We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01679782
First Posted: September 6, 2012
Last Update Posted: March 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
M2H laboratory, Montpellier University
ANRT, National French Agency for Technological Researches
Information provided by (Responsible Party):
5 Santé
  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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 5 Santé
ClinicalTrials.gov Identifier: NCT01679782     History of Changes
Other Study ID Numbers: FVIE_FA1
First Submitted: September 3, 2012
First Posted: September 6, 2012
Last Update Posted: March 10, 2015
Last Verified: March 2015

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

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