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.

June 6, 2017 updated by: University Hospital, Montpellier
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier Cedex 5, France, 34295
        • University Hospital of Montpellier

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

25 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 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

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Marathoners
Device: Magnetic Resonance Imaging (MRI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fractional Anisotropy (FA) measure
Time Frame: 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.
at 4 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Apparent Diffusion Coefficient (ADC) value
Time Frame: at 4 days
at 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Sébastien BOMMART, University Hospital, Montpellier

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

March 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (ESTIMATE)

December 23, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9097

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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