Randomized Controlled Trial of Group-Based Exercise and Behavioral Health Skills Training for Older Adults with Painful Knee Osteoarthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteo Arthritis Knee
- Sponsor
- University of Washington
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Average Number of Steps per day
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
This clinical trial will determine the added benefit of combining exercise and behavioral health education (versus exercise and aging and health education) to improve physical activity in community-dwelling older adults who have painful knee osteoarthritis (OA).
Detailed Description
Knee osteoarthritis (OA) is a highly prevalent, leading cause of pain that limits physical functioning in older adults. Although clinical practice guidelines recommend physical exercise for managing symptoms of knee OA, several systematic reviews indicate that exercise intervention studies provide only short-term benefits (lasting 6 months) for knee OA. Many older adults with painful knee OA return to sedentary lifestyles when structured exercise programs end6. Efforts to increase and sustain physical activity in this population will require promoting self-regulatory skills to develop confidence to maintain an active lifestyle and manage symptoms that often limit activity. Therefore, we developed a group-based behavioral health (BH) program for older adults with painful knee OA that complements Enhance Fitness (EF) - a multicomponent, community-based exercise program for older adults, involving balance, strength, and endurance training. The Behavioral Health (BH) program will have 10, 1-hour weekly classes spread over 4 months, while the Health Education (HE) program will be equally matched for attention with classes on aging and health. In parallel with BH/HE programs, all study subjects will participate in Enhance Fitness (EF) exercise classes that will be held for 1-hour, 3 times a week for 4 months. EF+BH intervention (versus EF+HE) improves physical activity, pain, physical function, and other outcomes in older adults with knee OA. Due to the COVID-19 pandemic, all interventions transitioned to remote delivery in 2020.
Investigators
Kushang Patel
Research Associate Professor: School of Medicine: Anesthesiology and Pain Medicine
University of Washington
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Average Number of Steps per day
Time Frame: 4 months,10 months
Participant's average number of steps per day will be measured by a thigh mounted accelerometer (acitvPAL) worn for 1 week.
Secondary Outcomes
- Fatigue(4 months, 10 months)
- Study Specific Treatment Satisfaction Questionnaire(4 months, 10 months)
- Patient Global Impression of Change(4 months, 10 months)
- Knee Pain and Function(4 months, 10 months)
- Timed Up and Go Test(4 months, 10 months)
- 6 Minute Walk Test(4 months, 10 months)
- Short Physical Performance Battery(4 months, 10 months)