Effects of Transcutaneous Electrical Nerve Stimulation During Acute Aerobic Exercise in Patients With Chronic Obstructive Pulmonary Disease After Exacerbation
| Registry | NCT03548870, acronym proTENS |
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| Status | Terminated - not enough recruitment |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, crossover, masking: triple, treatment |
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| Enrollment | 2 (Actual) |
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| Sponsor | Groupe Hospitalier du Havre (Other) |
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| Conditions | COPD, Physical Activity, Rehabilitation, TEN |
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| Interventions | CWRT with low frequency transcutaneous electrical nerve stimulation, CWRT with sham-low frequency transcutaneous electrical nerve stimulation (Other) |
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| Dates | start 2021-10-23, primary completion 2023-10-08, completion 2024-10-08, first posted 2018-06-07, last updated 2026-01-21 |
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| Locations | 1 site in France |
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Related Papers Related Patents Related Grants Related Experts
All trials for COPD All trials for Physical Activity All trials of CWRT with low frequency transcutaneous electrical nerve stimulation All trials of CWRT with sham-low frequency transcutaneous electrical nerve stimulation
-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
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Test with TENS | Experimental | Other: CWRT with low frequency transcutaneous electrical nerve stimulation | Patients will perform one Constant Work-Rate Exercise Test at 80% of maximum workload with low frequency TENS |
| Test with sham-TENS | Sham comparator | Other: CWRT with sham-low frequency transcutaneous electrical nerve stimulation | Patients will perform one Constant Work-Rate Exercise Test at 80% of maximum workload with low frequency sham-TENS |
- CWRT with low frequency transcutaneous electrical nerve stimulation (Other): 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
- CWRT with sham-low frequency transcutaneous electrical nerve stimulation (Other): 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
+Outcome measures
Primary outcomes
- 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 outcomes
- 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
+Eligibility
Sex: All, ages: 35 Years to 80 Years
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
+Locations (1)
| Facility | City | Country | Status |
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| Groupe hospitalier du Havre | Montivilliers | France | |