Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Metabolic Exercise Testing (RANNOU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02362685
Recruitment Status : Recruiting
First Posted : February 13, 2015
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
RANNOU, University Hospital, Brest

Tracking Information
First Submitted Date February 4, 2015
First Posted Date February 13, 2015
Last Update Posted Date October 3, 2018
Study Start Date September 2008
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 12, 2015)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02362685 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Metabolic Exercise Testing
Official Title Exercise Testing in Metabolic Myopathies
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood sample Urine sample Muscle tissue DNA
Sampling Method Non-Probability Sample
Study Population Subjects referred to perform a metabolic exercise testing.
Condition
  • Metabolic Myopathies
  • Exercise Test
  • Myalgia
Intervention
  • Device: functional test
    subjects perform a metabolic exercise testing
  • Genetic: matching genotype with phenotype
Study Groups/Cohorts metabolic exercise testing
All the subjects referred to performed a metabolic exercise testing.
Interventions:
  • Device: functional test
  • Genetic: matching genotype with phenotype
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 12, 2015)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Fabrice Rannou, MD, PhD 33(0)298347366 fabrice.rannou@chu-brest.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02362685
Other Study ID Numbers RANNOU
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party RANNOU, University Hospital, Brest
Study Sponsor University Hospital, Brest
Collaborators Not Provided
Investigators
Principal Investigator: Fabrice Rannou, MD, PhD CHRU Brest
PRS Account University Hospital, Brest
Verification Date October 2018