NCT02040363

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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

2.2 years

First QC Date

January 10, 2014

Last Update Submit

January 10, 2020

Conditions

Peripheral Muscle DysfunctionCOPD

Keywords

COPDskeletal muscleangiogenesisexercise trainingintensity

Outcome Measures

Primary Outcomes (2)

  • Capillary-o-fiber ratio assessed by immunochemistry on a muscle biopsy of the vastus lateralis of the quadriceps

    5 weeks

  • Capillary-o-fiber ratio assessed by immunochemistry on a muscle biopsy of the vastus lateralis of the quadriceps

    10 weeks

Secondary Outcomes (7)

  • quadriceps endurance

    5 weeks

  • quadriceps endurance

    10 weeks

  • Pericyte coverage of skeletal muscles capillaries assessed by immunostaining of a muscle biopsy of the vastus lateralis of the quadriceps

    5 weeks

  • Pericyte coverage of skeletal muscles capillaries assessed by immunostaining of a muscle biopsy of the vastus lateralis of the quadriceps

    10 weeks

  • Effect of the serum of COPD patients and SHS on pericyte morphology and in vitro

    10 weeks

  • +2 more secondary outcomes

Study Arms (3)

COPD Patients ~90% VO2max

ACTIVE COMPARATOR

COPD Patients \~90% VO2max

Procedure: Muscular biopsy

COPD patients ~60-65% VO2max

ACTIVE COMPARATOR

COPD patients \~60-65% VO2max

Procedure: Muscular biopsy

healthy volunteers

PLACEBO COMPARATOR

healthy volunteers

Procedure: Muscular biopsyOther: 5-10 weeks sport training

Interventions

Muscular biopsyPROCEDURE
COPD Patients ~90% VO2maxCOPD patients ~60-65% VO2maxhealthy volunteers
5-10 weeks sport trainingOTHER
healthy volunteers

Eligibility Criteria

Age40 Years - 78 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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, ...

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of clinical Physiology - University Hospital

Montpellier, 34295, France

Location

Related Publications (1)

  • Souweine 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.

    PMID: 34750160DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Farés Gouzi

    University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 20, 2014

Study Start

January 1, 2014

Primary Completion

April 1, 2016

Study Completion

August 1, 2016

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations

FR(1)