COPD
Conditions
Keywords
COPD pulmonary rehabilitation, neuromuscular electrical stimulation, sit to stand test COPD, quadriceps strengthening
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.
Interventions
DEVICEneuromuscular electrical stimulation
quadriceps strenghthening with neuromuscular electrical stimulation (medical device)
DEVICEcycle ergometer training
quadriceps strenghthening with cycle ergometer training
excercise training on treadmill
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| functional capacity of the lower limb muscles | 21 - 4 days / +7 days | Measure of the functional capacity of the lower limb muscles with the 1 minute Sit To Stand Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| isometric voluntary quadriceps endurance assessment | 21 - 4 days / +7 days | Measure of isometric voluntary quadriceps endurance assessment with handheld dynamometer |
| assessment of exercise capacity | 21 - 4 days / +7 days | Six minute walking test for assessing exercise capacity |
| Quality of Life Assessment | 21 - 4 days / +7 days | COPD assessment test for assessing quality of life |
| Maximal isometric voluntary quadriceps strength assessment | 21 - 4 days / +7 days | Quadriceps strength assessment with handheld dynamometer |
| Dyspnea Assessment with MRC Scale | 21 - 4 days / +7 days | Measure of dyspnea with Medical Research Council Dyspnea Scale |
| Dyspnea Assessment with Dyspnea 12 questionnary | 21 - 4 days / +7 days | Measure of dyspnea with Dyspnea 12 questionnary |
| Inspiratory capacity (in litres) by spirometry | 21 - 4 days / +7 days | Measure of inspiratory capacity (in litres) by spirometry |
| Dyspnea Assessment with Borg scale | 21 - 4 days / +7 days | Measure of dyspnea with Borg scale at the end of the six minute walking test |
Countries
France
Outcome results
None listed