Status:
COMPLETED
Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure
Lead Sponsor:
French Cardiology Society
Collaborating Sponsors:
Gulf Estuarine Research Society (GERS)
Bourgogne Association of Cardiology
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18-75 years
Phase:
NA
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 h...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT01408875
Start Date
October 1 2011
End Date
January 1 2014
Last Update
March 9 2015
Active Locations (14)
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1
Centre de réadaptation spécialisé Saint Luc
Abreschviller, France, 57560
2
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33077
3
Centre Hospitalier de la Côte Fleurie
Cricquebœuf, France, 14113
4
Clinique SSR "Les Rosiers"
Dijon, France, 21002