NCT03926312已完成不适用
Smart Device-based Cardiac Rehabilitation After Myocardial Intervention
Charles University, Czech Republic2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2019年6月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Functional capacity change
研究概览
简要总结
The aim of this study is to evaluate the influence of cardiac rehabilitation based on smart band use and telemonitoring on functional capacity change and risk factors control among patients hospitalized for acute myocardial infarction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent with the study
- •Men and women >18 years of age
- •Patients ≥1 and ≤6 months after type I myocardial infarction
- •Physical inactivity before MI defined as the absence of moderate to vigorous exercise for at least 30 minutes 5 or more days a week
排除标准
- •Heart failure NYHA IIIB-IV
- •Planned coronary revascularization
- •Planned major surgery within the next 12 months
- •Inability to walk for any reason
- •Comorbidities that would preclude adherence to the rehabilitation program (e.g. arthrosis, active malignancy, major depression or other significant psychiatric disorder, cognitive impairment) - at the discretion of the physician
- •Life expectancy less than 12 months
- •Inability to operate the smart-watch
结局指标
主要结局
Functional capacity change
时间窗: 3 months
6-minute walk test distance and maximal oxygen consumption (VO2 max) change after 3 months of the intervention
次要结局
- Body fat percentage(3 months)
- Waist circumference(3 months)
- Blood pressure(3 months)
- Smoking cessation(3 months)
- Lipid levels(3 months)
- Glycated hemoglobin(3 months)
研究者
Peter Wohlfahrt
Principal Investigator
Institute for Clinical and Experimental Medicine
研究点 (2)
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