The Study of Physical Activity Rewards After Knee Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- number of steps
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Usual Care
Participants randomized to the Usual Care group will receive the current standard post-operative TKR care.
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.
干预措施: Motivational Interviewing (MI) (Behavioral)
Financial Incentives (FI)
Participants 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.
干预措施: Financial Incentives (Other)
Motivational Inverterviewing (MI) + Financial Incentives (FI)
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.
干预措施: Motivational Interviewing (MI) (Behavioral)
Motivational Inverterviewing (MI) + Financial Incentives (FI)
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.
干预措施: Financial Incentives (Other)
结局指标
主要结局
number of steps
时间窗: 6 months
The primary outcome is the average number of steps over 7 days as measured by accelerometer at 6 months post-TKR.
次要结局
- Adherence to PA guidelines(6-months)
研究者
Elena Losina
Co-Director, Orthopaedic and Arthritis Center for Outcomes Research
Brigham and Women's Hospital