Development and Validation Phase of Diffusion Tensor Imaging and Arterial Spin Labelling at 3 Tesla Using a Long-term Effort Model Applicable to Skeletal Muscle Characterization.
1 other identifier
interventional
25
1 country
1
Brief Summary
The aim of this study is to demonstrate and quantify the micro architecture and micro vascular changes within skeletal muscles after marathon using 3T MRI (diffusion tensor and arterial spin labeling). Apparent diffusion coefficient, fractional anisotropy and flow parameters will be registered before and after the long-distance run on the lower leg. Axial T1 and axial SPAIR sequences will also be applied at the same time.Stress ox and inflammatory markers will be collected in blood and urine samples and compare with both MRI and Near-infrared spectroscopy (NIRS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2013
1 active site
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
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 17, 2013
CompletedFirst Posted
Study publicly available on registry
December 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedJune 8, 2017
December 1, 2013
1.5 years
December 17, 2013
June 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fractional Anisotropy (FA) measure
The measures will be made from sequences echoplanar (EAR), and will be extracted by post-treatment software Siemens untitled " Syngo" and "FSL", allowing a distortions correction.
at 4 days
Secondary Outcomes (1)
Apparent Diffusion Coefficient (ADC) value
at 4 days
Study Arms (1)
Marathoners
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Realizing between 2:10 and 4:30 in the marathon.
You may not qualify if:
- Smoker
- Subject with medical treatment or with a treatment interrupted for less than 30 days.
- Subject with a osteo-articular, cardiovascular, infectious, lung pathology and/or a metabolic chronic pathology.
- MRI Contraindication : Claustrophobic subject ; subject with a intra-cranial vascular clip, with a pacemaker, with a neurostimulator or a cochlear implant ; subject with intraocular metallic foreign bodies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Montpellier
Montpellier, 34295, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sébastien BOMMART
University Hospital, Montpellier
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2013
First Posted
December 23, 2013
Study Start
March 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
June 8, 2017
Record last verified: 2013-12