- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02362685
Metabolic Exercise Testing (RANNOU)
January 21, 2020 updated by: RANNOU, University Hospital, Brest
Exercise Testing in Metabolic Myopathies
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fabrice Rannou, MD, PhD
- Phone Number: 33(0)298347366
- Email: fabrice.rannou@chu-brest.fr
Study Contact Backup
- Name: Fabrice Rannou, MD, PhD
- Phone Number: 33(0)298347366
- Email: fabrice.rannou@univ-brest.fr
Study Locations
-
-
-
Brest, France, 29609
- Recruiting
- Centre hospitalier régional universitaire
-
Contact:
- Fabrice Rannou, MD, PhD
- Phone Number: 33(0)298347366
- Email: fabrice.rannnou@univ-brest.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects referred to perform a metabolic exercise testing.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
metabolic exercise testing
All the subjects referred to performed a metabolic exercise testing.
|
subjects perform a metabolic exercise testing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed
|
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.
|
Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed
|
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.
|
Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fabrice Rannou, MD, PhD, Chru Brest
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Anticipated)
December 1, 2027
Study Completion (Anticipated)
December 1, 2027
Study Registration Dates
First Submitted
February 4, 2015
First Submitted That Met QC Criteria
February 12, 2015
First Posted (Estimate)
February 13, 2015
Study Record Updates
Last Update Posted (Actual)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 21, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RANNOU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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