NCT03548870 - Transcutaneous Electrical Nerve Stimulation During Exercise in Patients With COPD | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

2

Conditions

COPD Physical Activity Rehabilitation TEN

Interventions

CWRT with low frequency transcutaneous electrical nerve stimulationOTHER

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 stimulationOTHER

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

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Groupe hospitalier du Havre

Montivilliers, France

Outcomes

Primary Outcomes

comparison of exercise tolerance

Comparison of endurance time (Tlim, in second) during constant workload testing (CWRET) under 2 conditions

Time frame: 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

Difference in peripheral muscle oxygenation

Muscle oxygenation (arbitrary unit) will be evaluated using Near-infrared spectroscopy technology.

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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