NCT01408875

Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: French Cardiology Society · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if addition of low frequency electro-myo-stimulation to cardiac rehabilitation is effective to improve exercise capacity and/or muscular strength in chronic heart failure patients.

Detailed description

In chronic heart failure, low exercise capacity is due, in part, to peripheral muscles abnormalities. Exercise training performed during cardiac rehabilitation improves exercise tolerance measured by cardiopulmonary exercise test. Low frequency electromyostimulation (EMS) was proposed as an alternative to exercise training (ET) in this population. However, the effectiveness of the combination (EMS +ET) compared with ET alone is not proved. The main objective is to compare exercise capacity judged by peak VO2 after treatment by ET alone versus EMS+ET. The secondary end points are results on sub maximal parameters, muscular resistance, quality of life and effectiveness regarding clinical sub-groups. This study is a controlled, randomized, multicentric (14 centres) designed to include 90 patients by group in two years period. Inclusion criteria are: CHF patients , NYHA class II to IIIb, with LVEF \< 40% referred to complete a cardiac rehabilitation program. All the patients benefit from a comprehensive cardiac rehabilitation program including educational program, therapeutical optimisation and exercise training for 20 sessions, 3 to 5 days a week. The group of patients randomized for additional EMS has 20 sessions of 1 hour electrical quadricipital myostimulation.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DEVICE	Low electrical myostimulation	The group of patients randomized for additional EMS will have 20 sessions of 1 hour electrical quadricipital myostimulation.

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2011-08-03
• Last updated: 2015-03-09

Locations

14 sites across 1 country: France