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Muscle Training Induced Angiogenesis in COPD (COPDµvasc)

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ClinicalTrials.gov Identifier: NCT02040363
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : November 1, 2016
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Université Montpellier
5 Santé
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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 exercise training induce a physiological angiogenesis, we have recently observed that there was a blunted muscle angiogenesis after training in COPD patients. This could be the consequence a an inadequate training duration or intensity. Aim of the study: Compare the muscle micro-vascular response to training (capillary-to-fiber ratio) 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).

Condition or disease Intervention/treatment Phase
Peripheral Muscle Dysfunction COPD Procedure: Muscular biopsy Other: 5-10 weeks sport training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Impact of Different Training Modalities on Skeletal Muscle Angiogenic Response in COPD Patients - COPDµvasc Study
Study Start Date : January 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Active Comparator: COPD Patients ~90% VO2max
COPD Patients ~90% VO2max
Procedure: Muscular biopsy
Active Comparator: COPD patients ~60-65% VO2max
COPD patients ~60-65% VO2max
Procedure: Muscular biopsy
Placebo Comparator: healthy volunteers
healthy volunteers
Procedure: Muscular biopsy
Other: 5-10 weeks sport training



Primary Outcome Measures :
  1. Capillary-o-fiber ratio assessed by immunochemistry on a muscle biopsy of the vastus lateralis of the quadriceps [ Time Frame: 5 weeks ]
  2. Capillary-o-fiber ratio assessed by immunochemistry on a muscle biopsy of the vastus lateralis of the quadriceps [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. quadriceps endurance [ Time Frame: 5 weeks ]
  2. mitochondrial density [ Time Frame: 5 weeks ]
  3. muscle citrate synthase activity [ Time Frame: 5 weeks ]
  4. quadriceps endurance [ Time Frame: 10 weeks ]
  5. mitochondrial density [ Time Frame: 10 weeks ]
  6. muscle citrate synthase activity [ Time Frame: 10 weeks ]


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Ages Eligible for Study:   40 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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, ...

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040363


Locations
France
Department of clinical Physiology - University Hospital
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Institut National de la Santé Et de la Recherche Médicale, France
Université Montpellier
5 Santé
Investigators
Principal Investigator: Farés Gouzi University Hospital

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02040363     History of Changes
Other Study ID Numbers: 9224
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by University Hospital, Montpellier:
COPD
skeletal muscle
angiogenesis
exercise training
intensity