Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Device: Low electrical myostimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation and EMS Group<br>Patient Heart Failure who follows physical training and sessions of electrical quadricipital myostimulation. | Device: Low electrical myostimulation<br>* The group of patients randomized for additional EMS will have 20 sessions of 1 hour electrical quadricipital myostimulation.<br>|
| No Intervention: Rehabilitation Group only<br>Patient Heart Failure who follows physical training | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak VO2 | The primary outcome is the improvement of peak VO2 estimated by relative changes between before and at the end of the cardiac rehabilitation program. | at inclusion (baseline) then after 4 to 7 weeks of cardiac rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on muscular strength | Measure of weight that the patient can lift 3 times but not four with quadriceps. | at inclusion then after 4 to 7 weeks of cardiac rehabilitation | 
| Changes on sub maximal parameters | Measure of ventilatory threshold and walk test of 6 min. | at inclusion then after 4 to 7 weeks of cardiac rehabilitation | 
| Modifications of quality of life | Minnesota questionnaire completed by the patient | at inclusion then after 4 to 7 weeks of cardiac rehabilitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Heart Failure, Cardiac rehabilitation, Exercise training, Peak VO2, Electrical myostimulation