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Metabolic Exercise Testing (RANNOU)

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ClinicalTrials.gov Identifier: NCT02362685
Recruitment Status : Recruiting
First Posted : February 13, 2015
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
RANNOU, University Hospital, Brest

Brief Summary:
Exertional symptoms are the hallmarks of metabolic myopathies, supporting the concept of using functional tests when this diagnosis is suspected. Exercise increases the concentration of muscle metabolites in the venous blood supply (e.g. lactate, pyruvate, and ammonia) especially during recovery. The purpose of this study is to compare the results of exercise testing with to the data from muscle biopsy or genetic analysis.

Condition or disease Intervention/treatment
Metabolic Myopathies Exercise Test Myalgia Device: functional test Genetic: matching genotype with phenotype

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exercise Testing in Metabolic Myopathies
Study Start Date : September 2008
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
metabolic exercise testing
All the subjects referred to performed a metabolic exercise testing.
Device: functional test
subjects perform a metabolic exercise testing
Genetic: matching genotype with phenotype



Primary Outcome Measures :
  1. Whole-body dynamic exercise [ Time Frame: Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed ]
    The relation between Cardiopulmonary exercise test variables and the results of muscle biopsy or genetic analysis will be evaluated.

  2. Grip-test [ Time Frame: Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed ]
    The relation between Grip-test variables and the results of muscle biopsy or genetic analysis will be evaluated.

  3. Blood tests [ Time Frame: Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed ]
    The results of blood analysis from samples performed before, during, and after exercise will be compared to the results of muscle biopsy or genetic analysis.


Biospecimen Retention:   Samples With DNA
Blood sample Urine sample Muscle tissue DNA


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects referred to perform a metabolic exercise testing.
Criteria

Inclusion Criteria:

  • Referred to the Physiology Department of Brest Hospital for a metabolic exercise test
  • Ability to provide informed consent

Exclusion Criteria:

  • Contraindication(s) to perform cardiopulmonary exercise testing (ATS/ACCP statement on cardiopulmonary exercise testing, Am J respi Care Med 167: 211-77, 2003)
  • Pregnancy or unknown pregnancy status.

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): NCT02362685


Contacts
Contact: Fabrice Rannou, MD, PhD 33(0)298347366 fabrice.rannou@chu-brest.fr

Locations
France
Centre Hospitalier Régional Universitaire Recruiting
Brest, France, 29609
Contact: Fabrice Rannou, MD, PhD    33(0)298347366    fabrice.rannnou@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Fabrice Rannou, MD, PhD CHRU Brest

Responsible Party: RANNOU, MD, PhD, University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02362685     History of Changes
Other Study ID Numbers: RANNOU
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by RANNOU, University Hospital, Brest:
Metabolic myopathies
Exercise testing
Blood sample
Muscle biopsy
Genetic analysis
Cycloergometer
Grip-test
Exercise physiology
Muscle physiology

Additional relevant MeSH terms:
Muscular Diseases
Myalgia
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Signs and Symptoms