Study for Rural Innovations in the Delivery of Exercise

Study Overview
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Brief Summary
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: Falls are the primary cause of injury and a leading cause of disability and mortality among older adults. Risk factors for falling are common among older adults with knee osteoarthritis (OA) - a highly prevalent condition. Physical exercise is consistently the most efficacious intervention for preventing falls in older adults. However, access to these programs is severely limited in rural settings. Considering that rural communities have a higher disease burden and higher proportion of older adults than non-rural areas, there is a critical need to (1) adapt evidence-based exercise programs for remote delivery to increase access for rural older adults and (2) develop pathways to implement exercise programs in rural health care systems that consistently reach and engage patients with knee OA. Accordingly, the proposed project aims to refine a protocol for remote delivery of Enhance Fitness (EF). EF is an evidence-based, group exercise program involving strength, endurance, and balance training that is recommended for falls prevention and OA management

Official Title
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Adapting an Evidence-Based Exercise Program for Remote Delivery to Rural Older Adults

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Tele-Enhance Fitness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community-dwelling English-speaking Physician diagnosed knee osteoarthritis Knee pain that occurs almost daily for at least the past 3 months and is moderate to severe in intensity Knee pain-related difficulty with walking or climbing stairs resident of a rural county Exclusion Criteria: cognitive impairment determined by a Mini Montreal Cognitive Assessment score of <11 any of the following in the past 6 months: cancer requiring treatment (except for non- melanoma skin cancer), heart attack, stroke, hip fracture, hip/knee replacement, spinal surgery, heart surgery, deep vein thrombosis, or pulmonary embolus; and temporary exclusions hospitalization within the last month ≥3 falls within the past month

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-EF<br>Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training | Behavioral: Tele-Enhance Fitness<br>* Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and Acceptability of Tele-Enhance Fitness | Feasibility outcomes include intervention engagement and adherence, retention, fidelity of tele-EF treatment, and adverse events. Multiple dimensions of acceptability will be assessed from qualitative interviews with participants and instructors. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 8-item Short Form | Patient-reported physical functioning | Change from baseline PROMIS physical function score at 12 weeks | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) Physical Function Subscale | Patient-reported knee pain-related interference with physical functioning | Change from Baseline KOOS Physical Function Subscale score at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Rural, Older Adults