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

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046707
• Other study ID #: CASILLAS Fondation Av 2008
• Status: Completed
• Phase: N/A
• Start date: August 29, 2014

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. primary completion date: March 23, 2015
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Reconditioning to Effort

Intervention

Other:
• initial evaluation

• Period of cardiac rehabilitation

• final evaluation

• Concentric and eccentric exercise sessions

Locations

Country	Name	City	State
France	CHU de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of performance in the 6-minute walk test between the initial assessment and the final assessment of a reconditioning programme		12 weeks
Secondary	Evolution of functional and physiological capacities and tolerance criteria		12 weeks