NCT06805162

Brief Summary

In athletics, injuries can affect athletes' participation in athletics, their performance and career, but also their health in physical, psychological and social aspects, in the short, medium and long term.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
643

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

January 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

February 7, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2025

Completed
Last Updated

April 29, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

January 28, 2025

Last Update Submit

April 25, 2025

Conditions

Keywords

NEURO MUSCULARAthleticsinjury prevention

Outcome Measures

Primary Outcomes (1)

  • Time (day) until the first Injury-type Complaint related to athletics and resulting in Restricted Participation in athletics (ICRP)

    Time in days during which athletes are free of ICRP, between an intervention group and a control group

    Week 14

Secondary Outcomes (4)

  • Number of ICRP per 1000 hours of athletics practice

    Week 14

  • Number of days with an ICRP per 1000 hours of athletics practice

    Week 14

  • Percentage of athletes with at least one ICRP

    Week 14

  • The average percentage of athletes with at least one ICRP

    Week 14

Study Arms (2)

Specific training

EXPERIMENTAL

there will be a multi-domain intervention: i) A series of 12 educational videos on injury prevention; ii) Neuro-muscular exercise-based injury prevention programmes; iii) Techniques against stress and anxiety through breathing and mindfulness practice; iv) Injury prognostic feedback using individual data and based on a machine learning model.

Other: Specific training

Normal training

ACTIVE COMPARATOR

Athletes who continue their normal training

Other: Normal training

Interventions

Athletes should continue their normal training

Normal training

Athletes should consider i) watching the educational videos on injury prevention, ii) perform the neuro-muscular exercises, iii) practice the techniques against stress and anxiety, and iv) consider the injury prognostic feedback.

Specific training

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • be licensed at the French Athletics Federation (FFA) for competition (sprints, hurdles, jumps, throws, combined events, and endurance disciplines), without any counter-indications for competitive athletics activity attested by the license at the FFA;
  • have daily access to a digital device (smartphone, computer, tablet) with a network connection (public or private).

You may not qualify if:

  • Any athlete deprived of liberty or subject to legal protection (guardianship, under curatorship, legal protection).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • PASCAL EDOUARD, MD-PHD

    CENTRE HOSPITALIER DE SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 3, 2025

Study Start

February 7, 2025

Primary Completion

July 21, 2025

Study Completion

July 21, 2025

Last Updated

April 29, 2025

Record last verified: 2025-02

Locations