Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

High-frequency transcutaneous electrical nerve stimulation

Low-frequency transcutaneous electrical nerve stimulation

Sham transcutaneous electrical nerve stimulation

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Groupe Hospitalier du Havre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

CWT with high-frequency electrical nerve stimulation

CWT with low-frequency electrical nerve stimulation

CWT with sham electrical nerve stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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).

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).

Blood pressure (mmHg) before and after every CWT.

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).

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).

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).

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).

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).

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).

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).

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).

Intensity of electrical stimulation (mA) reached during every CWT.

Full Information

NCT ID

NCT03312322

First Posted

September 27, 2017

Last Updated

January 8, 2019

Sponsor

ADIR Association

1. Study Identification

Unique Protocol Identification Number

NCT03312322

Brief Title

Effects of Lumbar Transcutaneous Electrical Nerve Stimulation on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease

Acronym

LENS-REHAB

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

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

December 12, 2017 (Actual)

Primary Completion Date

October 26, 2018 (Actual)

Study Completion Date

October 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ADIR Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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

ParticipantOutcomes 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.

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CWT with high-frequency electrical nerve stimulation

Arm Type

Experimental

Arm Description

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.

Arm Title

CWT with low-frequency electrical nerve stimulation

Arm Type

Experimental

Arm Description

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.

Arm Title

CWT with sham electrical nerve stimulation

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

High-frequency transcutaneous electrical nerve stimulation

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Low-frequency transcutaneous electrical nerve stimulation

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Sham transcutaneous electrical nerve stimulation

Intervention Description

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 Measure Information:

Title

Comparison of endurance time (Tlim, in second) during constant workload testing (CWT) under 3 conditions.

Description

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.

Secondary Outcome Measure Information:

Title

Dyspnea during CWT using modified Borg Scale (0-10).

Description

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).

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

Title

Exhaustion during CWT using modified Borg Scale (0-10).

Description

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).

Time Frame

Title

Heart rate (rpm) during CWT.

Description

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).

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

Title

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.

Title

Oxygen saturation (SpO2, %) during CWT.

Description

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).

Time Frame

Title

O2 consumption (VO2, mL/kg/min) during CWT.

Description

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).

Time Frame

Title

Exercise ventilation (VE, L/min) during CWT.

Description

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).

Time Frame

Title

Tidal Volume (Vt, L) during CWT.

Description

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).

Time Frame

Title

Respiratory Rate (RR, rpm) during CWT.

Description

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).

Time Frame

Title

Variation of total hemoglobin (THb) using near infra red spectroscopy.

Description

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).

Time Frame

Title

Variation of total desoxy-hemoglobin (HHb) using near infra red spectroscopy.

Description

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).

Time Frame

Title

Variation of total oxy-hemoglobin (HbO2) using near infra red spectroscopy.

Description

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).

Time Frame

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antoine Cuvelier, Prof, PhD

Organizational 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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jean-François Muir, Prof, PhD

Organizational Affiliation

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Catherine Tardif, MD

Organizational Affiliation

CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Catherine Viacroze, MD

Organizational Affiliation

CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

David Debeaumont, MD

Organizational Affiliation

CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Maxime Patout, MD, MsC

Organizational Affiliation

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Lamia Bouchra, Prof, PhD

Organizational 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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jean Quieffin, MD

Organizational 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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Guillaume Prieur, PT, MsC

Organizational Affiliation

Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Clément Médrinal, PT, MsC

Organizational 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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Francis-Edouard Gravier, PT

Organizational Affiliation

ADIR Association, Bois-Guillaume, France

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Tristan Bonnevie, PT, MsC

Organizational Affiliation

ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France

Official's Role

Study Chair

Facility Information:

Facility Name

Groupe Hospitalier du Havre

City

Le Havre

ZIP/Postal Code

76600

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Effects of Lumbar Transcutaneous Electrical Nerve Stimulation on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease

We'll reach out to this number within 24 hrs