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Physiological Constraints Associated With Trail Running (UT4M2018)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03712592
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
University Grenoble Alps
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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Brief Summary:
The practice of mountain running or "trail" is in full development in France and elsewhere in the world. This sporting practice associates specific physiological constraints related in particular to the duration of the efforts made (several hours) and to the ground (important elevation, technical ground, average altitude). Some studies have allowed the last 10 years to initiate the exploration of the physiological consequences of this type of practice, especially from a muscular point of view. However, some important questions remain to be clarified such as the impact of these sports events on fatigue and muscle recovery, cardiovascular, energy and water balance disturbances caused, induced sleep changes and the kinetics of recovery of the various parameters. . These elements remain in particular to be studied in very different racing contexts as currently developed by the organizers, namely race in one stage from long to very long distances (40 to 160 km) and race in stages (4 days, 4 x 40 km) as encountered in the Grenoble UT4M race (Ultra Tour des 4 Massifs).

Condition or disease Intervention/treatment Phase
Muscle Fatigue Other: Pre and post running evaluations Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Physiological Constraints Associated With Trail Running
Actual Study Start Date : July 23, 2018
Actual Primary Completion Date : August 23, 2018
Actual Study Completion Date : September 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arms and Interventions
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Arm Intervention/treatment
Experimental: 160km Other: Pre and post running evaluations

Each visit will include a series of neuromuscular, cardiovascular, blood glucose and body composition evaluations will be performed. The subjects will provide some information about their muscular pain and their food and water intake.

Finally, for the study of sleep that only concerns participants in the 4x40 km race, a home sleep registration banner will be given to each participant of the event step by step at the arrival of each stage in order to study sleep the next night as well as 2 nights after the arrival of the last stage.
Experimental: 40km Other: Pre and post running evaluations

Each visit will include a series of neuromuscular, cardiovascular, blood glucose and body composition evaluations will be performed. The subjects will provide some information about their muscular pain and their food and water intake.

Finally, for the study of sleep that only concerns participants in the 4x40 km race, a home sleep registration banner will be given to each participant of the event step by step at the arrival of each stage in order to study sleep the next night as well as 2 nights after the arrival of the last stage.
Experimental: 100km Other: Pre and post running evaluations

Each visit will include a series of neuromuscular, cardiovascular, blood glucose and body composition evaluations will be performed. The subjects will provide some information about their muscular pain and their food and water intake.

Finally, for the study of sleep that only concerns participants in the 4x40 km race, a home sleep registration banner will be given to each participant of the event step by step at the arrival of each stage in order to study sleep the next night as well as 2 nights after the arrival of the last stage.
Experimental: 4x40km Other: Pre and post running evaluations

Each visit will include a series of neuromuscular, cardiovascular, blood glucose and body composition evaluations will be performed. The subjects will provide some information about their muscular pain and their food and water intake.

Finally, for the study of sleep that only concerns participants in the 4x40 km race, a home sleep registration banner will be given to each participant of the event step by step at the arrival of each stage in order to study sleep the next night as well as 2 nights after the arrival of the last stage.


Outcome Measures
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Primary Outcome Measures :
  1. Quantification of the level of ankle extensors fatigue induced by trail [ Time Frame: one month and 12 days ]
    Pre-post-force decrease in muscle contractility of ankle extensors assessed by neurostimulation

  2. Quantification of the level of knee extensors fatigue induced by trail [ Time Frame: one month and 12 days ]
    Pre-post-force decrease in muscle contractility of knee extensors assessed by neurostimulation

  3. Quantification of the level of ankle extensors fatigue induced by trail [ Time Frame: one month and 12 days ]
    Pre-post-force decrease in muscle contractility of infarction assessed by echocardiography


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Man or woman
  • 18-55 years
  • Absence of chronic cardiovascular, respiratory, metabolic or neuromuscular disease
  • > 3 years of trail running (at least 1 race> 40 km / year completed and a race> 100 km completed (trail group 160 km)
  • Medical certificate of no contraindication to the practice of the trail
  • Subjects available in Grenoble before and within 15 days after the race
  • Subjects affiliated to a social security scheme
  • Subjects able to sign informed consent.

Exclusion Criteria:

  • Cardiorespiratory, metabolic and neurological diseases
  • Non-Echogenic Subjects
  • Subjects with chronic sleep disorders
  • Psychiatric pathologies or ATCD of behavioral disorders
  • Persons refusing to sign the information sheet and the participation agreement,
  • persons under guardianship or not subject to a social security scheme,
  • Pregnant woman, parturient, breastfeeding mother
  • Person deprived of liberty by judicial or administrative decision,
  • Person subject to a legal protection measure, who can not be included in clinical trials.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712592


Locations
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France
CHU Grenoble-Alpes
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
University Grenoble Alps
More Information
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03712592    
Other Study ID Numbers: 38RC18.096
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue