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Evaluation of the Effects of Eccentric Muscle Training Versus Conventional Concentric Training in Chronic Heart Failure

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Chronic Heart Failure
Reconditioning to Effort

Treatments

Other: Period of cardiac rehabilitation
Other: final evaluation
Other: Concentric and eccentric exercise sessions
Other: initial evaluation

Study type

Interventional

Funder types

Other

Identifiers

NCT02046707
CASILLAS Fondation Av 2008

Details and patient eligibility

About

This is a single-centre open randomized parallel-group study. Patients will be selected at random to be included in group 1: eccentric rehabilitation or group 2: conventional rehabilitation.

In addition, a group of healthy volunteers aged between 20 and 85 years will also be recruited. This group will make it possible to evaluate, during the two exercise sessions, mechanisms of adaptation linked to eccentric exercise vs concentric exercise.

Enrollment

71 patients

Sex

All

Ages

45 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients :

  • Patients who have provided written informed consent
  • Patients with national health insurance cover
  • Men or women aged between 45 and 85 years with stabilized chronic heart failure (ischemic or dilated cardiopathy) for at least one month, New York Heart Association stage> 2.
  • Echocardiographic left ventricular ejection fraction (Simpson method) < 45% OR N-terminal-ProBNP > 3 x upper limit of normal* (*= 125pg/ml for the CHU laboratory).
  • First period of rehabilitation for chronic heart failure.

Healthy volunteers:

  • Subjects who have provided written informed consent
  • Subjects with national health insurance cover
  • Men or women aged between 18 and 85 years.

Exclusion criteria

Patients:

  • persons without national health insurance cover
  • Severe obstructive cardiopathy,
  • severe aortic valve stenosis,
  • severe progressive heart rhythm or conduction disorders not corrected with a pacemaker, discovered at the initial effort test
  • intra-cavitary thrombus,
  • severe pulmonary artery hypertension (systolic pulmonary arterial hypertension >70mmHg),
  • recent history of venous trombo-embolism (last 3 months),
  • impaired executive function making it impossible to understand and follow reconditioning programme (Mini Mental Test < 24),
  • heart transplant,
  • associated medical disorders that could predominately impair functional capacity compared with the chronic heart failure (examples: respiratory insufficiency, non-stabilized metabolic disorders such as progressive kidney failure, severe asthenia related to a severe non-stabilized disorder such as neoplasia, systemic disease...).

associated chronic motor deficit of a neurological origin (example: sequelae of a cerebrovascular accident), an osteo-articular origin (example: impairment due to Rheumatoid arthritis), of a peripheral vascular disease (example: peripheral artery disease, venous disease, lymphedema) will not be included in the exclusion criteria provided thay are compatible with the level of physical ability defined in the inclusion criteria. The presence of an implantable pacemaker and/or defibrillator will not be an exclusion criterion

Healthy volunteers:

  • persons without national health insurance cover
  • Any organic disorder whatever its nature (cardiac, respiratory, neurological, orthopedic, ...) that could affect adaptation to effort or is a contra-indication for physical activity.

Trial design

71 participants in 2 patient groups

Patients with chronic heart failure
Experimental group
Treatment:
Other: final evaluation
Other: Period of cardiac rehabilitation
Other: initial evaluation
Controls
Other group
Treatment:
Other: Concentric and eccentric exercise sessions

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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