NCT02051712招募中3 期
Cardiovascular Effects of Preferred Home-based Exercise Training and Extended Adherence Measures in Systolic Heart Failure - Pilot Study
University Medicine Greifswald2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- VO2@AT
研究概览
简要总结
The aim of the study is I. To assess whether an individualized exercise training program is superior as compared to usual care with respect to exercise tolerance, II. to assess whether intervention tools that aim to increase exercise adherence are superior to an individualized exercise training alone with respect to exercise tolerance and long-term effects, and III. to identify biomarkers that that may be implemented into novel intervention tools aiming to increase exercise adherence in patients with chronic heart failure.
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
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •women and men
- •age 30-75 years
- •chronic heart failure (NYHA II/III), left ventricular ejection fraction ≤40% be echo
- •disease duration ≥ 6 month
- •medical therapy accruing to guidelines (drug, devices, including CRT)
- •written informed consent
排除标准
- •acute myocarditis
- •instable angina
- •heart surgery (e.g. ICD implantation, bypass) with last 6 weeks; CRT implantation within the last 6 months before study start
- •severe cardiovascular events (myocardial infarction, cardiac decompensation, ICD shock, PCI due to instable angina) < 6 weeks before study start
- •preplanned hospital admission or intervention (e.g. planned revascularization, ICD implantation)
- •uncorrected valve regurgitation or stenosis (> second degree)
- •safety concerns regarding or other reasons against exercise training
- •severe depression
- •regular exercise training within the last 6 weeks
- •life expectancy < 1 year
结局指标
主要结局
VO2@AT
时间窗: Month 9
Change of cardiopulmonary exercise tolerance from baseline to 9 month follow-up measured by exercise testing: oxygen uptake at anaerobic threshold per kg body weight (METs)
次要结局
- Training adherence(9, 12, 18 and 24 month)
研究者
研究点 (2)
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