Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure

NCT ID: NCT01408875

Last Updated: 2015-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-01-31

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Rehabilitation and EMS Group

Patient Heart Failure who follows physical training and sessions of electrical quadricipital myostimulation.

Group Type: EXPERIMENTAL

Low electrical myostimulation

Intervention Type: DEVICE

The group of patients randomized for additional EMS will have 20 sessions of 1 hour electrical quadricipital myostimulation.

Rehabilitation Group only

Patient Heart Failure who follows physical training

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Low electrical myostimulation

The group of patients randomized for additional EMS will have 20 sessions of 1 hour electrical quadricipital myostimulation.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gulf Estuarine Research Society (GERS)

OTHER

Sponsor Role: collaborator

Bourgogne Association of Cardiology

UNKNOWN

Sponsor Role: collaborator

Ile-de-France Association of Cardiology

UNKNOWN

Sponsor Role: collaborator

French Cardiology Society

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie Christine Iliou, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Corentin Celton

Locations

Centre de réadaptation spécialisé Saint Luc

Abreschviller, , France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, , France

Centre Hospitalier de la Côte Fleurie

Cricquebœuf, , France

Clinique SSR "Les Rosiers"

Dijon, , France

Hôpital Bocage Central

Dijon, , France

Hôpital Corentin Celton

Issy-les-Moulineaux, , France

Hôpital de Joigny

Joigny, , France

Clinique de la Mitterie

Lomme, , France

Centre Hospitalier Loire Vendée Ocean

Machecoul, , France

Hôpital de jour de soins de suite et de réadaptation Léopold Bellan

Paris, , France

Clinique Saint-Yves

Rennes, , 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

Countries

France

Other Identifiers

2007-03

Identifier Type: -

Identifier Source: org_study_id