Optimizing Physical Activity Outcomes After Total Knee Arthroplasty

April 12, 2024 updated by: VA Office of Research and Development

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Change from pre-surgery to end of intervention (14 weeks)
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
Time Frame: Change from pre-surgery to end of intervention (14 weeks), persisting at 24 weeks after intervention
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
Time Frame: Change from pre-surgery to end of intervention (14 weeks), persisting at 24 weeks after intervention
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
Time Frame: Change from pre-surgery to end of intervention (14 weeks), persisting at 24 weeks after intervention
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
Time Frame: Change from pre-surgery to end of intervention (14 weeks), persisting at 24 weeks after intervention
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
Time Frame: Change from pre-surgery to end of intervention (14 weeks), persisting at 24 weeks after intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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