Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 28
- 主要终点
- Peak VO2
研究概览
简要总结
The purpose of this study is to determine if addition of low frequency electro-myo-stimulation to cardiac rehabilitation is effective to improve exercise capacity and/or muscular strength in chronic heart failure patients.
详细描述
In chronic heart failure, low exercise capacity is due, in part, to peripheral muscles abnormalities. Exercise training performed during cardiac rehabilitation improves exercise tolerance measured by cardiopulmonary exercise test. Low frequency electromyostimulation (EMS) was proposed as an alternative to exercise training (ET) in this population.
However, the effectiveness of the combination (EMS +ET) compared with ET alone is not proved. The main objective is to compare exercise capacity judged by peak VO2 after treatment by ET alone versus EMS+ET. The secondary end points are results on sub maximal parameters, muscular resistance, quality of life and effectiveness regarding clinical sub-groups.
This study is a controlled, randomized, multicentric (14 centres) designed to include 90 patients by group in two years period. Inclusion criteria are: CHF patients , NYHA class II to IIIb, with LVEF < 40% referred to complete a cardiac rehabilitation program.
All the patients benefit from a comprehensive cardiac rehabilitation program including educational program, therapeutical optimisation and exercise training for 20 sessions, 3 to 5 days a week. The group of patients randomized for additional EMS has 20 sessions of 1 hour electrical quadricipital myostimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 18 to 75 yo
- •stable Chronic Heart Failure (CHF) under "optimal" treatment since at least 1 week
- •NYHA functional class II to IIIb
- •left ventricular ejection fraction < 40%
- •cardiopulmonary exercise test feasible
- •whatever etiology of heart failure
- •age of heart failure ≥ 3 months.
- •have signed the consent document to participate in the study
排除标准
- •previous treatment by functional electrical myo stimulation
- •recent acute heart failure or inotropic intravenous agents used (< 10 days)
- •recent coronary angioplasty (< 10 days)
- •cardiac surgery < 1 month
- •valvular disease requiring surgical treatment
- •uncontrolled hypertension (≥ systolic 180 and/or diastolic 110 mmHg)
- •severe respiratory insufficiency (VEMS < 1000 ml)
- •pregnancy
- •Automatic implantable defibrillator
- •pace-makers : cardiac stimulation dependence or not known
- •incapacity to achieve 6 min walk test and/or exercise testing
- •absolute contra-indication to exercise test and/or exercise training
- •myocarditis or pericarditis
- •uncontrolled ventricular arrhythmias
- •Obesity (BMI ≥ 35)
- •known and documented peripheral myopathy
- •participation to another study protocol
- •patient incapable of giving consent
研究组 & 干预措施
Rehabilitation Group only
Patient Heart Failure who follows physical training
Rehabilitation and EMS Group
Patient Heart Failure who follows physical training and sessions of electrical quadricipital myostimulation.
干预措施: Low electrical myostimulation (Device)
结局指标
主要结局
Peak VO2
时间窗: at inclusion (baseline) then after 4 to 7 weeks of cardiac rehabilitation
The primary outcome is the improvement of peak VO2 estimated by relative changes between before and at the end of the cardiac rehabilitation program.
次要结局
- Changes on muscular strength(at inclusion then after 4 to 7 weeks of cardiac rehabilitation)
- Modifications of quality of life(at inclusion then after 4 to 7 weeks of cardiac rehabilitation)
- Changes on sub maximal parameters(at inclusion then after 4 to 7 weeks of cardiac rehabilitation)