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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

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, ...

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Muscular biopsy

Other:
5-10 weeks sport training


Locations

Country Name City State
France Department of clinical Physiology - University Hospital Montpellier

Sponsors (4)

Lead Sponsor Collaborator
University Hospital, Montpellier 5 Santé, Institut National de la Santé Et de la Recherche Médicale, France, Université Montpellier

Country where clinical trial is conducted

France, 

Outcome

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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