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

September 3, 2012
March 9, 2015
July 2012
April 2014   (final data collection date for primary outcome measure)
Level of voluntary activation [ Time Frame: 2h ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT01679782 on ClinicalTrials.gov Archive Site
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Involvement of Nervous System in Muscle Weakness in COPD Patients
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.
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.
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Description:
whole blood
Non-Probability Sample
Two groups of COPD patients and one group with healthy sedentary subjects
Chronic Obstructive Pulmonary Disease
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  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
137
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Epilepsy, pace-maker, nervous disorders
Both
40 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01679782
FVIE_FA1
Yes
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5 Santé
5 Santé
  • M2H laboratory, Montpellier University
  • ANRT, National French Agency for Technological Researches
Study Director: Alain AV Varray, Pr M2H laboratory, Montpellier
5 Santé
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP