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

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ClinicalTrials.gov Identifier: NCT03548870
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier du Havre

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

Condition or disease Intervention/treatment Phase
COPD Physical Activity Rehabilitation TEN Other: CWRT with low frequency transcutaneous electrical nerve stimulation Other: CWRT with sham-low frequency transcutaneous electrical nerve stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: sham transcutaneous electrical nerve stimulation
Primary Purpose: Treatment
Official Title: Effects of Transcutaneous Electrical Nerve Stimulation During Acute Aerobic Exercise in Patients With Chronic Obstructive Pulmonary Disease After Exacerbation
Actual Study Start Date : July 23, 2018
Estimated Primary Completion Date : June 8, 2020
Estimated Study Completion Date : August 8, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. comparison of exercise tolerance [ 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 ]
    Comparison of endurance time (Tlim, in second) during constant workload testing (CWRET) under 2 conditions


Secondary Outcome Measures :
  1. Difference in peripheral muscle oxygenation [ 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 ]
    Muscle oxygenation (arbitrary unit) will be evaluated using Near-infrared spectroscopy technology.

  2. Difference in Dyspnea [ 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 using Modified Borg Scale (0 - 10 points) 0=no dyspnea ; 10 = maximal effort

  3. Difference in Oxygen Saturation [ 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 (%) using a pulse oximetry (SpO2)

  4. Difference in Cardiac Frequency [ 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 Frequence (bpm) using a pulse oximetry

  5. Difference in muscular fatigue [ 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 muscular fatigue using Modified Borg Scale (0 - 10 points) 0=no muscular fatigue ; 10 = maximal effort

  6. Difference in oxygen consumption [ 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 consumption (milliliters per minute) will be measured breath-by-breath using a computer-based exercise system

  7. Difference in carbon dioxide production [ 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 carbon dioxide production (milliliters per minute) will be measured breath-by-breath using a computer-based exercise system

  8. Difference in minute ventilation [ 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 minute ventilation (liters per minute) will be measured breath-by-breath using a computer-based exercise system

  9. Difference in tidal volume [ 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 tidal volume (Liters) will be measured breath-by-breath using a computer-based exercise system

  10. Difference in respiratory rate [ 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 respiratory rate (cycles per minute) will be measured breath-by-breath using a computer-based exercise system

  11. Difference in inspiratory capacity [ 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 inspiratory capacity (Liters) will be measured breath-by-breath using a computer-based exercise system

  12. Difference in respiratory quotient [ 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 respiratory quotient (ratio) will be measured breath-by-breath using a computer-based exercise system



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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548870


Contacts
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Contact: Prieur Guillaume, PT, MSc +33630038824 gprieur.kine@gmail.com
Contact: Prieur Guillaume, PT, MSc +33630038824

Locations
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France
Groupe hospitalier du Havre Recruiting
Montivilliers, France, 76290
Contact: Prieur Guillaume    +33630038824    guillaume.prieur@ch-havre.fr   
Sponsors and Collaborators
Groupe Hospitalier du Havre

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Responsible Party: Groupe Hospitalier du Havre
ClinicalTrials.gov Identifier: NCT03548870     History of Changes
Other Study ID Numbers: 2017-A02290-53
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases