Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure

Not Applicable

Completed

• Conditions: Chronic Heart Failure
• Interventions: Device: Low electrical myostimulation

• Registration Number: NCT01408875
• Lead Sponsor: French Cardiology Society

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Study Start: 2011-10
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-06
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitation and EMS Group	Low electrical myostimulation	Patient Heart Failure who follows physical training and sessions of electrical quadricipital myostimulation.

Primary Outcome Measures

Name	Time	Method
Peak VO2	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.

Secondary Outcome Measures

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

Trial Locations

Locations (14)

Centre Hospitalier de la Côte Fleurie; 🇫🇷 Cricqueboeuf, France

Clinique Saint-Yves; 🇫🇷 Rennes, France

Centre de réadaptation spécialisé Saint Luc; 🇫🇷 Abreschviller, France

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

Hôpital Bocage Central; 🇫🇷 Dijon, France

Clinique SSR "Les Rosiers"; 🇫🇷 Dijon, France

Hôpital de Joigny; 🇫🇷 Joigny, France

Hôpital Corentin Celton; 🇫🇷 Issy-les-Moulineaux, France

Centre Hospitalier Loire Vendée Ocean; 🇫🇷 Machecoul, France

Clinique de la Mitterie; 🇫🇷 Lomme, France

Hôpital de jour de soins de suite et de réadaptation Léopold Bellan; 🇫🇷 Paris, France

Hôpital Intercommunal Sud Léman Valserine; 🇫🇷 Saint Julien en Genevois, France

Centre de réadaptation cardiaque Leopold Bellan; 🇫🇷 Tracy-le-Mont, France

Les Grands Prés; 🇫🇷 Villeneuve-Saint-Denis, France