COPD Clinical Trial
— COPDµvascOfficial title:
Impact of Exercise Training on Skeletal Muscle Capillary Maturation During Angiogenesis in COPD Patients
| NCT number | NCT02040363 |
| Other study ID # | 9224 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2014 |
| Est. completion date | August 2016 |
| Verified date | January 2020 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | August 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 40 Years to 78 Years |
| Eligibility |
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, ... |
| Country | Name | City | State |
|---|---|---|---|
| France | Department of clinical Physiology - University Hospital | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier | 5 Santé, Institut National de la Santé Et de la Recherche Médicale, France, Université Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Capillary-o-fiber ratio assessed by immunochemistry on a muscle biopsy of the vastus lateralis of the quadriceps | 5 weeks | ||
| Primary | Capillary-o-fiber ratio assessed by immunochemistry on a muscle biopsy of the vastus lateralis of the quadriceps | 10 weeks | ||
| Secondary | quadriceps endurance | 5 weeks | ||
| Secondary | quadriceps endurance | 10 weeks | ||
| Secondary | Pericyte coverage of skeletal muscles capillaries assessed by immunostaining of a muscle biopsy of the vastus lateralis of the quadriceps | 5 weeks | ||
| Secondary | Pericyte coverage of skeletal muscles capillaries assessed by immunostaining of a muscle biopsy of the vastus lateralis of the quadriceps | 10 weeks | ||
| Secondary | Effect of the serum of COPD patients and SHS on pericyte morphology and in vitro | 10 weeks | ||
| Secondary | Effect of the serum of COPD patients and SHS on pericyte/endothelial cells interactions in vitro | 10 weeks | ||
| Secondary | Effect of the serum of COPD patients and SHS on pericyte/endothelial cells interactions in vivo | 10 weeks |
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