Study for Rural Innovations in the Delivery of Exercise

NCT04881864 | Unknown

• 1 other identifier: STUDY00011517
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Osteoarthritis

Keywords

Physical Activity; Rural; Older Adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 8-item Short Form

  Change from baseline PROMIS physical function score at 12 weeks

• Knee injury and Osteoarthritis Outcome Score (KOOS) Physical Function Subscale

  Change from Baseline KOOS Physical Function Subscale score at 12 weeks

Study Arms (1)

Tele-EF

EXPERIMENTAL

Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training

Behavioral: Tele-Enhance Fitness

Interventions

Tele-Enhance Fitness BEHAVIORAL

Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training

Tele-EF

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• cognitive impairment determined by a Mini Montreal Cognitive Assessment score of \<11
• hospitalization within the last month
• ≥3 falls within the past month

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195-6540, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 11, 2021
• Study Start: January 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)