Study for Rural Innovations in the Delivery of Exercise

Knee Osteoarthritis Clinical Trial

— STRIDE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04881864
• Other study ID #: STUDY00011517
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: May 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Tele-Enhance Fitness
Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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