Transcutaneous Electrical Nerve Stimulation During Exercise in Patients With COPD

NCT03548870 | Terminated

• 1 other identifier: 2017-A02290-53
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

COPD; Physical Activity; Rehabilitation; TEN

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

• 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 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 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 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

Study Arms (2)

Test with TENS

EXPERIMENTAL

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

Test with sham-TENS

SHAM COMPARATOR

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

Interventions

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

Test with TENS

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

Test with sham-TENS

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a diagnosis of COPD

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier du Havre: lead

Study Sites (1)

Groupe hospitalier du Havre

Montivilliers, 76290, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: sham transcutaneous electrical nerve stimulation
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 7, 2018
• Study Start: October 23, 2021
• Primary Completion: October 8, 2023
• Study Completion: October 8, 2024
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

FR (1)