Transcutaneous Electrical Nerve Stimulation During Exercise in Patients With COPD

COPD Clinical Trial

— proTENS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03548870
• Other study ID #: 2017-A02290-53
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 23, 2021
• Est. completion date: October 8, 2024

Study information

• Verified date: October 2020
• Source: Groupe Hospitalier du Havre
• Contact: Prieur Guillaume, PT, MSc
• Phone: +33630038824
• Email: gprieur.kine[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• COPD
• Physical Activity
• Rehabilitation
• TEN

Intervention

Other:
• CWRT 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
• CWRT 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

Locations

Country	Name	City	State
France	Groupe hospitalier du Havre	Montivilliers

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier du Havre

Country where clinical trial is conducted

France, 

Outcome

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