Age-related Functional and Molecular Effects of Short-term Aerobic Endurance Training in Patients With Stable Chronic Heart Failure and Age-matched Healthy Controls.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Improvement in functional exercise capacity (as measured by cardiopulmonary exercise testing)
研究概览
简要总结
In both ageing and heart failure progressive exercise intolerance is observed. The Leipzig Exercise Intervention in Chronic heart failure and Aging (LEICA) study aims to investigate how aerobic short-term training interventions affect exercise capacity, left ventricular systolic and diastolic function, biomarkers of heart failure, skeletal muscle metabolism, and endothelial function in chronis heart failure patients (CHF-patients) and healthy subjects (HS) in two different age strata: Above 65 years and below 55 years.
Aim of the trial is therefore to compare the effects of aerobic exercise training in young and old healthy subjects as well as in young and old heart failure patients. To our knowledge this study is the first to prospectively investigate age differences of training responses in both CHF patients and age-matched healthy controls.
Because of the extensive clinical and molecular assessment the results of this trial will be made public in predefined substudies:
- LEICA-Echo
- LEICA-Biomarkers
- LEICA-Endothelium
- LEICA-Cardiopulmonary Exercise Function
- LEICA-Muscle
详细描述
A total of 60 healthy subjects and 60 heart failure patients (in each group 30 <55 years, 30 >65 years) are prospectively randomized to either 4 weeks of aerobic ergometer training or control group.
Before and after the intervention period maximal exercise tolerance is determined by ergospirometry, endothelial function is measured by high-resolution A-mode ultrasound, left ventricular function by echocardiography including tissue Doppler imaging, and thigh muscle mass is assessed by CT. Skeletal muscle biopsies are obtained at both time-points and are analysed for inflammatory cytokines and markers of 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1: Healthy subjects
- •normal left ventricular ejection fraction (EF) >55%
- •normal coronary artery disease (cardiac catheterization)
- •Group 2: CHF patients
- •reduced left ventricular ejection fraction (EF) <40%
- •stable clinical condition (NYHA II-III)
排除标准
- •cardiac decompensation <3 months
- •ventricular arrhythmias >Lown IVb
- •myocardial infarction < 4 weeks
- •valvular heart disease >II°
- •insulin-dependent diabetes mellitus
- •arterial hypertension
- •orthopedic conditions prohibiting training participation
结局指标
主要结局
Improvement in functional exercise capacity (as measured by cardiopulmonary exercise testing)
Echocardiography: Improvement in left ventricular diastolic function as assessed by tissue Doppler (E/E' ratio)
次要结局
- Biomarkers of heart failure (including NT-proBNP)
- Endothelial function
- Activation of the catabolic ubiquitin-proteasome pathway