Clinical trial NCT01408875: Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure
Official title: Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Chronic Heart Failure
Cardiac rehabilitation
Exercise training
Peak VO2
Electrical myostimulation
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: Gulf Estuarine Research Society (GERS)
name: Bourgogne Association of Cardiology
name: Ile-de-France Association of Cardiology
First posted: 2011-08-03
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Peak VO2
timeFrame: at inclusion (baseline) then after 4 to 7 weeks of cardiac rehabilitation
Secondary outcomes:
measure: Changes on muscular strength
timeFrame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation
measure: Changes on sub maximal parameters
timeFrame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation
measure: Modifications of quality of life
timeFrame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation
Other outcomes:
Locations:
city: Abreschviller
country: France
facility: Centre de réadaptation spécialisé Saint Luc
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Cricqueboeuf
country: France
facility: Centre Hospitalier de la Côte Fleurie
city: Dijon
country: France
facility: Clinique SSR "Les Rosiers"
city: Dijon
country: France
facility: Hôpital Bocage Central
city: Issy-les-Moulineaux
country: France
facility: Hôpital Corentin Celton
city: Joigny
country: France
facility: Hôpital de Joigny
city: Lomme
country: France
facility: Clinique de la Mitterie
city: Machecoul
country: France
facility: Centre Hospitalier Loire Vendée Ocean
city: Paris
country: France
facility: Hôpital de jour de soins de suite et de réadaptation Léopold Bellan
city: Rennes
country: France
facility: Clinique Saint-Yves
city: Saint Julien en Genevois
country: France
facility: Hôpital Intercommunal Sud Léman Valserine
city: Tracy-le-Mont
country: France
facility: Centre de réadaptation cardiaque Leopold Bellan
city: Villeneuve-Saint-Denis
country: France
facility: Les Grands Prés
Study officials:
affiliation: Hôpital Corentin Celton
name: Marie Christine Iliou, MD
role: PRINCIPAL_INVESTIGATOR
References: