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OpenTrials
Completed

NCT Number: NCT02046707

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

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.

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Key information

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Dijon

Dijon, 21079, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

initial evaluation

Other

Period of cardiac rehabilitation

Other

final evaluation

Other

Concentric and eccentric exercise sessions

Other

Primary outcomes

  1. Evolution of performance in the 6-minute walk test between the initial assessment and the final assessment of a reconditioning programme

    Time frame: 12 weeks

Secondary outcomes

  1. Evolution of functional and physiological capacities and tolerance criteria

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
First posted
Jan 28, 2014
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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