Transcutaneous Electrical Nerve Stimulation During Exercise in Patients With COPD (proTENS)

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

Study Overview

• Status: Terminated
• Conditions: Physical Activity; Rehabilitation; COPD; TEN
• Intervention / Treatment: Other: CWRT with low frequency transcutaneous electrical nerve stimulation; Other: CWRT with sham-low frequency transcutaneous electrical nerve stimulation

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montivilliers, France, 76290
    • Groupe Hospitalier Du Havre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test with TENS; 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; 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
Sham Comparator: Test with sham-TENS; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier du Havre

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2021
• Primary Completion (Actual): October 8, 2023
• Study Completion (Actual): October 8, 2024

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 7, 2018

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Behavior; Pulmonary Disease, Chronic Obstructive; Motor Activity
• Other Study ID Numbers: 2017-A02290-53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No