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Effects of Lumbar Transcutaneous Electrical Nerve Stimulation on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease (LENS-REHAB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03312322
Recruitment Status : Completed
First Posted : October 17, 2017
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
ADIR Association

Brief Summary:

Chronic obstructive pulmonary disease is a leading cause of morbidity and mortality worldwide.

Pulmonary rehabilitation effectively improves outcomes in patients with chronic respiratory disease. There is a link between training intensity and physiological improvements following pulmonary rehabilitation. However, high intensity training is not sustainable for every patients.

Therefore, actual strategies for pulmonary rehabilitation aimed at decreasing dyspnea to improve muscle work.

Electrical muscle stimulation is widely used during rehabilitation to promote muscle function recovery. Transcutaneous electrical nerve stimulation was recently used to relief dyspnea and improve pulmonary function in patients with chronic respiratory disease. Moreover, spinal anesthesia with fentanyl has been shown to be effective in improving exercise tolerance in patients with chronic obstructive pulmonary disease (inhibiting group III and IV muscle afferents). As transcutaneous electrical muscle stimulation stimulates the same receptors in the spinal cord dorsal horn as fentanyl, it is hypothesized that it could also improve exercise capacity.

Therefore, the aim of this study is to assess wether transcutaneous electrical stimulation (high or low frequency) is effective in improving exercise capacity in patients with severe to very severe chronic obstructive pulmonary disease.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: High-frequency transcutaneous electrical nerve stimulation Other: Low-frequency transcutaneous electrical nerve stimulation Other: Sham transcutaneous electrical nerve stimulation Not Applicable

Detailed Description:

Design : cross-over.

Patients will perform three constant workload testing (CWT) on different days under three different conditions. The intervention during the tests will be randomly assigned (concealed allocation) :

  • Sham transcutaneous electrical nerve stimulation ;
  • High-frequency transcutaneous electrical nerve stimulation ;
  • Low-frequency transcutaneous electrical nerve stimulation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Three constant workload testing will be performed on three different days.

Every test will be carried out with a different condition :

  • Sham transcutaneous electrical nerve stimulation;
  • High-frequency transcutaneous electrical nerve stimulation;
  • Low-frequency transcutaneous electrical nerve stimulation.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Sham placebo will be used to blind patient. The outcome assessor will be invited to join the room after the experimental condition is installed.
Primary Purpose: Treatment
Official Title: Effects of Lumbar Transcutaneous Electrical Nerve Stimulation on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease : A Pilot Study
Actual Study Start Date : December 12, 2017
Actual Primary Completion Date : October 26, 2018
Actual Study Completion Date : October 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CWT with high-frequency electrical nerve stimulation
This study has a cross-over design. Patients will achieve CWT with either sham, high-frequency or low-frequency lumbar transcutaneous electrical nerve stimulation in a randomised order.
Other: High-frequency transcutaneous electrical nerve stimulation

4 self adhesive surface electrodes are positioned by pair at the L3-L4 level, laterally.

Stimulation is setted at rest, 10min before constant workload testing. During this period, intensity is increased every 3minutes to the maximum tolerated by the patient (pain threshold). Thereafter, intensity is not increased anymore during the test.

It is explained to the patient that he might or no experience the electrical stimulation sensation.

Current characteristics : 100Hertz, 100ms, bidirectional. Constant workload testing : 60-70rpm ; 75% Wpic ; up to exhaustion or rpm < 60 during more than 10s.


Experimental: CWT with low-frequency electrical nerve stimulation
This study has a cross-over design. Patients will achieve CWT with either sham, high-frequency or low-frequency lumbar transcutaneous electrical nerve stimulation in a randomised order.
Other: Low-frequency transcutaneous electrical nerve stimulation

4 self adhesive surface electrodes are positioned by pair at the L3-L4 level, laterally.

Stimulation is setted at rest, 10min before constant workload testing. During this period, intensity is increased every 3minutes to the maximum tolerated by the patient (pain threshold). Thereafter, intensity is not increased anymore during the test.

It is explained to the patient that he might or no experience the electrical stimulation sensation.

Current characteristics : 4Hertz, 100ms, bidirectional. Constant workload testing : 60-70rpm ; 75% Wpic ; up to exhaustion or rpm < 60 during more than 10s.


