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Mitochondrial Dysfunction and Oxidative Stress in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been completed.
Sponsor:
Collaborators:
Centre Hospitalier Régional Universitaire Montpellier
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Groupe Fontalvie
ClinicalTrials.gov Identifier:
NCT01183052
First received: August 16, 2010
Last updated: September 3, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to understand the underlying mechanisms of improved exercise tolerance in COPD patients after training program.


Condition Intervention
COPD Patients
 Other: Training

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Mitochondrial Respiratory Chain and Peripheral Muscle Dysfunction in COPD Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Groupe Fontalvie:

Primary Outcome Measures:
  • Cellular effects of exercise training at the ventilatory threshold intensity [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Training
20 sessions of training
 Other: Training
20 sessions of training
Other Name: CT

Detailed Description:

Training protocol used is based on recommendations (Nici et al., 2006) and was previously used in our group (Varray et al., 1991; Vallet et al., 1997). A minimum of 20 sessions in 4-6 weeks were proposed. The exercise intensity of exercise corresponds to target heart rate at ventilatory threshold measured during incremental exercise test. Training at this intensity allowed us to individualize effort for each patient.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sedentary mild to severe COPD patients

Exclusion Criteria:

  • Neuromuscular disease
  • Chronic heart failure
  • Renal diseases
  • Liver diseases
  • Obesity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183052

Locations
France
Clinique du Souffle La Vallonie
Lodeve, France, 34700
Clinique du Souffle la Solane
Osseja, France, 66340
Sponsors and Collaborators
Groupe Fontalvie
Centre Hospitalier Régional Universitaire Montpellier
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Maurice MH Hayot, MCU-PH Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Groupe Fontalvie
ClinicalTrials.gov Identifier: NCT01183052     History of Changes
Other Study ID Numbers: 2009-A00426-51
Study First Received: August 16, 2010
Last Updated: September 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Fontalvie:
COPD
exercise tolerance
oxidative stress

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

ClinicalTrials.gov processed this record on June 17, 2013