Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, electrical stimulation, Rehabilitation, exercise test
Brief summary
Quadricipital electrical stimulation added to respiratory rehabilitation in COPD patients. Quadricipital electrical stimulation (ES) in chronic obstructive pulmonary disease (COPD) patients has been demonstrated to improve both dyspnea and physical status. The aim of our study is to demonstrate that ES added to respiratory rehabilitation program induces a greater improvement on exercise tolerance in such patients. Design : 160 patients with severe COPD will be randomly assigned to 2 groups : either rehabilitation program (group 1), either ES and rehabilitation program (group 2). In both groups, rehabilitation program comprises endurance training, 18 - 24 sessions (6 - 8 weeks), health education, global muscular strengthening. In group 2, bilateral quadricipital electrical stimulation 30 min sessions is added 5 days / week. Subjects : COPD patients with FEV1 \< 60% pred, FEV1/VC \< 70%, and TLC \> 80%, with dyspnea, in stable conditions, and 18 \> BMI \< 35 kg/m² . Intervention : 6 min walking distance, incremental exercise test data (aerobic capacity, work rate, ventilatory threshold), physical activity with activity monitor, health related quality of life will be determined before and after training. Abbreviations : FEV1 = forced expiratory volume in 1 sec; VC = vital capacity; TLC = total lung capacity; BMI = body mass index.
Interventions
DEVICEgroup 2 : quadricipital electrical stimulation
bilateral quadricipital electrical stimulation 5 sessions a week, (6 - 8 weeks)
OTHERpulmonary rehabilitation
exercise training, 3 to 5 times per week, 8 weeks
Bilateral quadricipital electrical stimulation 30 min, 5 times per week, 8 weeks,in addition to pulmonary rehabilitation
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects : COPD patients with FEV1 \< 60% pred, FEV1/VC \< 70%, and TLC \> 80%, with dyspnea, in stable conditions, and 18 \> BMI \< 35 kg/m²
Exclusion criteria
* BMI 18 \< or \> 35 kg/m² * Pregnant women * peripheral neuropathy * cardio respiratory incremental test contra-indication * evolutive cancer * cardiac or cerebral pace maker, implanted cardio defibrillator * no informed consent given
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 minute walking distance | From 6 to 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incremental cardio pulmonary exercise test | From 6 to 8 weeks | Aerobic capacity, maximal achieved work rate, ventilatory threshold |
Countries
France
Outcome results
None listed