Experimental: CWT with sham electrical nerve stimulation
This study has a cross-over design. Patients will achieve CWT with either sham, high-frequency or low-frequency lumbar transcutaneous electrical nerve stimulation in a randomised order.
Other: Sham transcutaneous electrical nerve stimulation
The procedure is the same as high-frequency transcutaneous electrical stimulation but intensity is progressively setted back to 1mA (over a 45sec period) after every increment so that constant workload testing is performed with 1mA.




Primary Outcome Measures :
  1. Comparison of endurance time (Tlim, in second) during constant workload testing (CWT) under 3 conditions. [ Time Frame: The outcome will be measured after every CWT. Data will be continuously collected during the tests. The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. ]
    Patients will achieve 3 constant workload testing under 3 different conditions (sham lumbar transcutaneous electrical nerve stimulation, high-frequency lumbar electrical nerve stimulation and low-frequency lumbar transcutaneous electrical nerve stimulation). Endurance time (sec) will be recorded at the end of every test. Endurance time will be compared to assess how the condition will influence exercice performance.


Secondary Outcome Measures :
  1. Dyspnea during CWT using modified Borg Scale (0-10). [ Time Frame: The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests ]
    The dyspnea will be assessed every 30sec during CWT. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

  2. Exhaustion during CWT using modified Borg Scale (0-10). [ Time Frame: The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests.] ]
    The exhaustion will be assessed every 30sec during CWT. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

  3. Heart rate (rpm) during CWT. [ Time Frame: The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected ]
    Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

  4. Blood pressure (mmHg) before and after every CWT. [ Time Frame: The outcome will be assessed before and after every CWT. The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. ]
  5. Oxygen saturation (SpO2, %) during CWT. [ Time Frame: The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected ]
    Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

  6. O2 consumption (VO2, mL/kg/min) during CWT. [ Time Frame: The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected ]
    Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

  7. Exercise ventilation (VE, L/min) during CWT. [ Time Frame: The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected ]
    Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

  8. Tidal Volume (Vt, L) during CWT. [ Time Frame: The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected ]
    Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

  9. Respiratory Rate (RR, rpm) during CWT. [ Time Frame: The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected ]
    Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

  10. Variation of total hemoglobin (THb) using near infra red spectroscopy. [ Time Frame: The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected ]
    Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

  11. Variation of total desoxy-hemoglobin (HHb) using near infra red spectroscopy. [ Time Frame: The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected ]
    Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

  12. Variation of total oxy-hemoglobin (HbO2) using near infra red spectroscopy. [ Time Frame: The outcome will be measured during every CWT.The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected ]
    Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test).

  13. Intensity of electrical stimulation (mA) reached during every CWT. [ Time Frame: The outcome will be measured after every CWT. The 3 CWT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years;
  • Chronic obstructive pulmonary disease Gold III-IV;
  • Eligible for pulmonary rehabilitation;
  • Never used electrical stimulation.

Non-inclusion Criteria:

  • Pregnant woman or likely to be;
  • Patient under guardianship;
  • History of epilepsy, heart pace-maker or defibrillator, inguinal or abdominal hernia;
  • Recent lumbar surgery or skin lesion;
  • Allergy to surface electrodes;
  • Lumbar sensitivity impairment;
  • Opiate treatment during the last 3 months.

Exclusion Criteria:

  • Acute exacerbation of chronic obstructive pulmonary disease

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): NCT03312322


Locations
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France
Groupe Hospitalier du Havre
Le Havre, France, 76600
Sponsors and Collaborators
ADIR Association
Investigators
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Principal Investigator: Antoine Cuvelier, Prof, PhD CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
Study Chair: Jean-François Muir, Prof, PhD CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; ADIR Association, Bois-Guillaume, France
Study Chair: Catherine Tardif, MD CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Study Chair: Catherine Viacroze, MD CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
Study Chair: David Debeaumont, MD CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Study Chair: Maxime Patout, MD, MsC CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
Study Chair: Lamia Bouchra, Prof, PhD UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Study Chair: Jean Quieffin, MD UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Study Chair: Guillaume Prieur, PT, MsC Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Study Chair: Clément Médrinal, PT, MsC UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France. Service de réanimation, Groupe Hospitalier du Havre, France
Study Chair: Francis-Edouard Gravier, PT ADIR Association, Bois-Guillaume, France
Study Chair: Tristan Bonnevie, PT, MsC ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
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Responsible Party: ADIR Association
ClinicalTrials.gov Identifier: NCT03312322    
Other Study ID Numbers: LENS-REHAB
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
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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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases