 6-min Walk Test (6MWT), all tests will be repeated twice for each limb 
(as appropriate) and the better of the two measures will be recorded (for each limb as 
appropriate). 
• 
Muscular endurance of the lower limbs will be assessed using the 30-s Chair 
Stand Test (30SCST) [42] 
• 
Aerobic fitness using gait speed in a 6MWT [43] 
• 
Agility and balance using the Timed Up and Go Test (TUGT) [43] 
• 
Grip strength (isometric muscular strength of the hand and forearm) [44] using a 
Smedley handgrip dynamometer (Fabrication Enterprises, Elmsford, NY, USA) 
• 
The One-foot Balance Test [45] to examine balance and leg strength/endurance 
• 
Flexibility (lower limbs and lumbar spine) using the Chair Sit and Reach Test 
[46]; the Back Scratch Test to assess the general shoulder range of motion [41] 
3. Measures of hearing and health-related quality of life: (ICF outcomes: activities 
limitations, participation restrictions) at initial and end of intervention will include: 
• 
The Hearing Handicap Inventory for the Elderly (HHIE-25) [47], a validated 25-
item questionnaire assessing the social, emotional and psychological challenges 
associated with HL and correlates well with audiometrically measured moderate 
to severe HL 
• 
The RAND SF-36 [48] (ICF outcomes: physical function, activities limitations, 
participation restrictions, a 36-item health-related quality of life measure with 
eight subscales including physical functioning, role functioning, bodily pain, 
general health, vitality, mental health, emotional role limitation and social 
functioning and social support 
4. Measures of loneliness and social connectedness at initial and end of intervention: 
• 
De Jong-Gierveld Loneliness Scale [49]) 
• 
Social participation using eight items developed for the Canadian Community 
Health Survey 4.2 [50], to determine the frequency of participation in family, 
friendship, and activities with other people outside of the household 
• 
Availability of social support using the Medical Outcomes Trial-Social Support 
Survey [51], a validated scale of overall social support and four domains of social 
support (emotional/informational, tangible, affectionate and positive interactions) 
• 
The Geriatric Depression Scale, a15-item questionnaire used as a screening tool in 
the older population [52] 

5. Blood pressure and heart rate (initially and at end of intervention) according to Canadian 
Hypertension Education Program guidelines [53] using the validated BPM-100 (BpTRU 
Medical Devices, Coquitlam, BC, Canada), an automated oscillometric noninvasive 
blood pressure monitor 
Measures taken at the end of the trial. 
6. GAR evaluation: at end of intervention. The International Outcomes Inventory-
Alternative Interventions (IOI-AI) [54] questionnaire to determine outcomes of GAR 
programs. A modified Client Oriented Scale of Improvement (COSI) questionnaire [26] 
to evaluate the extent to which individual goals were reached [55] and overall benefit of 
the GAR intervention 
Serious adverse events 
The trial is expected to be low risk for serious adverse events, such as cardiovascular events 
(myocardial infarction, stroke, etc.), given the validated PARQ+ screen and/or the provision of a 
physician signed letter of “exercise readiness.” While the risk is low, there is a possibility of a 
fall and or fracture during the supervised exercise sessions. This risk will be minimized with 
exercise sessions facilitated by Canadian Society for Exercise Physiology (CSEP) certified 
fitness trainers. If an adverse event does occur, the PI (clinical team member onsite during all 
session times) and key YMCA staff will be immediately alerted and, research protocols and 
institute appropriate procedures initiated and changes to the exercise program implemented if 
deemed necessary. 
Sample size 
The sample size for this pilot trial [56, 57] is based upon anticipated numbers of potential 
participants who contact the trial center within an 8-week recruitment period. Based on previous 
unpublished experience in the WTL program using pre-post data on older adults with HL, we 
estimate that approximately 15 per week will contact the trial center, 50–60% of those who make 
initial contact will meet the eligibility criteria and agree to be randomized, and at least 23 people 
per group at trial end to show a clinically meaningful average increase in the Sit to Stand Test 
(STS) of 2 [58]. This sample size will also ensure that enough data is available to generate 
reliable SE, SD and 95% CI on the sample size required for the large RCT with this measure as 
the primary outcome. A definitive RCT will be deemed feasible when at least 120 individuals 
contact the pilot trial center, ≥90% fulfill feasibility outcomes 2–4 and at least 70% of 
randomized participants fulfill outcome number 5. A larger RCT will be deemed acceptable if at 
least 85% of participants find the GAR, exercise and SHE sessions highly acceptable or 
acceptable. 
Research data and management 
Participants will be assigned a participant number upon initial contact with the trial coordinator. 
Questionnaire and functional fitness testing data will be collected and recorded by the trained 
research team members on paper-based data collection sheets during the week prior to 
randomization and during the week after the end of the 10-week trial. Fully anonymized data will 

be manually entered into an Excel® spreadsheet, 100% double-checked for errors or omissions 
by a team member blinded to the participants’ group allocation, then cleaned and transferred into 
Stata® statistical software for analysis. 
Knowledge translation 
Overall knowledge translation goals will be to increase public and academic awareness of HL as 
a disability and the need for organized screening initiatives and enhanced programing to support 
all five ICF domains of disability in older adults with HL. Results will be presented to 
participants, families and significant others/supports, study partners, at public forums, at local, 
national and international university academic and health conferences, to health and non-health-
related governmental departments and media (radio, local TV). Articles will be published in 
local newspapers and peer-reviewed academic journals. 
Statistical methods 
For primary outcome measures, analyses will be descriptive and variables will be expressed as 
frequency and percentage for all data relating to recruitment, adherence, overall retention rates, 
plus all other categorical data on program feasibility and acceptability. Any continuous data will 
be expressed as mean plus SD or median and interquartile range (for non-normal data). 
Participant demographics at baseline will be described both 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 
intervention and control groups analyzed by Fisher’s exact test [59]. Responses to open-ended 
questions will be coded and organized into themes and descriptive statistics (including 
percentages) will be used to report the results. 
For secondary outcomes measures, the main analysis will be intention-to-treat: the group to 
which a participant is assigned will be the group in which they are analyzed, regardless of 
participant protocol violations, attendance rate or dropout [60]. Last observation carried forward 
will be used to impute missing outcome data assuming less than 20% missing data for a given 
outcome measure. The functional fitness measures will be analyzed using the analysis of 
covariance method with the baseline measure as the covariate and follow-up measure as the 
outcome [61]. Data will be transformed for analysis of covariance when initial and end of 
intervention data is non-normal. Both a complete case and per protocol analysis will also be 
conducted to study the impact of departures from the assumptions made in the main intention-to-
treat analysis. All continuous primary and secondary outcome variables will be assessed for 
normality visually using histograms and boxplots, with the Shapiro-Wilk test used as a 
supplement to the graphical assessment. 
 
 
 
 
 

 
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