Optimizing Physical Activity Outcomes After Total Knee Arthroplasty
- Conditions
- OsteoarthritisTotal Knee Arthroplasty
- Interventions
- Other: Attention ControlBehavioral: Physical Activity Behavior Intervention
- Registration Number
- NCT03226106
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
Although total knee arthroplasty is an effective intervention for decreasing knee pain and improving physical function, physical activity levels remain low up to a year after surgery. This study will use mobile-health technology to deliver an intervention designed to improve physical activity behavior for Veterans recovering from total knee arthroplasty. The study will assess the effectiveness of using behavior-change intervention as a supplement to conventional rehabilitation to improve physical activity. The intervention will be delivered using home-based tablet computers for Veterans to have remote interaction with the researcher and real-time physical activity feedback from a wrist-worn activity sensor.
- Detailed Description
This randomized clinical trial will assess the efficacy of using physical activity behavior change intervention for Veterans recovering from total knee arthroplasty. Testing will occur at baseline (before surgery), at intervention midpoint (8 weeks after surgery), end of intervention (14 weeks after surgery), and 24 weeks after intervention. The primary outcome is accelerometer-assessed daily step count. Secondary outcomes include the percent time engaged in standing and walking activity and physical function (Six-Minute Walk, 30-Second Chair-Stand Test, Timed Up-and-Go, Western Ontario and McMaster Universities Osteoarthritis Index, and the Veterans RAND 12-Item Health Survey.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- Veteran
- Planned unilateral total knee arthroplasty
- Severe non-surgical limb pain (pain >5/10 on non-surgical limb with walking)
- Unstable orthopedic, neurologic, or pulmonary condition that limits function
- Unstable cardiac condition
- Uncontrolled hypertension
- Uncontrolled diabetes
- Acute systemic infection
- Active cancer treatment
- Recent stroke (within 2 years)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Attention Control Attention Control Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions. Physical Activity Behavior Intervention Physical Activity Behavior Intervention A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.
- Primary Outcome Measures
Name Time Method Free-living Daily Step Count End of intervention (14 weeks) Accelerometer-based measurement of free-living daily step count
- Secondary Outcome Measures
Name Time Method 30-Second Chair-Stand Test W14 End of intervention (14 weeks) Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds.
30-Second Chair-Stand Test W38 24 weeks after intervention (week 38 of study) Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds.
Six-Minute Walk Test W14 End of intervention (14 weeks) Physical function test measuring the total distance walked in a span of six minutes.
Six-Minute Walk Test W38 24 weeks after intervention (week 38 of study) Physical function test measuring the total distance walked in a span of six minutes.
Timed Up-and-Go Test W14 End of intervention (14 weeks) A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting.
Timed Up-and-Go Test W38 24 weeks after intervention (week 38 of study) A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting.
Western Ontario and McMaster Universities Osteoarthritis Index W14 End of intervention (14 weeks) Self-report health status measure of pain, stiffness, and function for people with osteoarthritis of the hip or knee. A higher score indicates worse outcome with the Total Score range from 0-96. A positive change indicates worse outcome and a negative change indicates a better outcome across time points.
Western Ontario and McMaster Universities Osteoarthritis Index W38 24 weeks after intervention (week 38 of the study) Self-report health status measure of pain, stiffness, and function for people with osteoarthritis of the hip or knee. A higher score indicates worse outcome with the Total Score range from 0-96. A positive change indicates worse outcome and a negative change indicates a better outcome across time points.
Veterans RAND 12-Item Health Survey Physical Component W14 End of intervention (14 weeks) A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Veterans RAND 12-Item Health Survey Physical Component W38 24 weeks after intervention (week 38 of study) A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Veterans RAND 12-Item Health Survey Mental Component W14 End of intervention (14 weeks) A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Veterans RAND 12-Item Health Survey Mental Component W38 24 weeks after intervention (week 38 of study) A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Free-living Daily Step Count W38 24 weeks after intervention (week 38 of study) Accelerometer-based measurement of free-living daily step count
Trial Locations
- Locations (1)
Rocky Mountain Regional VA Medical Center, Aurora, CO
🇺🇸Aurora, Colorado, United States