Transcutaneous Electrical Nerve Stimulation During Exercise in Patients With COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-23

Study Completion Date

2024-10-08

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

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Detailed Description

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Conditions

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COPD Physical Activity Rehabilitation TEN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

sham transcutaneous electrical nerve stimulation

Study Groups

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Test with TENS

Patients will perform one Constant Work-Rate Exercise Test at 80% of maximum workload with low frequency TENS

Group Type EXPERIMENTAL

CWRT with low frequency transcutaneous electrical nerve stimulation

Intervention Type 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 sham-TENS

Patients will perform one Constant Work-Rate Exercise Test at 80% of maximum workload with low frequency sham-TENS

Group Type SHAM_COMPARATOR

CWRT with sham-low frequency transcutaneous electrical nerve stimulation

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No