Clinical trial NCT03226106: Optimizing Physical Activity Outcomes After Total Knee Arthroplasty
Official title: Optimizing Physical Activity Outcomes for Veterans After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Osteoarthritis
Keywords: Rehabilitation
Total Knee Arthroplasty
Telemedicine
Physical Activity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-07-21
Enrollment: 114
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial; Two groups.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Free-living Daily Step Count
timeFrame: End of intervention (14 weeks)
Secondary outcomes:
measure: 30-Second Chair-Stand Test W14
timeFrame: End of intervention (14 weeks)
measure: 30-Second Chair-Stand Test W38
timeFrame: 24 weeks after intervention (week 38 of study)
measure: Six-Minute Walk Test W14
timeFrame: End of intervention (14 weeks)
measure: Six-Minute Walk Test W38
timeFrame: 24 weeks after intervention (week 38 of study)
measure: Timed Up-and-Go Test W14
timeFrame: End of intervention (14 weeks)
measure: Timed Up-and-Go Test W38
timeFrame: 24 weeks after intervention (week 38 of study)
measure: Western Ontario and McMaster Universities Osteoarthritis Index W14
timeFrame: End of intervention (14 weeks)
measure: Western Ontario and McMaster Universities Osteoarthritis Index W38
timeFrame: 24 weeks after intervention (week 38 of the study)
measure: Veterans RAND 12-Item Health Survey Physical Component W14
timeFrame: End of intervention (14 weeks)
measure: Veterans RAND 12-Item Health Survey Physical Component W38
timeFrame: 24 weeks after intervention (week 38 of study)
measure: Veterans RAND 12-Item Health Survey Mental Component W14
timeFrame: End of intervention (14 weeks)
measure: Veterans RAND 12-Item Health Survey Mental Component W38
timeFrame: 24 weeks after intervention (week 38 of study)
measure: Free-living Daily Step Count W38
timeFrame: 24 weeks after intervention (week 38 of study)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Cory L. Christiansen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kline PW, Melanson EL, Sullivan WJ, Blatchford PJ, Miller MJ, Stevens-Lapsley JE, Christiansen CL. Improving Physical Activity Through Adjunct Telerehabilitation Following Total Knee Arthroplasty: Randomized Controlled Trial Protocol. Phys Ther. 2019 Jan 1;99(1):37-45. doi: 10.1093/ptj/pzy119.
citation: Hoffman RM, Davis-Wilson HC, Hanlon S, Swink LA, Kline PW, Juarez-Colunga E, Melanson EL, Christiansen CL. Maximal daily stepping cadence partially explains functional capacity of individuals with end-stage knee osteoarthritis. PM R. 2024 Jun;16(6):532-542. doi: 10.1002/pmrj.13082. Epub 2023 Nov 27.