NCT03712592

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2018

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 10, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

October 10, 2018

Last Update Submit

December 19, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Quantification of the level of ankle extensors fatigue induced by trail

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

    one month and 12 days

  • Quantification of the level of knee extensors fatigue induced by trail

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

    one month and 12 days

  • Quantification of the level of ankle extensors fatigue induced by trail

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

    one month and 12 days

Study Arms (4)

160km

EXPERIMENTAL
Other: Pre and post running evaluations

40km

EXPERIMENTAL
Other: Pre and post running evaluations

100km

EXPERIMENTAL
Other: Pre and post running evaluations

4x40km

EXPERIMENTAL
Other: Pre and post running evaluations

Interventions

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.

100km160km40km4x40km

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Man or woman
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble-Alpes

Grenoble, 38043, France

Location

Related Publications (1)

  • Besson T, Rossi J, LE Roux Mallouf T, Marechal M, Doutreleau S, Verges S, Millet GY. Fatigue and Recovery after Single-Stage versus Multistage Ultramarathon Running. Med Sci Sports Exerc. 2020 Aug;52(8):1691-1698. doi: 10.1249/MSS.0000000000002303.

MeSH Terms

Interventions

Lead

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 19, 2018

Study Start

July 23, 2018

Primary Completion

August 23, 2018

Study Completion

September 5, 2018

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations