Optimizing Physical Activity Outcomes After Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Optimizing Physical Activity Outcomes for Veterans After Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226106
• Other study ID #: F2417-R
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: May 15, 2023

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Total Knee Arthroplasty

Intervention

Behavioral:
• Physical Activity Behavior Intervention
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.

Other:
• Attention Control
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.

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. 2023 Oct 11:10.1002/pmrj.13082. doi: 10.1002/pmrj.13082. Online ahead of print. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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