NCT05389111

Brief Summary

Determination of the effect of an intervention to develop the use of internal discourses on the perception of exercise during a sub-maximum effort following a trail running

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2025

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

2.2 years

First QC Date

April 29, 2022

Last Update Submit

December 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perception of effort during running.

    Perception of Borg scale rated effort (0 no effort; 10, maximal effort) while running on a treadmill at sub-maximum intensity

    1 day

Secondary Outcomes (8)

  • Psychological profiles of trail-running practitioners

    18 months

  • Perception of effort depending on running distance

    18 months

  • Link between the individual's physical level and perception of effort

    18 months

  • Serological library

    18 months

  • Performance on a cognitive task

    3 months

  • +3 more secondary outcomes

Study Arms (2)

Internal discourses

EXPERIMENTAL

Introduction to internal discourses with a brief definition and key elements for implementation.

Other: Internal discourses

Non-internal discourses

SHAM COMPARATOR

Introduction to the risks associated with the practice of activity in the mountain environment and practical tips to prevent the risks

Other: Non internal discourses

Interventions

This intervention will take place following the randomization performed at the V1 visit. It will be held in videoconference, will be led by a professional of the training field, specialist of the trail activity and trained in the use of mental strategies

Internal discourses

This intervention will take place following the randomization performed at the V1 visit. It will be held in videoconference, and will be conducted by a professional of the training field, specialist of the trail activity and coach of mountain guide

Non-internal discourses

Eligibility Criteria

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

You may qualify if:

  • Male or female
  • years
  • Subjects available in Grenoble before and during the 15 days after the race
  • Subjects subject to a social security scheme
  • Subjects able to sign informed consent.
  • Fluent in French

You may not qualify if:

  • Cardiorespiratory, metabolic and neurological conditions
  • People treated with anxiolytics and/or neuroleptics or ATCD for behavioural disorders
  • Persons refusing to sign the participation consent
  • Persons under guardianship
  • Persons referred to in Articles L1121-5 to L1121-8 of the CSP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2022

First Posted

May 24, 2022

Study Start

May 15, 2023

Primary Completion

July 25, 2025

Study Completion

July 25, 2025

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations