Knee Arthroplasty Activity Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:

• 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)

Locations
United States
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New York
University at Buffalo
RECRUITING
Buffalo
Contact Information
Primary
Elena Losina, Ph.D., MSC
elosina@bwh.harvard.edu
617-732-5338
Backup
Faith Selzer, Ph.D.
fselzer@bwh.harvard.edu
617-525-8617
Time Frame
Start Date: 2023-04-27
Estimated Completion Date: 2028-06-15
Participants
Target number of participants: 600
Treatments
Other: Arm1
Participants in this arm receive usual post-operative care and complete all basic study activities, which include: attending 2 in-clinic visits at designated time-points, having regular check-in calls with study staff over the intervention period, wearing and returning waist-worn activity trackers at 5 time points over two years, and completing 6 study surveys.
Experimental: Arm2
Participants in this arm receive usual post-operative care, complete all basic study activities (as described in arm 1) and receive the wrist-based activity tracker intervention.
Experimental: Arm3
Participants in this arm receive usual post-operative care, complete all basic study activities (as described in arm 1), receive wrist-based activity tracker intervention, and receive the TAC(MI)+FI.
Authors
Christine Pellegrini, M. Elaine Husni
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: University of Nebraska, University of Kansas Medical Center, Northwestern Memorial Hospital, University at Buffalo

This content was sourced from clinicaltrials.gov