NCT07374016

Brief Summary

Finding the optimal training, i.e. the training that enables the athlete to achieve the best performance while preserving their physical and psychological integrity, is a multi-factorial issue. Each individual's background and training capacity are very different, hence the need for personalised training. The availability of data combined with advances in Artificial Intelligence (data modelling and analysis sciences, big data, machine learning, deep learning, etc.) offer the opportunity to refine our understanding of training and adapt recommendations according to the runner's profile for a given objective (achieving a time over a distance, completing an event, etc.). The strategy that the investigators wish to evaluate as part of this trial could make it possible to recommend an optimal training load, as well as the distribution of intensities (as a percentage of the aerobic threshold, anaerobic threshold, VVO2max, etc). The two features are (i) the personalisation will be based on training history, the level of the runner, age and gender, and the runner can focus on training, and (ii) the strategy will be adaptive, i.e. the algorithm will update the training load in real time based on contextual data about the athlete (level of fatigue via heart rate variability, feedback on recent training sessions, feelings of stress).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
1,209

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress11%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

January 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

January 21, 2026

Last Update Submit

January 21, 2026

Conditions

Endurance Training

Keywords

Trail runningPerformanceTraining recommendationsArtificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Comparison of the ITRA performance index

    The main criterion for assessing the improvement in trail running performance will be the increase in the ITRA performance index of users following PERSO-ADAPT compared with the increase in the ITRA score of PERSO and GEN. The ITRA Performance Index (PI) is a tool that estimates a runner's level of performance. The performance index can be used to compare the level of different trail runners around the world and is built on a scale up to a maximum of 1000 points. The top of the scale corresponds to the theoretical best possible level.

    Month : 10

Secondary Outcomes (6)

  • Number of injuries

    Weeks : 1 to 40

  • ROF (Rating-of-Fatigue Scale)

    Weeks : 1 to 40

  • RPE (Rating of Perceived Exertion)

    Weeks : 1 to 40

  • Hooper questionnaire

    Weeks : 1 to 40.

  • The '36-12' field test

    Weeks : 6, 13, 20, 27, 34, 40.

  • +1 more secondary outcomes

Study Arms (3)

GEN: generic training plan group

ACTIVE COMPARATOR

The GEN group will follow a generic training plan that will be created from a platform that is both free and popular, offering training plans for trail-running (The Decathlon Pacer application).

Procedure: Training recommendations GEN

PERSO: non-adaptive personalized group

ACTIVE COMPARATOR

The PERSO group will follow a plan that takes into consideration the training history, in particular the number of hours per week over the previous two years; the runner's level; age and sex; time available for training; and access to mountainous terrain.

Procedure: Training recommendations PERSO

PERSO-ADAPT group: adaptive personalized group

EXPERIMENTAL

The PERSO-ADAPT group will include the same information as the PERSO group, but the training will also be adapted on a weekly basis according to the following feedback: state of fatigue assessed by questionnaire and heart rate variability; state of overtraining, assessed by questionnaire; degree of session completion).

Procedure: Training recommendations PERSO-ADAPT

Interventions

Training recommendations GENPROCEDURE

Generic training plan that will be created from a platform that is both free and popular, offering training plans for trail-running (The Decathlon Pacer application).

GEN: generic training plan group
Training recommendations PERSOPROCEDURE

A training plan that takes into account the rider's training history, in particular the number of hours per week over the last two years, the rider's level, age and gender, the time available for training and access to mountainous terrain.

PERSO: non-adaptive personalized group
Training recommendations PERSO-ADAPTPROCEDURE

A training plan that takes into account the rider's training history, in particular the number of hours per week over the last two years, the level, age and gender of the rider, the time available for training and access to mountainous terrain. Training will also be adapted on a weekly basis according to the following feedback: state of fatigue assessed by questionnaire and heart rate variability; state of overtraining, assessed by questionnaire; degree of completion of sessions.

PERSO-ADAPT group: adaptive personalized group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have no contraindications to trail running (Fédération Française d'Athlétisme test procedures)
  • Have been trail running competitively for at least 1 year
  • In possession of an ITRA performance index
  • Intends to run at least one ITRA-indexed race in the second half of the follow-up period
  • Own a training watch, and intend to record all training sessions of more than 10 minutes in their shared database
  • Have freely given their written consent.

You may not qualify if:

  • Any person with chronic joint pathologies (e.g. recurrent sprains, patellar or ligament problems) or cardiac pathologies.
  • Any person with chronic or central neurological pathologies.
  • Any person deprived of their liberty or under legal protection (guardianship, curatorship, safeguard of justice, family habilitation).

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

Study Officials

  • Leonard FEASSON, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonard FEASSON, MD PhD

CONTACT

(0)4 77 12 03 83leonard.feasson@chu-saint-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Longitudinal, controlled, randomised, prospective study by downloading training data and questionnaires via smartphone.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 28, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)