Optimizing Physical Activity Outcomes After Total Knee Arthroplasty

Optimizing Physical Activity Outcomes for Veterans After Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Total Knee Arthroplasty
• Intervention / Treatment: Behavioral: Physical Activity Behavior Intervention; Other: Attention Control

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Regional VA Medical Center, Aurora, CO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Free-living Daily Step Count	Accelerometer-based measurement of free-living daily step count	End of intervention (14 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-Second Chair-Stand Test W14	Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds.	End of intervention (14 weeks)
30-Second Chair-Stand Test W38	Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds.	24 weeks after intervention (week 38 of study)
Six-Minute Walk Test W14	Physical function test measuring the total distance walked in a span of six minutes.	End of intervention (14 weeks)
Six-Minute Walk Test W38	Physical function test measuring the total distance walked in a span of six minutes.	24 weeks after intervention (week 38 of study)
Timed Up-and-Go Test W14	A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting.	End of intervention (14 weeks)
Timed Up-and-Go Test W38	A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting.	24 weeks after intervention (week 38 of study)
Western Ontario and McMaster Universities Osteoarthritis Index W14	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.	End of intervention (14 weeks)
Western Ontario and McMaster Universities Osteoarthritis Index W38	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.	24 weeks after intervention (week 38 of the study)
Veterans RAND 12-Item Health Survey Physical Component W14	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.	End of intervention (14 weeks)
Veterans RAND 12-Item Health Survey Physical Component W38	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.	24 weeks after intervention (week 38 of study)
Veterans RAND 12-Item Health Survey Mental Component W14	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.	End of intervention (14 weeks)
Veterans RAND 12-Item Health Survey Mental Component W38	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.	24 weeks after intervention (week 38 of study)
Free-living Daily Step Count W38	Accelerometer-based measurement of free-living daily step count	24 weeks after intervention (week 38 of study)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Cory L. Christiansen, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Telemedicine; Physical Activity; Total Knee Arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: F2417-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will be made available at time of study completion, per VA recommendations and approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No