Involvement of Nervous System in Muscle Weakness in COPD Patients (DesCoM-1)

Phase 1 Impact of Nocturnal Desaturations on Central Motor Drive in COPD Patients: A New Insight on the Systemic Effects of the Disease.

The purpose of this study is to determine whether nervous system alterations and motor drive failure can contribute to muscle weakness in COPD during voluntary movement. If necessary, we will look after the role of nocturnal hypoxia in these alterations.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease

Detailed Description

COPD is a common disease that induces many systemic repercussions. Among these, peripheral muscle dysfunction is particularly deleterious because it leads to the decreases of the level of activity and the quality of life for patients. Movement involves activation of many structures, from the instructor, i.e. the brain, to the effector, i.e. the muscle. Netherless, the studies which have described peripheral muscle dysfunction have been focused on the muscle, so they have proposed a reducing vision of the phenomenon. Other studies have reported cerebral alterations in COPD, like cognitive disturbance, increase of the neuronal conduction time, and decrease of the white matter density, and were associated with chronic hypoxemia. Such alterations are consistent with the existence of a decrease of the central motor drive during voluntary movement in COPD patients. Therefore the study will aim to determine precisely which mechanisms are involved in peripheral muscle dysfunction in copd.

• Study Type: Observational
• Enrollment (Actual): 137

Contacts and Locations

Study Locations

• France
  • Lodève, France, 34700
    • Clinique du Souffle La Vallonie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Two groups of COPD patients and one group with healthy sedentary subjects

Description

Inclusion Criteria:

• COPD Patients at stage 2 and 3
• Healthy sedentary subjects

Exclusion Criteria:

• Epilepsy, pace-maker, nervous disorders

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
COPD nocturnal desaturator; COPD patients who spend 30% of the nigth with a SaO2 < 90%.
COPD no nocturnal desaturator; COPD patients who spend less than 30% of the night with a SaO2 < 90%
control group; healthy sedentary subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Level of voluntary activation	2h

Collaborators and Investigators

• Sponsor: 5 Santé
• Collaborators: M2H laboratory, Montpellier University; ANRT, National French Agency for Technological Researches
• Investigators: Study Director: Alain AV Varray, Pr, M2H laboratory, Montpellier

Publications and helpful links

General Publications

• Alexandre F, Heraud N, Sanchez AM, Tremey E, Oliver N, Guerin P, Varray A. Brain Damage and Motor Cortex Impairment in Chronic Obstructive Pulmonary Disease: Implication of Nonrapid Eye Movement Sleep Desaturation. Sleep. 2016 Feb 1;39(2):327-35. doi: 10.5665/sleep.5438.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: September 3, 2012
• First Submitted That Met QC Criteria: September 3, 2012
• First Posted (Estimate): September 6, 2012

Study Record Updates

• Last Update Posted (Estimate): March 10, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: COPD, nervous system, peripheral muscle dysfunction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: FVIE_FA1