NCT06282341

Brief Summary

Road marathon is a famous running race known for hundreds of years. Trail running is an emerging running discipline which count new runners every year. Trail running and road marathon are two running endurance disciplines which differed by variation of elevation and nature of the terrain. While marathon is essentially run on flat roads, trail races are realized on steep paths (mountain, desert…) with an important variation of elevation. Neuromuscular, biomechanical and physiological consequences are different depending on the discipline, especially with a greater eccentric contribution in trail running. In spite of this characteristic, trail runners take part in several races longer than 40 km per year, while road runners participate in one to two marathons per year.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

October 23, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2025

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

October 23, 2023

Last Update Submit

March 9, 2026

Conditions

Keywords

RunningMarathonTrailFatigue

Outcome Measures

Primary Outcomes (1)

  • Change in knee extensors maximal isometric torque output

    The primary outcome will be changed (in % of baseline value) of the maximal voluntary torque (in Nm) produced by the knee extensors, measured at D0 (= day of the race) with an isometric knee dynamometer (ARS dynamometry, SP2, Ltd., Ljubljana, Slovenia), before (baseline value = 30 minutes before the race) and at the end (15 minutes after the race) of a marathon or a trail (depending on the group)

    Day 0 (day of the race) baseline value = 30 minutes before the race and 15 minutes after the race

Secondary Outcomes (19)

  • Change in plantar flexor maximal isometric torque output

    Day 0 (day of the race) baseline value = 30 minutes before the race and 15 minutes after the race, Days 1, 2, 7

  • Recovery of quadriceps maximal isometric torque output the month after the race

    Day 0 (day of the race) baseline value = 30 minutes before the race, (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).

  • Voluntary activation level

    D0 (day of the race) baseline value = 30 min before the race, in the middle of the race (except for the trail in the nature) and 15 min after the race;D1 = 24h after the end of the race , D2 = 48h after the end of the race, D7 = 7 days after the end

  • Force assessed in dynamic

    Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).

  • Velocity assessed in dynamic

    Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).

  • +14 more secondary outcomes

Study Arms (3)

MARASIM

ACTIVE COMPARATOR

During visit 2, road runners will take part in a simulated marathon race on a treadmill.

Other: Race: Simulated marathon

TRAILSIM

ACTIVE COMPARATOR

During visit 2, trail runners will take part in a simulated trail race on a treadmill.

Other: Race: Simulated trail

TRAILNAT

ACTIVE COMPARATOR

During visit 2, trail runners will take part in a real trail race in the nature.

Other: Race: Trail in nature

Interventions

Participants will take part in a race: simulated marathon. Before, during, immediately after and the month after the race, neuromuscular, physiological and biomechanical assessments will take place.

MARASIM

Participants will take part in a race: simulated trail. Before, during, immediately after and the month after the race, neuromuscular, physiological and biomechanical assessments will take place.

TRAILSIM

Participants will take part in a race: trail in nature. Before, during, immediately after and the month after the race, neuromuscular, physiological and biomechanical assessments will take place.

TRAILNAT

Eligibility Criteria

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

You may qualify if:

  • Common for MARASIM, TRAILSIM and TRAILNAT:
  • Male or female
  • years old
  • Endurance runners who run at least one running session of 20 km per week
  • Being able to run a marathon under 5 h or finishing a trail of 30 km during the last 3 years
  • Refrain from participating to a competition one month before the first visit and during the duration of the study
  • To have a medical certificate of no contraindication of running practise in competition
  • Registered with a social security scheme
  • Having given the written consent freely
  • Specific for the 3 groups :
  • Specialist of trail running (TRAILSIM and TRAILNAT)
  • Specialist of road running (MARASIM)

You may not qualify if:

  • Subjects who present cardiac or articular chronic pathologies (example: repeated sprain, patellar or joint problems)
  • Subjects who present chronic or central neurological pathologies
  • Subjects deprived of liberty or who should be legally deprived
  • Subjects who report to take forbidden products by the World Anti-Doping Agency
  • pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unités de Myologie et de Médecine du Sport

Saint-Etienne, France, 42055, France

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leonard FEASSON, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Prospective study on healthy volunteers, comparing the neurophysiological, physiological and biomechanical effects at the end of a marathon compared with an equivalent effort trail in the open air, or simulated on a treadmill, in runners specialising in each of the 2 disciplines
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2023

First Posted

February 28, 2024

Study Start

December 28, 2023

Primary Completion

December 3, 2025

Study Completion

December 17, 2025

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations