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NCT02362685 Clinical Trial

Metabolic Exercise Testing

Myalgia Clinical Trial

— RANNOU  

Official title:
Exercise Testing in Metabolic Myopathies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02362685
Other study ID # RANNOU
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2008
Est. completion date December 2027

Study information
Verified date January 2020
Source University Hospital, Brest
Contact Fabrice Rannou, MD, PhD
Phone 33(0)298347366
Email fabrice.rannou@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• functional test
subjects perform a metabolic exercise testing
Genetic:
• matching genotype with phenotype

Locations
Country Name City State
France Centre Hospitalier Régional Universitaire Brest

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Whole-body dynamic exercise The relation between Cardiopulmonary exercise test variables and the results of muscle biopsy or genetic analysis will be evaluated. Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed
Primary Grip-test The relation between Grip-test variables and the results of muscle biopsy or genetic analysis will be evaluated. Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed
Primary Blood tests 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. Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed
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