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.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure; Reconditioning to Effort
• Intervention / Treatment: Other: initial evaluation; Other: Period of cardiac rehabilitation; Other: final evaluation; Other: Concentric and eccentric exercise sessions

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • CHU de DIJON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Controls	Other: Concentric and eccentric exercise sessions
EXPERIMENTAL: Patients with chronic heart failure	Other: initial evaluation; Other: Period of cardiac rehabilitation; Other: final evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evolution of performance in the 6-minute walk test between the initial assessment and the final assessment of a reconditioning programme	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Evolution of functional and physiological capacities and tolerance criteria	12 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 29, 2014
• Primary Completion (ACTUAL): March 23, 2015

Study Registration Dates

• First Submitted: January 20, 2014
• First Submitted That Met QC Criteria: January 24, 2014
• First Posted (ESTIMATE): January 28, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CASILLAS Fondation Av 2008