Peripheral Muscle DysfunctionCOPDµvascNCT02040363
Muscle Training Induced Angiogenesis in COPD
A study testing Muscular biopsy and 5-10 weeks sport training in people with Peripheral Muscle Dysfunction and COPD, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 40 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Muscle Dysfunction, COPD
- What is being tested?
- Muscular biopsy and 5-10 weeks sport training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- hyperreactivity to xylocain
- anticoagulant or platelet aggregation inhibitors treatment
- participation to an other research study-pregnancy or impossibility to provide informed consent, ...
Trial locations and contacts
1 site in 1 country.
France1 site
Department of clinical Physiology - University Hospital
Montpellier, 34295
About this study
Official title: 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).
- Conditions
- Peripheral Muscle Dysfunction, COPD
- Being tested
- Muscular biopsy, 5-10 weeks sport training
- Keywords
- COPD, skeletal muscle, angiogenesis, exercise training, intensity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscular biopsyProcedure or surgery
5-10 weeks sport trainingOther
| Study group | Role | What they receive |
|---|---|---|
| COPD Patients ~90% VO2max | Active comparator | COPD Patients ~90% VO2max Receives: Procedure: Muscular biopsy |
| COPD patients ~60-65% VO2max | Active comparator | COPD patients ~60-65% VO2max Receives: Procedure: Muscular biopsy |
| healthy volunteers | Placebo comparator | healthy volunteers Receives: Procedure: Muscular biopsy; Other: 5-10 weeks sport training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary-o-fiber ratio assessed by immunochemistry on a muscle biopsy of the vastus lateralis of the quadriceps
Measured: 5 weeks
Capillary-o-fiber ratio assessed by immunochemistry on a muscle biopsy of the vastus lateralis of the quadriceps
Measured: 10 weeks
Secondary outcomes (7)
quadriceps endurance
Measured: 5 weeks
quadriceps endurance
Measured: 10 weeks
Pericyte coverage of skeletal muscles capillaries assessed by immunostaining of a muscle biopsy of the vastus lateralis of the quadriceps
Measured: 5 weeks
Pericyte coverage of skeletal muscles capillaries assessed by immunostaining of a muscle biopsy of the vastus lateralis of the quadriceps
Measured: 10 weeks
Effect of the serum of COPD patients and SHS on pericyte morphology and in vitro
Measured: 10 weeks
Effect of the serum of COPD patients and SHS on pericyte/endothelial cells interactions in vitro
Measured: 10 weeks
Effect of the serum of COPD patients and SHS on pericyte/endothelial cells interactions in vivo
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Muscle DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Université Montpellier, 5 Santé
- Responsible party
- Sponsor
- Investigators
- Farés Gouzi, Principal investigator, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040363
- Sponsor's protocol ID
- 9224
- Acronym
- COPDµvasc
- Status last verified
- Jun 2026
- First submitted
- 10 Jan 2014
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Gouzi F, Philippe A, Blervaque L, Gunther S, Virsolvy A, Gruest M, Cazorla O, Rossi E, Smadja DM. Plasma ratio of angiopoietin-2 to angiopoietin-1 is a biomarker of vascular impairment in chronic obstructive pulmonary disease patients. Angiogenesis. 2022 Aug;25(3):275-277. doi: 10.1007/s10456-021-09826-1. Epub 2022 Jan 11.
PubMed 35013842Souweine JS, Gouzi F, Badia E, Pomies P, Garrigue V, Morena M, Hayot M, Mercier J, Ayoub B, Quintrec ML, Raynaud F, Cristol JP. Skeletal Muscle Phenotype in Patients Undergoing Long-Term Hemodialysis Awaiting Kidney Transplantation. Clin J Am Soc Nephrol. 2021 Nov;16(11):1676-1685. doi: 10.2215/CJN.02390221.
PubMed 34750160
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise Training on Skeletal Muscle Capillary Maturation During Angiogenesis in COPD Patients
- ClinicalTrials.gov ID
- NCT02040363
- Acronym / sponsor ID
- COPDµvasc / 9224
- Conditions
- Peripheral Muscle Dysfunction, COPD
- Keywords
- COPD, skeletal muscle, angiogenesis, exercise training, intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Université Montpellier, 5 Santé
- Study start
- Jan 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD Patients ~90% VO2max | Active comparator | Procedure: Muscular biopsyCOPD Patients ~90% VO2max |
| COPD patients ~60-65% VO2max | Active comparator | Procedure: Muscular biopsyCOPD patients ~60-65% VO2max |
| healthy volunteers | Placebo comparator | Procedure: Muscular biopsy, Other: 5-10 weeks sport traininghealthy volunteers |
Who may qualify
- Ages
- 40 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- COPD patients :
- FEV1<80%pred.
- non exacerbation during the past 4 weeks
- no oxygen therapy, -
- <150min/week of moderate-to-vigorous physical activity,
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscular biopsy | Procedure or surgery | COPD Patients ~90% VO2max, COPD patients ~60-65% VO2max, healthy volunteers |
| 5-10 weeks sport training | Other | healthy volunteers |
Primary outcome
Capillary-o-fiber ratio assessed by immunochemistry on a muscle biopsy of the vastus lateralis of the quadriceps
Time frame: 5 weeks
Capillary-o-fiber ratio assessed by immunochemistry on a muscle biopsy of the vastus lateralis of the quadriceps
Time frame: 10 weeks
7 secondary outcomes
quadriceps endurance
Time frame: 5 weeks
quadriceps endurance
Time frame: 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
Pericyte coverage of skeletal muscles capillaries assessed by immunostaining of a muscle biopsy of the vastus lateralis of the quadriceps
Time frame: 10 weeks
Effect of the serum of COPD patients and SHS on pericyte morphology and in vitro
Time frame: 10 weeks
Effect of the serum of COPD patients and SHS on pericyte/endothelial cells interactions in vitro
Time frame: 10 weeks
Effect of the serum of COPD patients and SHS on pericyte/endothelial cells interactions in vivo
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publication: PubMed 35013842Gouzi F, Philippe A, Blervaque L, Gunther S, Virsolvy A, Gruest M, Cazorla O, Rossi E, Smadja DM. Plasma ratio of angiopoietin-2 to angiopoietin-1 is a biomarker of vascular impairment in chronic obstructive pulmonary disease patients. Angiogenesis. 2022 Aug;25(3):275-277. doi: 10.1007/s10456-021-09826-1. Epub 2022 Jan 11.
- Derived from this study: PubMed 34750160Souweine JS, Gouzi F, Badia E, Pomies P, Garrigue V, Morena M, Hayot M, Mercier J, Ayoub B, Quintrec ML, Raynaud F, Cristol JP. Skeletal Muscle Phenotype in Patients Undergoing Long-Term Hemodialysis Awaiting Kidney Transplantation. Clin J Am Soc Nephrol. 2021 Nov;16(11):1676-1685. doi: 10.2215/CJN.02390221.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farés Gouzi principal investigator
University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscular biopsy and 5-10 weeks sport training in people with Peripheral Muscle Dysfunction and COPD, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary-o-fiber ratio assessed by immunochemistry on a muscle biopsy of the vastus lateralis of the quadriceps (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02040363, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.