Optimizing Physical Activity Outcomes After Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimizing Physical Activity Outcomes for Veterans After Total Knee Arthroplasty

Conditions
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Total Knee Arthroplasty, Osteoarthritis

Intervention / Treatment
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* Behavioral: Physical Activity Behavior Intervention
* Other: Attention Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veteran Planned unilateral total knee arthroplasty Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial; Two groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Activity Behavior Intervention<br>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. | Behavioral: Physical Activity Behavior Intervention<br>* Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.<br>|
| Active Comparator: Attention Control<br>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. | Other: Attention Control<br>* Conventional rehabilitation with supplemental 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free-living daily step count | Accelerometer-based measurement of free-living daily step count | Change from pre-surgery to end of intervention (14 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-Second Chair-Stand Test | Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds. | Change from pre-surgery to end of intervention (14 weeks), persisting at 24 weeks after intervention | 
| Six-Minute Walk Test | Physical function test measuring the total distance walked in a span of six minutes. | Change from pre-surgery to end of intervention (14 weeks), persisting at 24 weeks after intervention | 
| Timed Up-and-Go Test | A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting. | Change from pre-surgery to end of intervention (14 weeks), persisting at 24 weeks after intervention | 
| Western Ontario and McMaster Universities Osteoarthritis Index | Self-report health status measure of pain, stiffness, and function for people with osteoarthritis of the hip or knee. | Change from pre-surgery to end of intervention (14 weeks), persisting at 24 weeks after intervention | 
| Veterans RAND 12-Item Health Survey | 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. | Change from pre-surgery to end of intervention (14 weeks), persisting at 24 weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Total Knee Arthroplasty, Telemedicine, Physical Activity