Study for Rural Innovations in the Delivery of Exercise

Not Applicable

• Conditions: Knee Osteoarthritis
• Interventions: Behavioral: Tele-Enhance Fitness

• Registration Number: NCT04881864
• Lead Sponsor: University of Washington

Brief Summary

: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-05
• Last Update Submitted: 2021-05-05
• Study First Posted: 2021-05-11
• Last Update Posted: 2021-05-11
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tele-EF	Tele-Enhance Fitness	Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training

Primary Outcome Measures

Name	Time	Method
Feasibility and Acceptability of Tele-Enhance Fitness	12 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States