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NCT01183052 Clinical Trial

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

COPD Patients Clinical Trial

Official title:
Mitochondrial Respiratory Chain and Peripheral Muscle Dysfunction in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01183052
Other study ID # 2009-A00426-51
Secondary ID
Status Completed
Phase N/A
First received August 16, 2010
Last updated September 3, 2012
Start date June 2009
Est. completion date December 2010

Study information
Verified date September 2012
Source 5 Santé
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 75 Years
Eligibility Inclusion Criteria:

- Sedentary mild to severe COPD patients

Exclusion Criteria:

- Neuromuscular disease

- Chronic heart failure

- Renal diseases

- Liver diseases

- Obesity

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Other:
• Training
20 sessions of training

Locations
Country Name City State
France Clinique du Souffle La Vallonie Lodeve
France Clinique du Souffle la Solane Osseja

Sponsors (3)
Lead Sponsor Collaborator
5 Santé Centre Hospitalier Régional Universitaire Montpellier, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cellular effects of exercise training at the ventilatory threshold intensity 6 to 8 weeks Yes
See also
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Recruiting NCT03774238 - Determinants of the Vascular Response to Training in Chronic Obstructive Pulmonary Disease (COPD) Patients N/A
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