NCT03107897已完成不适用
Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Functional exercise capacity - Change in 6 Minute Walk Test (6MWT)
研究概览
简要总结
In this pilot study, investigators aim to identify patients undergoing TAVR who are at elevated risk for adverse clinical events due to decreased exertional capacity and physical deconditioning. Investigators aim to determine if monitored pre-procedural physical therapy is safe in these patients. Lastly, investigators aim to assess the efficacy of prehabilitation
- to improve physical functioning by the time of TAVR and to sustain benefit through 30 days post-procedure; and
- to determine its effect on post-procedural length-of-stay, clinical outcomes, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be ambulatory (with or without an assist device)
- •Subject has severe aortic stenosis and is felt an appropriate candidate for TAVR by the Heart Team.
- •Subject requires 6.0 seconds or longer to complete a 15ft walk test
- •Subject must be able to move between sitting and standing without assistance from another person.
- •Subject has adequate iliac and femoral arterial anatomy to allow for TAVR via transfemoral access
- •Subject is 18 years of age or greater
- •Subject is willing to give consent and participate in the study
排除标准
- •Subject is incapable of following instructions
- •Subject is unable to meet the minimum required physical therapy visits
- •Subject has other medical conditions rendering it unsafe, in the opinion of the Principal Investigator and physical therapy staff, to perform a 6 Minute Walk Test or physical therapy conditioning prior to TAVR
- •Subject has significant severe un-revascularized epicardial coronary disease.
结局指标
主要结局
Functional exercise capacity - Change in 6 Minute Walk Test (6MWT)
时间窗: One month post procedure
Measure: Does prehabilitation improve the subject's functional exercise capacity from first PT assessment to pre-procedure assessment and first PT assessment to one month post-procedure, as measured by the 6MWT?
次要结局
- Mobility - Timed Up and Go Test (TUG)(One month)
- Total hospital length of stay(TAVR procedure admission)
- Balance - Four Square Step Test (FSST)(One month)
- Discharge Disposition(24-48 hours post procedure)
- Length of stay in the ICU(TAVR procedure admission)
- Change in Quality of Life (KCCQ)(One month)
- 30 day readmission(30 days post procedure)
研究者
James Harvey
Principal Investigator
WellSpan Health
研究点 (2)
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