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Physiological Constraints Associated With Trail Running (UT4M2018)

Primary Purpose

Muscle Fatigue

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Pre and post running evaluations

About this trial

This is an interventional basic science trial for Muscle Fatigue

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

CHU Grenoble-Alpes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

160km

40km

100km

4x40km

Arm Description

Outcomes

Primary Outcome Measures

Quantification of the level of ankle extensors fatigue induced by trail

Pre-post-force decrease in muscle contractility of ankle extensors assessed by neurostimulation

Quantification of the level of knee extensors fatigue induced by trail

Pre-post-force decrease in muscle contractility of knee extensors assessed by neurostimulation

Quantification of the level of ankle extensors fatigue induced by trail

Pre-post-force decrease in muscle contractility of infarction assessed by echocardiography

Secondary Outcome Measures

Full Information

NCT ID

NCT03712592

First Posted

October 10, 2018

Last Updated

October 18, 2018

Sponsor

University Hospital, Grenoble

Collaborators

University Grenoble Alps

1. Study Identification

Unique Protocol Identification Number

NCT03712592

Brief Title

Physiological Constraints Associated With Trail Running

Acronym

UT4M2018

Official Title

Physiological Constraints Associated With Trail Running

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

July 23, 2018 (Actual)

Primary Completion Date

August 23, 2018 (Actual)

Study Completion Date

September 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Grenoble

Collaborators

University Grenoble Alps

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle Fatigue

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

160km

Arm Type

Experimental

Arm Title

40km

Arm Type

Experimental

Arm Title

100km

Arm Type

Experimental

Arm Title

4x40km

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Pre and post running evaluations

Intervention Description

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.

Primary Outcome Measure Information:

Title

Quantification of the level of ankle extensors fatigue induced by trail

Description

Pre-post-force decrease in muscle contractility of ankle extensors assessed by neurostimulation

Time Frame

one month and 12 days

Title

Quantification of the level of knee extensors fatigue induced by trail

Description

Pre-post-force decrease in muscle contractility of knee extensors assessed by neurostimulation

Time Frame

one month and 12 days

Title

Quantification of the level of ankle extensors fatigue induced by trail

Description

Pre-post-force decrease in muscle contractility of infarction assessed by echocardiography

Time Frame

one month and 12 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

CHU Grenoble-Alpes

City

Grenoble

ZIP/Postal Code

38043

Country

France

12. IPD Sharing Statement

Plan to Share IPD

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Physiological Constraints Associated With Trail Running

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