- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02040363
Muscle Training Induced Angiogenesis in COPD (COPDµvasc)
Impact of Exercise Training on Skeletal Muscle Capillary Maturation During Angiogenesis in COPD Patients
COPD patients experiment a peripheral muscle dysfunction which impact their exercise tolerance and health-related quality of life. The capillary to fiber interface is reduced and impact the exercise capacity of the patients. While the muscle capillary creation in response to exercise training is blunted in COPD patients, the maturation of the neo-capillaries could also be blunted and contribute to the impaired aniogionenesis in patients. Because the capillary maturation is a sensitive and dynamic process, only different modalities of exercise training and multiple time-points of measures would allow to capture this microvascular adaptation.
Aim of the study : Compare the muscle capillary maturation in response to training at 5 and 10 weeks, in sedentary healthy subject trained at the intensity of the ventilatory threshold (60-65% of VO2max), versus :- COPD patients trained at a similar intensity (60-65% of VO2max)- COPD patients trained at a similar absolute intensity (90% of VO2max).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
-
Montpellier, France, 34295
- Department of clinical Physiology - University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- COPD patients :
- FEV1<80%pred.
- non exacerbation during the past 4 weeks
- no oxygen therapy, -
Healthy subjects:
- <150min/week of moderate-to-vigorous physical activity,
- Voorrips score <9
Exclusion Criteria:
- Unstable comorbidity
- Long term oxygen therapy or ventilation
- Rehabilitation program during the past 12 months
- nutritional supplementation during the past 4 weeks
- allopurinol or N-acetylcystein during the past 4 weeks
- long corticosteroid treatment during the past 6 months
- hyperreactivity to xylocain
- anticoagulant or platelet aggregation inhibitors treatment
- participation to an other research study-pregnancy or impossibility to provide informed consent, ...
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: COPD Patients ~90% VO2max
|
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Active Comparator: COPD patients ~60-65% VO2max
|
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Placebo Comparator: healthy volunteers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Capillary-o-fiber ratio assessed by immunochemistry on a muscle biopsy of the vastus lateralis of the quadriceps
Time Frame: 5 weeks
|
5 weeks
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Capillary-o-fiber ratio assessed by immunochemistry on a muscle biopsy of the vastus lateralis of the quadriceps
Time Frame: 10 weeks
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
quadriceps endurance
Time Frame: 5 weeks
|
5 weeks
|
quadriceps endurance
Time Frame: 10 weeks
|
10 weeks
|
Pericyte coverage of skeletal muscles capillaries assessed by immunostaining of a muscle biopsy of the vastus lateralis of the quadriceps
Time Frame: 5 weeks
|
5 weeks
|
Pericyte coverage of skeletal muscles capillaries assessed by immunostaining of a muscle biopsy of the vastus lateralis of the quadriceps
Time Frame: 10 weeks
|
10 weeks
|
Effect of the serum of COPD patients and SHS on pericyte morphology and in vitro
Time Frame: 10 weeks
|
10 weeks
|
Effect of the serum of COPD patients and SHS on pericyte/endothelial cells interactions in vitro
Time Frame: 10 weeks
|
10 weeks
|
Effect of the serum of COPD patients and SHS on pericyte/endothelial cells interactions in vivo
Time Frame: 10 weeks
|
10 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Farés Gouzi, University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 9224
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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