Effect of an Unsupervised Multi-domain Intervention on Injury Risk Reduction in Athletics (I-ReductAI). (I-ReductAI)

Effect of an Unsupervised Multi-domain Intervention on Injury Risk Reduction in Athletics: Protocol of a Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Injury
• Intervention / Treatment: Other: Specific training; Other: Normal training

Detailed Description

This justifies the development and implementation of injury risk reduction strategies. These should be developed according to a holistic approach that considers the complex aetiology of injuries in sport. Although many different injury risk reduction strategies have been studied in sport, in general, each has been evaluated in isolation, including for example education, neuromuscular exercises, psychological techniques or individual injury risk assessment. The investigators therefore hypothesized that their combination could improve the overall effectiveness of an intervention aimed at reducing the risk of injuries in athletics.

• Study Type: Interventional
• Enrollment (Actual): 643
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42055
    • Centre Hospitalier Universitaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Specific training; 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; 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.
Active Comparator: Normal training; Athletes who continue their normal training	Other: Normal training; Athletes should continue their normal training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of ICRP per 1000 hours of athletics practice	The number of ICRP per 1000 hours of athletics practice during a summer athletics competition season (14 weeks)	Week 14
Number of days with an ICRP per 1000 hours of athletics practice	Number of days with ICRP per 1000 hours of athletics practice) during a summer athletics competition season (14 weeks)	Week 14
Percentage of athletes with at least one ICRP	The percentage of athletes with at least one ICRP during a summer athletics competition season (14 weeks)	Week 14
The average percentage of athletes with at least one ICRP	The average percentage of athletes with at least one ICRP per week during a summer athletics competition season (14 weeks)	Week 14

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Ecole des Mines de Saint-Etienne
• Investigators: Principal Investigator: PASCAL EDOUARD, MD-PHD, CENTRE HOSPITALIER DE SAINT-ETIENNE

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2025
• Primary Completion (Estimated): July 21, 2025
• Study Completion (Estimated): July 21, 2025

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: injury prevention; Athletics; NEURO MUSCULAR
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 24CH262

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No