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.

Not Applicable

Completed

• Conditions: Marathoners
• Interventions: Device: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT02018718
• Lead Sponsor: University Hospital, Montpellier

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Status Verified: 2013-12
• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-23
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

• Realizing between 2:10 and 4:30 in the marathon.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Marathoners	Magnetic Resonance Imaging (MRI)	-

Primary Outcome Measures

Name	Time	Method
Fractional Anisotropy (FA) measure	at 4 days	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.

Secondary Outcome Measures

Name	Time	Method
Apparent Diffusion Coefficient (ADC) value	at 4 days

Trial Locations

Locations (1)

University Hospital of Montpellier; 🇫🇷 Montpellier Cedex 5, France