Background
Conceptual framework
Methods
Trial design
Trial population and randomization
Preliminary telephone eligibility assessment
Inclusion criteria | Exclusion criteria |
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1. Aged 65 years or older 2. English speaking 3. Able to sign written informed consent 4. Hearing Handicap in the Elderly (HHIE-25) score of >17 [47] or a previous diagnosis of HL 5. Clearance to safely partake in the trial’s physical activities: PARQ+ (Physical Activity Readiness Questionnaire [66]) or written physician clearance for participation 6. Moderate functional fitness: gait speed >0.72 and <1.8 m/s [67] and/or 30-s STS ≥6 and <21 (within or below published sex- and age-adjusted average levels) | 1. Unable to ambulate/walk for exercise 2.Serious illness limiting their ability to exercise or complete the trial 3. Contraindications to exercise: failure to fulfill the prerequisites of the PARQ+ 4. Uncontrolled hypertension (≥160/>90 mmHg) 5. Signs or symptoms of alcohol or substance dependence 6. Refusal to be randomized 7. Lack of transportation to the trial 8. Unable to commit to attending 80% or more of the sessions |
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Self-report less than 150 min per week of physical activity [33]
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Have not participated in any organized exercise program for at least 6 months
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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
Randomization
Research team development
Intervention
GAR sessions
Socialization/health education (SHE) sessions
Exercise and walking sessions
Measures
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What aspects need to change? What should those changes be and how?
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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…
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Acceptability and capacity of the YMCA to host the definitive RCT
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Cost recovery processes for the YMCA: need to fund YMCA space, staff and time for budgeting purposes
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Muscular endurance of the lower limbs will be assessed using the 30-s Chair Stand Test (30SCST) [42]
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Aerobic fitness using gait speed in a 6MWT [43]
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Agility and balance using the Timed Up and Go Test (TUGT) [43]
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Grip strength (isometric muscular strength of the hand and forearm) [44] using a Smedley handgrip dynamometer (Fabrication Enterprises, Elmsford, NY, USA)
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The One-foot Balance Test [45] to examine balance and leg strength/endurance
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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
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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
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De Jong-Gierveld Loneliness Scale [49])
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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
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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)
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The Geriatric Depression Scale, a15-item questionnaire used as a screening tool in the older population [52]