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

NCT03312322 | Completed

• 1 other identifier: LENS-REHAB
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (13)

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

  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

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

  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.

  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.

  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

Study Arms (3)

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.

Other: High-frequency transcutaneous electrical nerve stimulation

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.

Other: Low-frequency transcutaneous electrical nerve stimulation

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.

Other: Sham transcutaneous electrical nerve stimulation

Interventions

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.

CWT with high-frequency electrical nerve stimulation

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.

CWT with low-frequency electrical nerve stimulation

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.

CWT with sham electrical nerve stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years;
• 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.

You may not qualify if:

• Acute exacerbation of chronic obstructive pulmonary disease

Sponsors & Collaborators

• ADIR Association: lead

Study Sites (1)

Groupe Hospitalier du Havre

Le Havre, 76600, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Sham placebo will be used to blind patient. The outcome assessor will be invited to join the room after the experimental condition is installed.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 17, 2017
• Study Start: December 12, 2017
• Primary Completion: October 26, 2018
• Study Completion: October 26, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

FR (1)