NCT04166682Unknown不适用
A Study of the Impact of Home-based Cardiac Rehabilitation on Outcomes After Transcatheter Aortic Valve Replacement (TAVR)
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年5月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 6-minute walk test
研究概览
简要总结
To evaluate the effects of a home-based cardiac rehabilitation program for Chinese patients after Transcatheter Aortic Valve Replacement (TAVR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aortic stenosis accepted for TAVR
- •Participant able and willing to give written informed consent
- •Participant able (in the investigator's opinion) and willing to comply with all study requirements
排除标准
- •subjects may not enter the study if any of the following apply
- •Intervention deemed inappropriate due to co-morbidity or frailty
- •Life expectancy less than one year due to co-morbidity
- •Previous surgical aortic valve replacement (sAVR) or TAVR
- •Predominant aortic regurgitation
研究组 & 干预措施
Control Group
Placebo Comparator
Routine care
干预措施: Routine care (Behavioral)
Interventional Group
Experimental
Home-based cardiac rehabilitation
干预措施: Home-based cardiac rehabilitation (Behavioral)
结局指标
主要结局
6-minute walk test
时间窗: 6 weeks
The total distance walked in meters during 6 minutes.
次要结局
- Number of participants rehospitalized(6 weeks, 12 months)
- Aortic valve function(12 months)
- Number of participants die(6 weeks, 12 months)
- Number of participants completing home-based cardiac rehabilitation(6 weeks)
- Cardiac function(12 months)
- Number of participants injured(6 weeks)
- 6-minute walk test(12 months)
- Time spent performing activities(6 weeks, 12 months)
研究者
研究点 (1)
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