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Trial record 1 of 3 for:    christiansen | arthroplasty
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Optimizing Physical Activity Outcomes After Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03226106
Recruitment Status : Active, not recruiting
First Posted : July 21, 2017
Last Update Posted : August 4, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Osteoarthritis Behavioral: Physical Activity Behavior Intervention Other: Attention Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial; Two groups.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Physical Activity Outcomes for Veterans After Total Knee Arthroplasty
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226106


Locations
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United States, Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Cory L. Christiansen, PhD Rocky Mountain Regional VA Medical Center, Aurora, CO
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03226106    
Other Study ID Numbers: F2417-R
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participant data will be made available at time of study completion, per VA recommendations and approval.

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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
Keywords provided by VA Office of Research and Development:
Rehabilitation
Total Knee Arthroplasty
Telemedicine
Physical Activity
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases