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Clinical Trials/NCT02046707
NCT02046707
Completed
N/A

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

Centre Hospitalier Universitaire Dijon1 site in 1 country71 target enrollmentAugust 29, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Heart Failure
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
71
Locations
1
Primary Endpoint
Evolution of performance in the 6-minute walk test between the initial assessment and the final assessment of a reconditioning programme
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 29, 2014
End Date
March 23, 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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\>
  • 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

  • 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...).

Outcomes

Primary Outcomes

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

  • Evolution of functional and physiological capacities and tolerance criteria(12 weeks)

Study Sites (1)

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