Randomized Controlled Trial of Group-Based Exercise and Behavioral Health Skills Training for Older Adults with Painful Knee Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Washington
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Average Number of Steps per day
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 65 years or older
- •Community-dwelling
- •Physician diagnosis of knee OA
- •Knee pain that occurs almost daily for at least the past 3 months
- •Knee pain-related difficulty with walking or climbing stairs
- •Stiffness in the knee for <30 min/day in the morning
- •Crepitus in the knee
Exclusion Criteria
- •Non-English speaking
- •Cognitive impairment (Mini-Cog score ≤3)
- •Unable or unwilling to give informed consent or accept randomization in either study group
- •Unwilling to wear a thigh-mounted accelerometer for 1 week
- •Significant, non-corrected visual or hearing impairment
- •Plans to move out of the area in the next 12 months
- •Plans to have knee, hip, or any other major surgery (including joint replacement) in the next 12 months
- •Unable to walk a quarter of a mile independently (use of a straight cane is acceptable)
- •Prior participation in cognitive-behavioral therapy or counseling for pain
- •Exercises regularly (≥20 minutes/week of walking, hiking, dancing, or strength training, or participate in water exercise)
- •Temporary exclusion: Any of the following in the past 6 months: cancer requiring treatment (except for non-melanoma skin cancer), heart attack or failure, stroke, hip fracture, hip/knee replacement, spinal surgery, heart surgery, deep vein thrombosis, or pulmonary embolus
- •Temporary exclusion: Hospitalization in the past month
- •Temporary exclusion: Currently undergoing physical therapy or rehabilitation treatment for knee OA or impairments in mobility function
Arms & Interventions
Behavioral Health
Ten behavioral health classes.
Intervention: Behavioral Health (Behavioral)
Health Education
Ten health education classes covering healthy aging.
Intervention: Health Education (Behavioral)
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)
- Knee Pain and Function(4 months, 10 months)
- Timed Up and Go Test(4 months, 10 months)
- Patient Global Impression of Change(4 months, 10 months)
- 6 Minute Walk Test(4 months, 10 months)
- Short Physical Performance Battery(4 months, 10 months)
Investigators
Kushang Patel
Research Associate Professor: School of Medicine: Anesthesiology and Pain Medicine
University of Washington