NCT02723422撤回不适用
Intensive Versus Usual Home-based Physical Therapy to Promote Functional Recovery After Transcatheter Aortic Valve Replacement (TAVR): A Pilot Randomized Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in level of Activity measured by activity monitor called the ActiGraph wGT3X-BT.
研究概览
简要总结
The primary purpose of this this randomized interventional study is to determine if increased level of home-based rehabilitation coupled with a pre-TAVR consultation visit in transcatheter aortic valve replacement patients will improve functional status and quality of life and will decrease hospital readmission.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of severe aortic stenosis (AS) as determined by echocardiography, who are deemed eligible for TAVR by the NYULMC Heart Valve Team
排除标准
- •Decisional impairment as assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
- •Non-English/non-Spanish speaking.
研究组 & 干预措施
Prehabilitation Visit/Increased Physical Therapy post-TAVR
Experimental
干预措施: Prehabilitation visit/increased physical therapy post-TAVR (Procedure)
Control
Active Comparator
Standard of care physical therapy post-TAVR
干预措施: Standard of Care Arm (Procedure)
结局指标
主要结局
Change in level of Activity measured by activity monitor called the ActiGraph wGT3X-BT.
时间窗: Baseline, 2 Weeks
Change in self-perceived physical health
时间窗: Baseline, 2 Weeks
Change in Independence in activities of daily living (ADLs).
时间窗: Baseline, 2 Weeks
次要结局
- Reduction in hospital readmissions following intensive home-based physical therapy reduces(Baseline, 2 Weeks)
研究者
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