Skip to main content
OpenTrials
Completed

NCT Number: NCT03226106

Optimizing Physical Activity Outcomes 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Total Knee Arthroplasty Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Physical Activity Behavior Intervention

Behavioral

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.

Attention Control

Other

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.

Primary outcomes

  1. Free-living Daily Step Count

    Time frame: End of intervention (14 weeks)

    Accelerometer-based measurement of free-living daily step count

Secondary outcomes

  1. 30-Second Chair-Stand Test W14

    Time frame: End of intervention (14 weeks)

    Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds.

  2. 30-Second Chair-Stand Test W38

    Time frame: 24 weeks after intervention (week 38 of study)

    Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds.

  3. Six-Minute Walk Test W14

    Time frame: End of intervention (14 weeks)

    Physical function test measuring the total distance walked in a span of six minutes.

  4. Six-Minute Walk Test W38

    Time frame: 24 weeks after intervention (week 38 of study)

    Physical function test measuring the total distance walked in a span of six minutes.

  5. Timed Up-and-Go Test W14

    Time frame: End of intervention (14 weeks)

    A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting.

  6. Timed Up-and-Go Test W38

    Time frame: 24 weeks after intervention (week 38 of study)

    A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting.

  7. Western Ontario and McMaster Universities Osteoarthritis Index W14

    Time frame: End of intervention (14 weeks)

    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.

  8. Western Ontario and McMaster Universities Osteoarthritis Index W38

    Time frame: 24 weeks after intervention (week 38 of the study)

    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.

  9. Veterans RAND 12-Item Health Survey Physical Component W14

    Time frame: End of intervention (14 weeks)

    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.

  10. Veterans RAND 12-Item Health Survey Physical Component W38

    Time frame: 24 weeks after intervention (week 38 of study)

    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.

  11. Veterans RAND 12-Item Health Survey Mental Component W14

    Time frame: End of intervention (14 weeks)

    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.

  12. Veterans RAND 12-Item Health Survey Mental Component W38

    Time frame: 24 weeks after intervention (week 38 of study)

    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.

  13. Free-living Daily Step Count W38

    Time frame: 24 weeks after intervention (week 38 of study)

    Accelerometer-based measurement of free-living daily step count

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Optimizing Physical Activity Outcomes for Veterans After Total Knee Arthroplasty

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2017
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.