Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Groupe Fontalvie.
Recruitment status was  Recruiting
M2H laboratory, Montpellier University
ANRT, National French Agency for Technological Researches
Information provided by (Responsible Party):
Groupe Fontalvie Identifier:
First received: September 3, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted

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.

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 Groupe Fontalvie:

Biospecimen Retention:   Samples Without DNA

whole blood

Estimated Enrollment: 45
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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.


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


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 identifier: NCT01679782

Contact: Francois FA Alexandre, PhD student 0666678916 ext 0033
Contact: Alain AV Varray, Pr 0411759070 ext 0033

Clinique du Souffle La Vallonie Recruiting
Lodève, France, 34700
Contact: Francois FA Alexandre, PhD student    0666678916 ext 0033   
Sponsors and Collaborators
Groupe Fontalvie
M2H laboratory, Montpellier University
ANRT, National French Agency for Technological Researches
Study Director: Alain AV Varray, Pr M2H laboratory, Montpellier
  More Information

No publications provided

Responsible Party: Groupe Fontalvie Identifier: NCT01679782     History of Changes
Other Study ID Numbers: FVIE_FA1
Study First Received: September 3, 2012
Last Updated: September 3, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Groupe Fontalvie:
COPD, nervous system, peripheral muscle dysfunction

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases processed this record on February 25, 2015