COPD, Physical Activity, Rehabilitation, TEN
Conditions
Brief summary
Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of chronic obstructive pulmonary disease (COPD). However, its implementation is challenging particularly as regard exercise training. Several studies showed that transcutaneous electrical nerve stimulation (TENS) could improve dyspnea and pulmonary function. The aim of this study is to assess the acute effect of TENS on exercise tolerance in post-exacerbation COPD patients
Interventions
OTHERCWRT with low frequency transcutaneous electrical nerve stimulation
4 self adhesive surface electrodes will be positioned by pair on quadriceps. Patients will have a low frequency TENS for 20 min at rest. During this period, intensity will be increased every 5 minutes to the maximum tolerated by the patient (below pain threshold, sensation strong but comfortable). Thereafter, intensity is not increased anymore during the test. Current characteristics : Rehab 400, CefarCompex 5Hz 200 µs frequency bidirectional
OTHERCWRT with sham-low frequency transcutaneous electrical nerve stimulation
4 self adhesive surface electrodes are positioned by pair on quadriceps. Patients will have a sham-low frequency TENS for 20 min at rest. During this period, intensity will be increased for 1 minute to the maximum tolerated by the patient. After this procedure, intensity will be progressively setted back to 1mA. Current characteristics : Rehab 400, CefarCompex 5Hz 200 µs frequency bidirectional
Sponsors
Groupe Hospitalier du Havre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
sham transcutaneous electrical nerve stimulation
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* a diagnosis of COPD
Exclusion criteria
* exercise contraindication Any musculoskeletal problems, cardiovascular or * neurological comorbidities that limits exercise. * pH \< 7,35 * Body temperature \> 38°C * cardiac frequency \> 100 bpm at rest * systolic blood pressure \< 100 mmHg * exacerbation during the study * heart pace-maker or defibrillator * Opiate treatment during the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| comparison of exercise tolerance | two CWRET will be carried out in different days, separate from 24 hours minimum for a total time frame of 5 days maximum | Comparison of endurance time (Tlim, in second) during constant workload testing (CWRET) under 2 conditions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in peripheral muscle oxygenation | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise | Muscle oxygenation (arbitrary unit) will be evaluated using Near-infrared spectroscopy technology. |
| Difference in Dyspnea | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise | Difference in dyspnea using Modified Borg Scale (0 - 10 points) 0=no dyspnea ; 10 = maximal effort |
| Difference in Oxygen Saturation | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise | Difference in Oxygen Saturation (%) using a pulse oximetry (SpO2) |
| Difference in Cardiac Frequency | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise | Difference in Cardiac Frequence (bpm) using a pulse oximetry |
| Difference in muscular fatigue | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise | Difference in muscular fatigue using Modified Borg Scale (0 - 10 points) 0=no muscular fatigue ; 10 = maximal effort |
| Difference in oxygen consumption | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise | Difference in oxygen consumption (milliliters per minute) will be measured breath-by-breath using a computer-based exercise system |
| Difference in carbon dioxide production | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise | Difference in carbon dioxide production (milliliters per minute) will be measured breath-by-breath using a computer-based exercise system |
| Difference in minute ventilation | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise | Difference in minute ventilation (liters per minute) will be measured breath-by-breath using a computer-based exercise system |
| Difference in tidal volume | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise | Difference in tidal volume (Liters) will be measured breath-by-breath using a computer-based exercise system |
| Difference in respiratory rate | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise | Difference in respiratory rate (cycles per minute) will be measured breath-by-breath using a computer-based exercise system |
| Difference in inspiratory capacity | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise | Difference in inspiratory capacity (Liters) will be measured breath-by-breath using a computer-based exercise system |
| Difference in respiratory quotient | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise | Difference in respiratory quotient (ratio) will be measured breath-by-breath using a computer-based exercise system |
Countries
France
Outcome results
None listed