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

NCT ID: NCT02046707

Last Updated: 2019-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-29

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Heart Failure Reconditioning to Effort

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Patients with chronic heart failure

Group Type EXPERIMENTAL

initial evaluation

Intervention Type OTHER

Period of cardiac rehabilitation

Intervention Type OTHER

final evaluation

Intervention Type OTHER

Controls

Group Type OTHER

Concentric and eccentric exercise sessions

Intervention Type OTHER

Interventions

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initial evaluation

Intervention Type OTHER

Period of cardiac rehabilitation

Intervention Type OTHER

final evaluation

Intervention Type OTHER

Concentric and eccentric exercise sessions

Intervention Type OTHER

Eligibility Criteria

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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.


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.

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…).
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Dijon

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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CASILLAS Fondation Av 2008

Identifier Type: -

Identifier Source: org_study_id

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