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

This study has been completed.
Sponsor:
Collaborators:
M2H laboratory, Montpellier University
ANRT, National French Agency for Technological Researches
Information provided by (Responsible Party):
5 Santé
ClinicalTrials.gov Identifier:
NCT01679782
First received: September 3, 2012
Last updated: March 9, 2015
Last verified: March 2015
  Purpose

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.


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
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.

Further study details as provided by 5 Santé:

Primary Outcome Measures:
  • Level of voluntary activation [ Time Frame: 2h ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

whole blood


Enrollment: 137
Study Start Date: July 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Epilepsy, pace-maker, nervous disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679782

Locations
France
Clinique du Souffle La Vallonie
Lodève, France, 34700
Sponsors and Collaborators
5 Santé
M2H laboratory, Montpellier University
ANRT, National French Agency for Technological Researches
Investigators
Study Director: Alain AV Varray, Pr M2H laboratory, Montpellier
  More Information

No publications provided

Responsible Party: 5 Santé
ClinicalTrials.gov Identifier: NCT01679782     History of Changes
Other Study ID Numbers: FVIE_FA1
Study First Received: September 3, 2012
Last Updated: March 9, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by 5 Santé:
COPD, nervous system, peripheral muscle dysfunction

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 01, 2015