Knee Arthroplasty Activity Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 10
- 主要终点
- Proportion of Subjects Engaged in at least 150 min/week of moderate-to-vigorous physical activity (MVPA).
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The investigators, care providers, and outcomes assessors will not be appraised of treatment arm.
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Proportion of Subjects Engaged in at least 150 min/week of moderate-to-vigorous physical activity (MVPA).
时间窗: 32-weeks post-TKR
The primary outcome of this trial is the proportion of subjects who meet or surpass the PA threshold of 150 minutes per week of at least moderate physical activity, which is defined as 3 metabolic equivalents (METs), at 32-weeks post-TKR.
次要结局
- Change in average daily sedentary time(2 weeks pre-TKR to 32-weeks post-TKR)
- Change in weekly minutes of moderate-to-vigorous activity (MVPA)(2 week pre-TKR to 32-weeks post-TKR)
- Change in average daily step count(2-week pre-TKR to 32-weeks post-TKR)
研究者
Elena Losina
Co-Director of OrACORe, Robert W. Lovett Professor of Orthopaedic Surgery at Harvard Medical School
Brigham and Women's Hospital