Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT01970631
The objectives of this research are to conduct a proof of concept randomized controlled trial with 200 patients undergoing primary total knee replacement (TKR) at Brigham and Women's Hospital (BWH). The trial will compare levels of physical activity in subjects in the behavioral and economic interventions versus "Usual Care" post TKR.
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Notify Me40 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
Physical activity (PA) has been shown to improve pain and function in persons with knee osteoarthritis (OA), reduce obesity, and prevent the onset and progression of heart disease, diabetes, and chronic pulmonary disease. The US Department of Human and Health Services (DHHS) guidelines recommend that adults engage in >150 minutes of moderate physical activity per week. However, adherence to PA guidelines is poor in the general population, particularly in persons with knee OA.
Total knee replacement (TKR) is widely used in patients with symptomatic, advanced knee OA. While the vast majority of persons undergoing TKR experience considerable reduction in pain and improvement in functional capacity, far fewer take this opportunity to become more physically active. Since physical activity has a direct relationship with quality of life and with prevention and amelioration of many chronic conditions, many TKR recipients do not derive maximum benefits from the procedure.
The focus of this proposal is to conduct a proof of concept RCT to establish the efficacy of a behavioral economics-based intervention that would facilitate engagement in physical activity and improve adherence to PA guidelines in the growing population of TKR recipients. We address the innovative hypothesis that the period following TKR presents a window of opportunity to fundamentally change attitudes and beliefs regarding PA, and that tangible economic incentives will effectively induce behavior change and facilitate adherence to PA guidelines.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The motivational interviewing arms of SPARKS will consist of Health Educators trained in Motivational Interviewing (MI) techniques contacting participants at regular intervals over the course of the nine months following participants' total knee replacement (TKR).
The financial intervention arms of SPARKS will provide compensation to participants for completing physical activity logs weekly/bi-weekly and reaching pre-specified physical activity goals.
Time frame: 6 months
The primary outcome is the average number of steps over 7 days as measured by accelerometer at 6 months post-TKR.
Time frame: 6-months
The secondary outcome will be adherence to PA guidelines, defined by the DHHS as >150 minutes of moderate or greater intensity PA occurring in bouts of 10 minutes or more per week.
Brigham and Women's Hospital
Other
Acronym: SPARKS
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