Clinical trial NCT03548870: Transcutaneous Electrical Nerve Stimulation During Exercise in Patients With COPD
Official title: Effects of Transcutaneous Electrical Nerve Stimulation During Acute Aerobic Exercise in Patients With Chronic Obstructive Pulmonary Disease After Exacerbation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Physical Activity
Rehabilitation
TEN
Lead sponsor: Groupe Hospitalier du Havre
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: comparison of exercise tolerance
timeFrame: 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:
measure: Difference in peripheral muscle oxygenation
timeFrame: 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
measure: Difference in Dyspnea
timeFrame: 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
measure: Difference in Oxygen Saturation
timeFrame: 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
measure: Difference in Cardiac Frequency
timeFrame: 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
measure: Difference in muscular fatigue
timeFrame: 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
measure: Difference in oxygen consumption
timeFrame: 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
measure: Difference in carbon dioxide production
timeFrame: 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
measure: Difference in minute ventilation
timeFrame: 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
measure: Difference in tidal volume
timeFrame: 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
measure: Difference in respiratory rate
timeFrame: 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
measure: Difference in inspiratory capacity
timeFrame: 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
measure: Difference in respiratory quotient
timeFrame: 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
Other outcomes:
Locations:
city: Montivilliers
country: France
facility: Groupe hospitalier du Havre
Study officials:
References: