COPD Clinical Trial
— proTENSOfficial title:
Effects of Transcutaneous Electrical Nerve Stimulation During Acute Aerobic Exercise in Patients With Chronic Obstructive Pulmonary Disease After Exacerbation
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
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | October 8, 2024 |
Est. primary completion date | October 8, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Groupe hospitalier du Havre | Montivilliers |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier du Havre |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | comparison of exercise tolerance | Comparison of endurance time (Tlim, in second) during constant workload testing (CWRET) under 2 conditions | two CWRET will be carried out in different days, separate from 24 hours minimum for a total time frame of 5 days maximum | |
Secondary | Difference in peripheral muscle oxygenation | Muscle oxygenation (arbitrary unit) will be evaluated using Near-infrared spectroscopy technology. | 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 | |
Secondary | Difference in Dyspnea | Difference in dyspnea using Modified Borg Scale (0 - 10 points) 0=no dyspnea ; 10 = maximal effort | 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 | |
Secondary | Difference in Oxygen Saturation | Difference in Oxygen Saturation (%) using a pulse oximetry (SpO2) | 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 | |
Secondary | Difference in Cardiac Frequency | Difference in Cardiac Frequence (bpm) using a pulse oximetry | 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 | |
Secondary | Difference in muscular fatigue | Difference in muscular fatigue using Modified Borg Scale (0 - 10 points) 0=no muscular fatigue ; 10 = maximal effort | 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 | |
Secondary | Difference in oxygen consumption | Difference in oxygen consumption (milliliters per minute) will be measured breath-by-breath using a computer-based exercise system | 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 | |
Secondary | Difference in carbon dioxide production | Difference in carbon dioxide production (milliliters per minute) will be measured breath-by-breath using a computer-based exercise system | 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 | |
Secondary | Difference in minute ventilation | Difference in minute ventilation (liters per minute) will be measured breath-by-breath using a computer-based exercise system | 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 | |
Secondary | Difference in tidal volume | Difference in tidal volume (Liters) will be measured breath-by-breath using a computer-based exercise system | 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 | |
Secondary | Difference in respiratory rate | Difference in respiratory rate (cycles per minute) will be measured breath-by-breath using a computer-based exercise system | 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 | |
Secondary | Difference in inspiratory capacity | Difference in inspiratory capacity (Liters) will be measured breath-by-breath using a computer-based exercise system | 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 | |
Secondary | Difference in respiratory quotient | Difference in respiratory quotient (ratio) will be measured breath-by-breath using a computer-based exercise system | 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 |
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