Involvement of Nervous System in Muscle Weakness in COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

— DesCoM-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679782
• Other study ID #: FVIE_FA1
• Status: Completed
• Phase: N/A
• First received: September 3, 2012
• Last updated: March 9, 2015
• Start date: July 2012
• Est. completion date: April 2014

Study information

• Verified date: March 2015
• Source: 5 Santé
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• COPD Patients at stage 2 and 3

• Healthy sedentary subjects

Exclusion Criteria:

• Epilepsy, pace-maker, nervous disorders

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
France	Clinique du Souffle La Vallonie	Lodève

Sponsors (3)

Lead Sponsor	Collaborator
5 Santé	ANRT, National French Agency for Technological Researches, M2H laboratory, Montpellier University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of voluntary activation		2h	Yes