Abstract
BackgroundHearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of this pilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improve functional fitness, social connectedness, hearing and health-related quality of life in older adults with HL.MethodsThis 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample of ambulatory adults aged 65 years or older with self-reported HL. Following baseline assessments, participants will be randomized to either intervention (exercise, health education, socialization and group auditory rehabilitation (GAR)) or control (GAR only) groups. The intervention group will attend a local YMCA twice a week and the control group once a week. Intervention sessions will include 45 min of strengthening, balance and resistance exercises, 30 min of group walking at a self-selected pace and 60 min of interactive health education or GAR. The control group will attend 60-min GAR 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 to Stand Test), hearing and health-related quality of life, loneliness, depression, social participation and social support. At trial end, feasibility (recruitment, randomization, retention, acceptability) and GAR will be evaluated.DiscussionDespite evidence suggesting that HL is associated with declines in functional fitness, there are no studies aimed at addressing functional fitness declines associated with the disability of HL. This pilot trial will provide knowledge about the physical, mental and social impacts on health related to HL as a disability. This will inform the feasibility of a larger RCT and preliminary evidence about the initial effects of a novel, community-based, holistic intervention addressing both the negative psychosocial and functional physical effects of HL among older adults.Trial registrationClinicalTrials.gov, NCT02662192. Registered on 14 January 2016
Highlights
Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality
In partnership with the Young Men’s Christian Association (YMCA) of Okanagan, the aim of this pilot randomized controlled trial (RCT) is two-fold: (1) to explore the feasibility and acceptability of the novel WTListen intervention for older adults with HL and (2) to provide preliminary information about the research question: In older adults with HL, what effect does a group exercise and socialization/health education intervention added to group auditory rehabilitation (GAR) have on: (a) body function impairments: and activity limitations and participation restrictions and (b) perceptions of loneliness and social network?
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
Summary
Trial design In this single-blind, randomized controlled pilot trial, 60 ambulatory adults aged 65 years or older, with selfreported HL will be randomized into either the WListen intervention group (exercise, SHE sessions and GAR) or the control group (GAR alone) (see Fig. 2 and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist (Additional file 1) and the SPIRIT figure (Fig. 3)). 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 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. Articles will be published in local newspapers and peer-reviewed academic journals
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