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The Study of Physical Activity Rewards After Knee Surgery

Not Applicable
Completed
Conditions
Osteoarthritis
Degenerative Joint Disease
Interventions
Behavioral: Motivational Interviewing (MI)
Other: Financial Incentives
Registration Number
NCT01970631
Lead Sponsor
Brigham and Women's Hospital
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
202
Inclusion Criteria
  • Scheduled to undergo primary TKA at BWH
  • Osteoarthritis is the principal underlying diagnosis
  • Age >=40 at the projected date of TKA
  • English-speaking
  • Willing and able to access the internet to complete study related questionnaires
Exclusion Criteria
  • Osteoarthritis is not the principal underlying diagnosis (e.g. inflammatory arthritis)
  • Dementia (can not fill out forms)
  • Psychological issues that preclude participation, as identified by participating surgeons
  • Does not have access to a computer and/or the internet.
  • Non-English speaker (instruments are not validated in Spanish); very few non-English speakers (<5%) are otherwise eligible
  • Age <40 at the projected date of TKA (TKA is usually due to major trauma, juvenile onset or congenital disease)
  • Lives in a nursing home (difficult to track costs)
  • Implantation of Unicompartamental Knee Arthroscopy (different clinical features and different costs)
  • Bilateral TKA in same admission (simultaneous), staged or within 6 months
  • Uses a wheelchair or walker to ambulate
  • Has been told by a physician that he/she has a heart condition and should only do physical activity recommended by a doctor
  • Has pain in his/her chest when doing physical activity
  • Loses balance because of dizziness
  • Loses consciousness
  • Unable/unwilling to wear Fitbit® accelerometer for 5 or more days during baseline visit

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Motivational Inverterviewing (MI) + Financial Incentives (FI)Motivational Interviewing (MI)Participants randomized to the FI + MI Intervention group will receive financial incentives for completing physical activity logs weekly/bi-weekly and achieving pre-specified physical activity goals as well as receive up to 14 telephone calls from a Health Educator for 9 months post-TKR.
Motivational Inverterviewing (MI) + Financial Incentives (FI)Financial IncentivesParticipants randomized to the FI + MI Intervention group will receive financial incentives for completing physical activity logs weekly/bi-weekly and achieving pre-specified physical activity goals as well as receive up to 14 telephone calls from a Health Educator for 9 months post-TKR.
Motivational Interviewing (MI)Motivational Interviewing (MI)Participants randomized to the MI Intervention group will receive up to 14 telephone calls from a Health Educator for 9 months post-TKR.
Financial Incentives (FI)Financial IncentivesParticipants randomized to the FI Intervention group will receive financial incentives for completing physical activity logs weekly/bi-weekly and achieving pre-specified physical activity goals over the course of the study.
Primary Outcome Measures
NameTimeMethod
number of steps6 months

The primary outcome is the average number of steps over 7 days as measured by accelerometer at 6 months post-TKR.

Secondary Outcome Measures
NameTimeMethod
Adherence to PA guidelines6-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.

Trial Locations

Locations (1)

Brigham and Women's Hospital

🇺🇸

Boston, Massachusetts, United States

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