Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COPD
- Sponsor
- University Hospital, Brest
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- functional capacity of the lower limb muscles
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
The aim of this study is to evaluate the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer as part of pulmonary rehabilitation program , in patients with severe or very severe COPD , according to GOLD with BODE index ≥ 5 .
Detailed Description
It's a prospective ,multicentre,randomised, single-blind study which compare the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer training as part of pulmonary rehabilitation program. The program lasts from 3 to 4 weeks. 102 patients will included, diagnosed with COPD stages GOLD III and IV, and BODE index ≥ 5. The commun program: training protocol performed on treadmill,quadriceps resistance training,patient therapeutic education,collective gymnastics,relaxation, session psychological care, smoking cessation program and nutritional management if necessary. The primary criterion is the one minute sit to stand test.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with COPD stage 3 or 4, with BODE index ≥ 5
- •Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix or in the center "Les Acacias" of briançon, with a 3 at 4 weeks pulmonary rehabilitation course;
Exclusion Criteria
- •FEV ≥ 50%
- •Pneumonectomy, Lobectomy less than 6 months
- •Contraindications to muscle electrostimulation quadriceps
- •Absence of written consent
- •Inability to follow the respiratory rehabilitation program in its entirety
- •People equipped with electronic devices such as pacemakers and intracardiac defibrillators
- •Skin lesions and infectious foci on the electrode placement area.
Outcomes
Primary Outcomes
functional capacity of the lower limb muscles
Time Frame: 21 - 4 days / +7 days
Measure of the functional capacity of the lower limb muscles with the "1 minute Sit To Stand Test "
Secondary Outcomes
- Maximal isometric voluntary quadriceps strength assessment(21 - 4 days / +7 days)
- isometric voluntary quadriceps endurance assessment(21 - 4 days / +7 days)
- Dyspnea Assessment with MRC Scale(21 - 4 days / +7 days)
- assessment of exercise capacity(21 - 4 days / +7 days)
- Quality of Life Assessment(21 - 4 days / +7 days)
- Dyspnea Assessment with Borg scale(21 - 4 days / +7 days)
- Dyspnea Assessment with Dyspnea 12 questionnary(21 - 4 days / +7 days)
- Inspiratory capacity (in litres) by spirometry(21 - 4 days / +7 days)