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OpenTrials
Completed

NCT Number: NCT02018718

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.

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).

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Key information

Conditions

Marathoners

Age range

25 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic Resonance Imaging (MRI)

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. Apparent Diffusion Coefficient (ADC) value

    Time frame: at 4 days

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2013
Registry last updated
Jun 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.