Effects of Lumbar Transcutaneous Electrical Nerve Stimulation on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease
NCT ID: NCT03312322
Last Updated: 2019-01-09
Study Results
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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COMPLETED
NA
10 participants
INTERVENTIONAL
2017-12-12
2018-10-26
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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.
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Chronic obstructive pulmonary disease Gold III-IV;
* Eligible for pulmonary rehabilitation;
* Never used electrical stimulation.
* 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
18 Years
ALL
No
Sponsors
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ADIR Association
OTHER
Responsible Party
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Principal Investigators
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Antoine Cuvelier, Prof, PhD
Role: PRINCIPAL_INVESTIGATOR
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
Jean-François Muir, Prof, PhD
Role: STUDY_CHAIR
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
Catherine Tardif, MD
Role: STUDY_CHAIR
CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Catherine Viacroze, MD
Role: STUDY_CHAIR
CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
David Debeaumont, MD
Role: STUDY_CHAIR
CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Maxime Patout, MD, MsC
Role: STUDY_CHAIR
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
Lamia Bouchra, Prof, PhD
Role: STUDY_CHAIR
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
Jean Quieffin, MD
Role: STUDY_CHAIR
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
Guillaume Prieur, PT, MsC
Role: STUDY_CHAIR
Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Clément Médrinal, PT, MsC
Role: STUDY_CHAIR
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
Francis-Edouard Gravier, PT
Role: STUDY_CHAIR
ADIR Association, Bois-Guillaume, France
Tristan Bonnevie, PT, MsC
Role: STUDY_CHAIR
ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
Locations
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Groupe Hospitalier du Havre
Le Havre, , France
Countries
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Other Identifiers
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LENS-REHAB
Identifier Type: -
Identifier Source: org_study_id
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