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Total Knee ArthroplastyNCT03226106

Optimizing Physical Activity Outcomes After Total Knee Arthroplasty

A study testing Physical Activity Behavior Intervention in people with Total Knee Arthroplasty and Osteoarthritis, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Total Knee Arthroplasty, Osteoarthritis
What is being tested?
Physical Activity Behavior Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteUnited States
Study dates
15 Nov 2017to 15 May 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Veteran
  • Planned unilateral total knee arthroplasty

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Physical Activity Behavior Intervention, Attention Control
Keywords
Rehabilitation, Total Knee Arthroplasty, Telemedicine, Physical Activity
Medical subject headings
Osteoarthritis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity Behavior InterventionBehavioural

    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 ControlOther

    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.

Study groups in NCT03226106
Study groupRoleWhat they receive
Physical Activity Behavior InterventionExperimentalA 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.
Receives: Behavioral: Physical Activity Behavior Intervention
Attention ControlActive comparatorConventional 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.
Receives: Other: Attention Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Free-living Daily Step Count

    Accelerometer-based measurement of free-living daily step count

    Measured: End of intervention (14 weeks)

Secondary outcomes (13)

  1. 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.

    Measured: End of intervention (14 weeks)

  2. 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.

    Measured: 24 weeks after intervention (week 38 of study)

  3. Six-Minute Walk Test W14

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

    Measured: End of intervention (14 weeks)

  4. Six-Minute Walk Test W38

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

    Measured: 24 weeks after intervention (week 38 of study)

  5. 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.

    Measured: End of intervention (14 weeks)

  6. 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.

    Measured: 24 weeks after intervention (week 38 of study)

  7. 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.

    Measured: End of intervention (14 weeks)

  8. 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.

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

  9. 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.

    Measured: End of intervention (14 weeks)

  10. 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.

    Measured: 24 weeks after intervention (week 38 of study)

  11. 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.

    Measured: End of intervention (14 weeks)

  12. 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.

    Measured: 24 weeks after intervention (week 38 of study)

  13. Free-living Daily Step Count W38

    Accelerometer-based measurement of free-living daily step count

    Measured: 24 weeks after intervention (week 38 of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2017
  2. Study start15 Nov 2017
  3. Primary completion15 May 2023
  4. Study completion15 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial; Two groups.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03226106
Sponsor's protocol ID
F2417-R
Status last verified
Oct 2024
First submitted
14 Jul 2017
Last updated
16 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Participant data will be made available at time of study completion, per VA recommendations and approval.

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.

    PubMed 30329126

  • 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.

    PubMed 37819260

  • Hanlon SL, Miller MJ, Swink LA, Hoffman RM, Kline PW, Christiansen CL. Preoperative physical health and psychosocial characteristics influence postoperative mobility in veterans following total knee arthroplasty: A structural equation modeling approach. PM R. 2026 Mar;18(3):305-314. doi: 10.1002/pmrj.13439. Epub 2025 Aug 8.

    PubMed 40776781

  • Christiansen CL, Kline PW, Anderson CB, Melanson EL, Sullivan WJ, Richardson VL, Juarez-Colunga E, Stevens-Lapsley JE. Optimizing Total Knee Arthroplasty Rehabilitation With Telehealth Physical Activity Behavior Change Intervention: A Randomized Clinical Trial. Phys Ther. 2024 Oct 2;104(10):pzae088. doi: 10.1093/ptj/pzae088.

    PubMed 39001713

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity Behavior Intervention in people with Total Knee Arthroplasty and Osteoarthritis, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Free-living Daily Step Count (time frame: End of intervention (14 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03226106, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.

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