Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure (CREMS-HF)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Device: Low electrical myostimulation

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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Abreschviller, France, 57560
    • Centre de réadaptation spécialisé Saint Luc
  • Bordeaux, France, 33077
    • Polyclinique Bordeaux Nord Aquitaine
  • Cricqueboeuf, France, 14113
    • Centre Hospitalier de la Côte Fleurie
  • Dijon, France, 21002
    • Clinique SSR "Les Rosiers"
  • Dijon, France, 21079
    • Hopital Bocage central
  • Issy-les-Moulineaux, France, 92133
    • Hôpital Corentin Celton
  • Joigny, France, 89306
    • Hôpital de Joigny
  • Lomme, France, 59160
    • Clinique de la Mitterie
  • Machecoul, France, 44270
    • Centre Hospitalier Loire Vendée Océan
  • Paris, France, 75010
    • Hôpital de jour de soins de suite et de réadaptation Léopold Bellan
  • Rennes, France, 35044
    • Clinique Saint-Yves
  • Saint Julien en Genevois, France, 74164
    • Hôpital Intercommunal Sud Léman Valserine
  • Tracy-le-Mont, France, 60170
    • Centre de réadaptation cardiaque Leopold Bellan
  • Villeneuve-Saint-Denis, France, 77174
    • Les Grands Prés

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: French Cardiology Society
• Collaborators: Gulf Estuarine Research Society (GERS); Bourgogne Association of Cardiology; Ile-de-France Association of Cardiology
• Investigators: Principal Investigator: Marie Christine Iliou, MD, Hôpital Corentin Celton

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: August 2, 2011
• First Submitted That Met QC Criteria: August 2, 2011
• First Posted (Estimate): August 3, 2011

Study Record Updates

• Last Update Posted (Estimate): March 9, 2015
• Last Update Submitted That Met QC Criteria: March 6, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Cardiac rehabilitation; Exercise training; Chronic Heart Failure; Peak VO2; Electrical myostimulation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2007-03