Clinical trial NCT03312322: Effects of Lumbar Transcutaneous Electrical Nerve Stimulation on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease
Official title: Effects of Lumbar Transcutaneous Electrical Nerve Stimulation on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease : A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: ADIR Association
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Comparison of endurance time (Tlim, in second) during constant workload testing (CWT) under 3 conditions.
timeFrame: 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.
Secondary outcomes:
measure: Dyspnea during CWT using modified Borg Scale (0-10).
timeFrame: 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
measure: Exhaustion during CWT using modified Borg Scale (0-10).
timeFrame: 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.]
measure: Heart rate (rpm) during CWT.
timeFrame: 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
measure: Blood pressure (mmHg) before and after every CWT.
timeFrame: 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.
measure: Oxygen saturation (SpO2, %) during CWT.
timeFrame: 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
measure: O2 consumption (VO2, mL/kg/min) during CWT.
timeFrame: 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
measure: Exercise ventilation (VE, L/min) during CWT.
timeFrame: 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
measure: Tidal Volume (Vt, L) during CWT.
timeFrame: 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
measure: Respiratory Rate (RR, rpm) during CWT.
timeFrame: 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
measure: Variation of total hemoglobin (THb) using near infra red spectroscopy.
timeFrame: 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
measure: Variation of total desoxy-hemoglobin (HHb) using near infra red spectroscopy.
timeFrame: 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
measure: Variation of total oxy-hemoglobin (HbO2) using near infra red spectroscopy.
timeFrame: 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
measure: Intensity of electrical stimulation (mA) reached during every CWT.
timeFrame: 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
Other outcomes:
Locations:
city: Le Havre
country: France
facility: Groupe Hospitalier du Havre
Study officials:
affiliation: 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
name: Antoine Cuvelier, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 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
name: Jean-François Muir, Prof, PhD
role: STUDY_CHAIR
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
name: Catherine Tardif, MD
role: STUDY_CHAIR
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
name: Catherine Viacroze, MD
role: STUDY_CHAIR
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
name: David Debeaumont, MD
role: STUDY_CHAIR
affiliation: 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
name: Maxime Patout, MD, MsC
role: STUDY_CHAIR
affiliation: 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
name: Lamia Bouchra, Prof, PhD
role: STUDY_CHAIR
affiliation: 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
name: Jean Quieffin, MD
role: STUDY_CHAIR
affiliation: Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
name: Guillaume Prieur, PT, MsC
role: STUDY_CHAIR
affiliation: 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
name: Clément Médrinal, PT, MsC
role: STUDY_CHAIR
affiliation: ADIR Association, Bois-Guillaume, France
name: Francis-Edouard Gravier, PT
role: STUDY_CHAIR
affiliation: ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
name: Tristan Bonnevie, PT, MsC
role: STUDY_CHAIR
References: