Transcutaneous Electrical Nerve Stimulation During Exercise in Patients With COPD

Not Applicable

Not yet recruiting

• Conditions: Physical Activity; TEN; COPD; Rehabilitation
• Interventions: Other: CWRT with low frequency transcutaneous electrical nerve stimulation; Other: CWRT with sham-low frequency transcutaneous electrical nerve stimulation

• Registration Number: NCT03548870
• Lead Sponsor: Groupe Hospitalier du Havre

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-06-06
• Study First Posted: 2018-06-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-10-23
• Study Start: 2021-10-23
• Primary Completion: 2023-10-08
• Study Completion: 2024-10-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test with TENS	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	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 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 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 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 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 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

Trial Locations

Locations (1)

Groupe hospitalier du Havre; 🇫🇷 Montivilliers, France