Optimizing Physical Activity Outcomes for Veterans After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Free-living Daily Step Count
研究概览
简要总结
Although total knee arthroplasty is an effective intervention for decreasing knee pain and improving physical function, physical activity levels remain low up to a year after surgery. This study will use mobile-health technology to deliver an intervention designed to improve physical activity behavior for Veterans recovering from total knee arthroplasty. The study will assess the effectiveness of using behavior-change intervention as a supplement to conventional rehabilitation to improve physical activity. The intervention will be delivered using home-based tablet computers for Veterans to have remote interaction with the researcher and real-time physical activity feedback from a wrist-worn activity sensor.
详细描述
This randomized clinical trial will assess the efficacy of using physical activity behavior change intervention for Veterans recovering from total knee arthroplasty. Testing will occur at baseline (before surgery), at intervention midpoint (8 weeks after surgery), end of intervention (14 weeks after surgery), and 24 weeks after intervention. The primary outcome is accelerometer-assessed daily step count. Secondary outcomes include the percent time engaged in standing and walking activity and physical function (Six-Minute Walk, 30-Second Chair-Stand Test, Timed Up-and-Go, Western Ontario and McMaster Universities Osteoarthritis Index, and the Veterans RAND 12-Item Health Survey.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned unilateral total knee arthroplasty
排除标准
- •Severe non-surgical limb pain (pain >5/10 on non-surgical limb with walking)
- •Unstable orthopedic, neurologic, or pulmonary condition that limits function
- •Unstable cardiac condition
- •Uncontrolled hypertension
- •Uncontrolled diabetes
- •Acute systemic infection
- •Active cancer treatment
- •Recent stroke (within 2 years)
结局指标
主要结局
Free-living Daily Step Count
时间窗: End of intervention (14 weeks)
Accelerometer-based measurement of free-living daily step count
次要结局
- 30-Second Chair-Stand Test W14(End of intervention (14 weeks))
- 30-Second Chair-Stand Test W38(24 weeks after intervention (week 38 of study))
- Six-Minute Walk Test W14(End of intervention (14 weeks))
- Six-Minute Walk Test W38(24 weeks after intervention (week 38 of study))
- Timed Up-and-Go Test W14(End of intervention (14 weeks))
- Timed Up-and-Go Test W38(24 weeks after intervention (week 38 of study))
- Western Ontario and McMaster Universities Osteoarthritis Index W14(End of intervention (14 weeks))
- Western Ontario and McMaster Universities Osteoarthritis Index W38(24 weeks after intervention (week 38 of the study))
- Veterans RAND 12-Item Health Survey Physical Component W14(End of intervention (14 weeks))
- Veterans RAND 12-Item Health Survey Physical Component W38(24 weeks after intervention (week 38 of study))
- Veterans RAND 12-Item Health Survey Mental Component W14(End of intervention (14 weeks))
- Veterans RAND 12-Item Health Survey Mental Component W38(24 weeks after intervention (week 38 of study))
- Free-living Daily Step Count W38(24 weeks after intervention (week 38 of study))