Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure (CREMS-HF)
This study is currently recruiting participants.
Verified April 2013 by French Cardiology Society
Sponsor:
French Cardiology Society
Collaborators:
GERS
Bourgogne Association of Cardiology
Ile-de-France Association of Cardiology
Information provided by:
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01408875
First received: August 2, 2011
Last updated: April 8, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Heart Failure |
Device: Low electrical myostimulation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure |
Resource links provided by NLM:
Further study details as provided by French Cardiology Society:
Primary Outcome Measures:
- Peak VO2 [ Time Frame: at inclusion (baseline) then after 4 to 7 weeks of cardiac rehabilitation ] [ Designated as safety issue: No ]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:
- Changes on muscular strength [ Time Frame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation ] [ Designated as safety issue: No ]Measure of weight that the patient can lift 3 times but not four with quadriceps.
- Changes on sub maximal parameters [ Time Frame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation ] [ Designated as safety issue: No ]Measure of ventilatory threshold and walk test of 6 min.
- Modifications of quality of life [ Time Frame: at inclusion then after 4 to 7 weeks of cardiac rehabilitation ] [ Designated as safety issue: No ]Minnesota questionnaire completed by the patient
| Estimated Enrollment: | 180 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408875
Contacts
| Contact: Marie-Christine Iliou, MD | +33 (0)1 58 00 42 12 | marie-christine.iliou@ccl.aphp.fr |
| Contact: Bénédicte Vergès, MD | +33 (0)3 80 44 50 34 | b.verges@gsante.fr |
Locations
| France | |
| Centre de réadaptation spécialisé Saint Luc | Recruiting |
| Abreschviller, France, 57560 | |
| Contact: Eric Kessler, MD | |
| Principal Investigator: Eric Kessler, MD | |
| Sub-Investigator: Pascale Mansuy, MD | |
| Sub-Investigator: Michel Ross, MD | |
| Polyclinique Bordeaux Nord Aquitaine | Terminated |
| Bordeaux, France, 33077 | |
| Centre Hospitalier de la Côte Fleurie | Recruiting |
| Cricqueboeuf, France, 14113 | |
| Contact: Jean-Paul Mabire, MD | |
| Principal Investigator: Jean-Paul Mabire, MD | |
| Clinique SSR "Les Rosiers" | Recruiting |
| Dijon, France, 21002 | |
| Contact: Bénédicte Vergès, MD +33 (0)3 80 44 50 34 b.verges@gsante.fr | |
| Principal Investigator: Bénédicte Vergès, MD | |
| Sub-Investigator: Marie-Cécile Blonde, MD | |
| Hôpital Bocage Central | Recruiting |
| Dijon, France, 21079 | |
| Contact: Jean-Christophe Eicher, MD | |
| Principal Investigator: Jean-Christophe Eicher, MD | |
| Hôpital Corentin Celton | Recruiting |
| Issy-les-Moulineaux, France, 92133 | |
| Contact: Marie-Christine Iliou, MD +33 (0)1 58 00 42 12 marie-christine.iliou@ccl.aphp.fr | |
| Principal Investigator: Marie-Christine Iliou, MD | |
| Hôpital de Joigny | Recruiting |
| Joigny, France, 89306 | |
| Contact: Yann Morvan, MD | |
| Principal Investigator: Yann Morvan, MD | |
| Clinique de la Mitterie | Terminated |
| Lomme, France, 59160 | |
| Centre Hospitalier Loire Vendée Ocean | Recruiting |
| Machecoul, France, 44270 | |
| Contact: Bruno Pavy, MD | |
| Principal Investigator: Bruno Pavy, MD | |
| Hôpital de jour de soins de suite et de réadaptation Léopold Bellan | Terminated |
| Paris, France, 75010 | |
| Clinique Saint-Yves | Recruiting |
| Rennes, France, 35044 | |
| Contact: Catherine Bossée-Pilon, MD, PhD bosseepilon@clinique-styves.fr | |
| Principal Investigator: Catherine Bossée-Pilon, MD | |
| Hôpital Intercommunal Sud Léman Valserine | Terminated |
| Saint Julien en Genevois, France, 74164 | |
| Centre de réadaptation cardiaque Leopold Bellan | Recruiting |
| Tracy-le-Mont, France, 60170 | |
| Contact: Mohamed Ghannem, MD | |
| Principal Investigator: Mohamed Ghannem, MD | |
| Les Grands Prés | Recruiting |
| Villeneuve-Saint-Denis, France, 77174 | |
| Contact: Philippe Meurin, MD | |
| Principal Investigator: Philippe Meurin, MD | |
Sponsors and Collaborators
French Cardiology Society
GERS
Bourgogne Association of Cardiology
Ile-de-France Association of Cardiology
Investigators
| Principal Investigator: | Marie Christine Iliou, MD | Hôpital Corentin Celton |
More Information
No publications provided
| Responsible Party: | Anissa Bouzamondo, French Society of Cardiology |
| ClinicalTrials.gov Identifier: | NCT01408875 History of Changes |
| Other Study ID Numbers: | 2007-03 |
| Study First Received: | August 2, 2011 |
| Last Updated: | April 8, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French Cardiology Society:
|
Chronic Heart Failure Cardiac rehabilitation Exercise training Peak VO2 Electrical myostimulation |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 13, 2013