Impact of Three Months of Aerobic Exercise Training on Exercise Capacity and Peripheral Maladaptations in Patients With Severe Chronic Heart Failure (NYHA III b)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Peak oxygen uptake
研究概览
简要总结
Patients with heart failure are limited in their exercise capacity due to skeletal muscle alteration and an impairment of peripheral perfusion. Regular physical exercise training has been shown to partially correct these peripheral maladaptations in patients with stable heart failure, which was associated with an improvement in exercise capacity. However, it is unknown so far, whether regular physical activity also exerts beneficial effects in patients with severe chronic heart failure.
Aim of the trial is therefore to assess the effects of aerobic exercise training on exercise capacity, muscle maladaptations and peripheral perfusion in patients with severe chronic heart failure according to NYHA class III b.
详细描述
A total of 36 patients with severe chronic heart failure are prospectively randomized to either 3 months of aerobic ergometer training or a sedentary control group.
Before and after the intervention period maximal exercise capacity is assessed by ergospirometry, endothelial function is determined by high-resolution A-mode ultrasound, and muscle mass is determined by CT. Skeletal muscle biopsies are obtained at begin and after 3 months and are analyzed for markers of muscle catabolism/anabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •chronic heart failure (NYHA class III b)
- •peak oxygen uptake <20 mL/min/kg body weight
- •left ventricular ejection fraction <25 %
- •left ventricular end-diastolic diameter >60 mm
排除标准
- •exercise-induced myocardial ischemia
- •cardiac decompensation within the last 8 weeks
- •ventricular arrhythmias (>Lown 4b) in patients not protected by an ICD
- •insulin-dependent diabetes mellitus
- •uncontrolled arterial hypertension
- •orthopedic conditions excluding training participation
- •body mass index >30 kg/m2
结局指标
主要结局
Peak oxygen uptake
次要结局
- Skeletal muscle mass
- Endothelial function
- Markers of muscle anabolism / catabolism