- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01183052
Mitochondrial Dysfunction and Oxidative Stress in Chronic Obstructive Pulmonary Disease (COPD) Patients
September 3, 2012 updated by: 5 Santé
Mitochondrial Respiratory Chain and Peripheral Muscle Dysfunction in COPD Patients
The purpose of this study is to understand the underlying mechanisms of improved exercise tolerance in COPD patients after training program.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lodeve, France, 34700
- Clinique du Souffle La Vallonie
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Osseja, France, 66340
- Clinique du Souffle la Solane
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Sedentary mild to severe COPD patients
Exclusion Criteria:
- Neuromuscular disease
- Chronic heart failure
- Renal diseases
- Liver diseases
- Obesity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Training
20 sessions of training
|
20 sessions of training
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cellular effects of exercise training at the ventilatory threshold intensity
Time Frame: 6 to 8 weeks
|
6 to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Maurice MH Hayot, MCU-PH, Institut National de la Santé Et de la Recherche Médicale, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
August 16, 2010
First Submitted That Met QC Criteria
August 16, 2010
First Posted (Estimate)
August 17, 2010
Study Record Updates
Last Update Posted (Estimate)
September 5, 2012
Last Update Submitted That Met QC Criteria
September 3, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2009-A00426-51
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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