NCT02046707已完成不适用
Evaluation of the Effects of Eccentric Muscle Training Versus Conventional Concentric Training in Chronic Heart Failure
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Evolution of performance in the 6-minute walk test between the initial assessment and the final assessment of a reconditioning programme
研究概览
简要总结
This is a single-centre open randomized parallel-group study. Patients will be selected at random to be included in group 1: eccentric rehabilitation or group 2: conventional rehabilitation.
In addition, a group of healthy volunteers aged between 20 and 85 years will also be recruited. This group will make it possible to evaluate, during the two exercise sessions, mechanisms of adaptation linked to eccentric exercise vs concentric exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have provided written informed consent
- •Patients with national health insurance cover
- •Men or women aged between 45 and 85 years with stabilized chronic heart failure (ischemic or dilated cardiopathy) for at least one month, New York Heart Association stage>
- •Echocardiographic left ventricular ejection fraction (Simpson method) < 45% OR N-terminal-ProBNP > 3 x upper limit of normal* (*= 125pg/ml for the CHU laboratory).
- •First period of rehabilitation for chronic heart failure.
- •Healthy volunteers:
- •Subjects who have provided written informed consent
- •Subjects with national health insurance cover
- •Men or women aged between 18 and 85 years.
排除标准
- •persons without national health insurance cover
- •Severe obstructive cardiopathy,
- •severe aortic valve stenosis,
- •severe progressive heart rhythm or conduction disorders not corrected with a pacemaker, discovered at the initial effort test
- •intra-cavitary thrombus,
- •severe pulmonary artery hypertension (systolic pulmonary arterial hypertension >70mmHg),
- •recent history of venous trombo-embolism (last 3 months),
- •impaired executive function making it impossible to understand and follow reconditioning programme (Mini Mental Test < 24),
- •heart transplant,
- •associated medical disorders that could predominately impair functional capacity compared with the chronic heart failure (examples: respiratory insufficiency, non-stabilized metabolic disorders such as progressive kidney failure, severe asthenia related to a severe non-stabilized disorder such as neoplasia, systemic disease...).
- •associated chronic motor deficit of a neurological origin (example: sequelae of a cerebrovascular accident), an osteo-articular origin (example: impairment due to Rheumatoid arthritis), of a peripheral vascular disease (example: peripheral artery disease, venous disease, lymphedema) will not be included in the exclusion criteria provided thay are compatible with the level of physical ability defined in the inclusion criteria. The presence of an implantable pacemaker and/or defibrillator will not be an exclusion criterion
- •Healthy volunteers:
- •persons without national health insurance cover
- •Any organic disorder whatever its nature (cardiac, respiratory, neurological, orthopedic, ...) that could affect adaptation to effort or is a contra-indication for physical activity.
研究组 & 干预措施
Patients with chronic heart failure
Experimental
干预措施: final evaluation (Other)
Patients with chronic heart failure
Experimental
干预措施: initial evaluation (Other)
Patients with chronic heart failure
Experimental
干预措施: Period of cardiac rehabilitation (Other)
Controls
Other
干预措施: Concentric and eccentric exercise sessions (Other)
结局指标
主要结局
Evolution of performance in the 6-minute walk test between the initial assessment and the final assessment of a reconditioning programme
时间窗: 12 weeks
次要结局
- Evolution of functional and physiological capacities and tolerance criteria(12 weeks)
研究者
研究点 (2)
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