Knee Arthroplasty Activity Trial
Running, not enrolling · Not applicable
Conditions studied: Knee Osteoarthritis, Total Knee Replacement
In brief
Total knee replacement (TKR) is a common and costly procedure widely used to relieve pain and improve function in patients with symptomatic advanced knee osteoarthritis (OA). As of 2013, the annual incidence of TKR was over 680,000 surgeries and annual costs exceeded $11 billion. Growing evidence suggests that while pain and functional status improve following TKR, physical activity (PA) typically does not surpass pre-TKR levels. Engagement in PA can meaningfully improve quality of life (QoL), pain, and function. Given the large investment in TKR, the effectiveness and cost-effectiveness of TKR could be substantially increased if TKR recipients became more physically active. The Knee Arthroplasty Activity Trial (KArAT) is a randomized controlled trial and participants will be randomly assigned to one of three arms. Participants across all arms will receive usual post-operative care for TKR surgery. Participants in the first arm will complete basic study activities, such as responding to surveys and attending two in-person clinic visits. Participants in the second arm will do the same and also receive a wrist-based physical activity tracker intervention. Participants in the third arm will receive a telephonic active coaching (motivational interviewing) and financial incentives (for reaching physical activity goals) (TAC(MI)+FI) based intervention, as well as a wrist-based physical activity tracker intervention. The second and third arms will be eligible to receive lottery-based financial rewards for wearing a wrist-worn activity tracker for twenty-four months during the study.
Key facts
- Study ID
- NCT04107649
- Run by
- Brigham and Women's Hospital
- People needed
- 600
- Starts
- 2023-04-27
- Expected to finish
- 2028-06-15
- Last updated by the study team
- 2025-11-24
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 40-85 years
- English-speaking
- Scheduled to undergo primary, unilateral total knee replacement (TKR) at one of the 4 recruitment centers
- OA is principal underlying indication for TKR
- During an accelerometer run-in period lasting one week at baseline (prior to surgery), subjects must show that they can comply with waist-worn physical activity tracker protocols by wearing the activity tracker for ≥4/7 days of the week for ≥10 hours/day
- Regular access to a personal computer, laptop, tablet, or smartphone for wrist-worn activity tracker syncing
- Satisfying average baseline steps/day criteria (calculated from waist-worn activity tracker data from the run-in period)
You may not qualify if…
- Non-English speaking
- Residence in nursing home
- Diagnosis of dementia, epilepsy, Parkinson's Disease, or diabetes with peripheral neuropathy
- Inflammatory arthritis (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, systemic lupus erythematosus, polymyalgia)
- Psychological issues that preclude participation
- Inpatient or other musculoskeletal surgery scheduled within six months following index primary TKR
- Uses a wheelchair to ambulate (subjects who use a cane will be eligible)
- Surgeon-documented other reason for study exclusion
- Subject does not have regular access to a device capable of receiving email or text messages
Where it is running
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- University at Buffalo — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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