Improving physical activity after knee replacement surgery
Knee Arthroplasty Activity Trial
This study is testing different ways to help people who have had knee replacement surgery be more active, including using an activity tracker and getting coaching, to see which method works best.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 5 sites (Chicago, Illinois and 4 other locations) |
| Trial ID | NCT04107649 on ClinicalTrials.gov |
What this trial studies
The Knee Arthroplasty Activity Trial (KArAT) is a randomized controlled trial aimed at enhancing physical activity levels in patients who have undergone total knee replacement (TKR) for knee osteoarthritis. Participants will be randomly assigned to one of three groups: standard post-operative care, standard care plus a wrist-based activity tracker, or standard care plus the tracker with additional telephonic coaching and financial incentives. The study seeks to evaluate the effectiveness and cost-effectiveness of these interventions in promoting sustained physical activity post-surgery. By leveraging behavioral science principles, the trial aims to improve quality of life and functional outcomes for TKR patients.
Who should consider this trial
Good fit: Ideal candidates are English-speaking individuals aged 40-85 scheduled for primary unilateral total knee replacement due to osteoarthritis.
Not a fit: Patients who are non-English speaking, reside in nursing homes, or have certain medical conditions like dementia or inflammatory arthritis may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to improved physical activity levels and overall quality of life for patients recovering from knee replacement surgery.
How similar studies have performed: Other studies have shown promise in using behavioral interventions to enhance physical activity in post-operative patients, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 this trial is running
Chicago, Illinois and 4 other locations
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- University at Buffalo — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Elena Losina, Ph.D. — Brigham and Women's Hospital
- Study coordinator: Elena Losina, Ph.D., MSC
- Email: elosina@bwh.harvard.edu
- Phone: 617-732-5338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.