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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.
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) :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CWT with high-frequency electrical nerve stimulation | Experimental | 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. |
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| CWT with low-frequency electrical nerve stimulation | Experimental | 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. |
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| CWT with sham electrical nerve stimulation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-frequency transcutaneous electrical nerve stimulation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of endurance time (Tlim, in second) during constant workload testing (CWT) under 3 conditions. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea during CWT using modified Borg Scale (0-10). | 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). | 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 |
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Inclusion Criteria:
Non-inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier du Havre | Le Havre | 76600 | France |
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Three constant workload testing will be performed on three different days.
Every test will be carried out with a different condition :
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Sham placebo will be used to blind patient. The outcome assessor will be invited to join the room after the experimental condition is installed.
|
| Low-frequency transcutaneous electrical nerve stimulation | Other | 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 | Other | 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. |
|
| Exhaustion during CWT using modified Borg Scale (0-10). | 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). | 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.] |
| Heart rate (rpm) during CWT. | 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). | 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 |
| Blood pressure (mmHg) before and after every CWT. | 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. |
| Oxygen saturation (SpO2, %) during CWT. | 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). | 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 |
| O2 consumption (VO2, mL/kg/min) during CWT. | 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). | 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 |
| Exercise ventilation (VE, L/min) during CWT. | 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). | 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 |
| Tidal Volume (Vt, L) during CWT. | 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). | 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 |
| Respiratory Rate (RR, rpm) during CWT. | 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). | 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 |
| Variation of total hemoglobin (THb) using near infra red spectroscopy. | 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). | 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 |
| Variation of total desoxy-hemoglobin (HHb) using near infra red spectroscopy. | 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). | 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 |
| Variation of total oxy-hemoglobin (HbO2) using near infra red spectroscopy. | 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). | 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 |
| Intensity of electrical stimulation (mA) reached during every CWT. | 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 |
| 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 | Study Chair |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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