Transcutaneous Electrical Nerve Stimulation During Exercise in Patients With COPD

Study Overview
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Brief Summary
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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

Official Title
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Effects of Transcutaneous Electrical Nerve Stimulation During Acute Aerobic Exercise in Patients With Chronic Obstructive Pulmonary Disease After Exacerbation

Conditions
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TEN, Physical Activity, COPD, Rehabilitation

Intervention / Treatment
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* Other: CWRT with low frequency transcutaneous electrical nerve stimulation
* Other: CWRT with sham-low frequency transcutaneous electrical nerve stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test with TENS<br>Patients will perform one Constant Work-Rate Exercise Test at 80% of maximum workload with low frequency TENS | Other: CWRT with low frequency transcutaneous electrical nerve stimulation<br>* 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<br>|
| Sham Comparator: Test with sham-TENS<br>Patients will perform one Constant Work-Rate Exercise Test at 80% of maximum workload with low frequency sham-TENS | Other: CWRT with sham-low frequency transcutaneous electrical nerve stimulation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |