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Studies

Interventional Active not recruiting

NCT04107649 on ClinicalTrials.gov

Knee Arthroplasty Activity Trial

  • Sponsor: Brigham and Women's Hospital
  • Collaborators: Northwestern Memorial Hospital, University of Kansas Medical Center, University at Buffalo, University of Nebraska
  • Enrollment: 600 (Estimated)
  • Study start: 2023-04-27 (Actual)
  • Primary completion: 2028-06-15 (Estimated)
  • Study completion: 2028-06-15 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Three arm parallel randomized control trial.
  • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Knee Osteoarthritis
  • Total Knee Replacement

Intervention / Treatment

  • Behavioral: Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives
  • Behavioral: Wrist based activity tracker wear
  • Other: Basic Study Activities

Primary Outcome Measures

  • Proportion of Subjects Engaged in at least 150 min/week of moderate-to-vigorous physical activity (MVPA). (32-weeks post-TKR)
    The primary outcome of this trial is the proportion of subjects who meet or surpass the PA threshold of 150 minutes per week of at least moderate physical activity, which is defined as 3 metabolic equivalents (METs), at 32-weeks post-TKR.

Countries

United States

Locations and Investigators

  • Northwestern Memorial Hospital, Chicago, United States
  • University of Kansas Medical Center, Kansas City, United States
  • Brigham and Women's Hospital, Boston, United States
  • University of Nebraska Medical Center, Omaha, United States
  • University at Buffalo, Buffalo, United States

Study Officials