Clinical trial NCT04107649: Knee Arthroplasty Activity Trial
Official title: Knee Arthroplasty Activity Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Total Knee Replacement
Keywords: Physical Activity
Total Knee Replacement
Knee Osteoarthritis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Northwestern Memorial Hospital
name: University of Kansas Medical Center
name: University at Buffalo
name: University of Nebraska
First posted: 2019-09-27
Enrollment: 600
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three arm parallel randomized control trial.
Primary purpose: 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.

Detailed description: The investigators have designed the KArAT trial with two specific aims. First, to conduct a parallel three-arm RCT to establish the efficacy and sustainability of the effect of personalized intervention built on the principles of behavioral science and behavioral economics in improving PA among sedentary people who have undergone TKR. Our second aim is to establish the cost-effectiveness and budget impact of TAC(MI)+FI to improve PA in persons who have undergone TKR.

The three arms will include:

Arm 1: Usual post-TKR care

Arm 2: Usual post-TKR care + Wrist-based physical activity tracker wear

Arm 3: Usual post-TKR care + Wrist-based physical activity tracker wear + Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives (TAC(MI)+FI).

Eligibility 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

Primary outcomes:
measure: Proportion of Subjects Engaged in at least 150 min/week of moderate-to-vigorous physical activity (MVPA).
timeFrame: 32-weeks post-TKR
Secondary outcomes:
measure: Change in average daily step count
timeFrame: 2-week pre-TKR to 32-weeks post-TKR
measure: Change in weekly minutes of moderate-to-vigorous activity (MVPA)
timeFrame: 2 week pre-TKR to 32-weeks post-TKR
measure: Change in average daily sedentary time
timeFrame: 2 weeks pre-TKR to 32-weeks post-TKR
Other outcomes:
measure: Durability of changes in activity levels
timeFrame: 2 weeks pre-TKR to 24 months post-TKR
measure: Change in pain and functional status
timeFrame: 2 weeks pre-TKR to 24 months post-TKR
measure: Change in quality of life
timeFrame: 2 weeks pre-TKR to 24 months post-TKR
measure: Change in performance measures
timeFrame: 2 weeks pre-TKR to 6 months post-TKR
measure: Change in cost
timeFrame: 2 weeks pre-TKR to 24 months post-TKR
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: Brigham and Women's Hospital
name: Elena Losina, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: