Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure

Chronic Heart Failure Clinical Trial

— CREMS-HF  

Official title:

Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408875
• Other study ID #: 2007-03
• Status: Completed
• Phase: N/A
• First received: August 2, 2011
• Last updated: March 6, 2015
• Start date: October 2011
• Est. completion date: January 2014

Study information

• Verified date: March 2015
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
France	Centre de réadaptation spécialisé Saint Luc	Abreschviller
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	Centre Hospitalier de la Côte Fleurie	Cricqueboeuf
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

Sponsors (4)

Lead Sponsor	Collaborator
French Cardiology Society	Bourgogne Association of Cardiology, GERS, Ile-de-France Association of Cardiology

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Modifications of quality of life	Minnesota questionnaire completed by the patient	at inclusion then after 4 to 7 weeks of cardiac rehabilitation	No