InjuryI-ReductAINCT06805162
Effect of an Unsupervised Multi-domain Intervention on Injury Risk Reduction in Athletics (I-ReductAI).
A study testing Normal training and Specific training in people with Injury, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury
- What is being tested?
- Normal training and Specific training
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 643 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2025to 21 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Any athlete deprived of liberty or subject to legal protection (guardianship, under curatorship, legal protection).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Injury
- Being tested
- Normal training, Specific training
- Keywords
- NEURO MUSCULAR, Athletics, injury prevention
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal trainingOther
Athletes should continue their normal training
Specific trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Specific training |
| Normal training | Active comparator | Athletes who continue their normal training Receives: Other: Normal training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 14
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start7 Feb 2025
- Primary completion21 Jul 2025 (estimated)
- Study completion21 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 643 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Etienne School of Mine
- Responsible party
- Sponsor
- Investigators
- PASCAL EDOUARD, MD-PHD, Principal investigator, CENTRE HOSPITALIER DE SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805162
- Sponsor's protocol ID
- 24CH262
- Acronym
- I-ReductAI
- Status last verified
- Feb 2025
- First submitted
- 28 Jan 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Unsupervised Multi-domain Intervention on Injury Risk Reduction in Athletics: Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06805162
- Acronym / sponsor ID
- I-ReductAI / 24CH262
- Conditions
- Injury
- Keywords
- NEURO MUSCULAR, Athletics, injury prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 643 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Saint Etienne School of Mine
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 21 Jul 2025 (estimated)
- Study completion
- 21 Jul 2025 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific training | Experimental | Other: Specific trainingthere 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. |
| Normal training | Active comparator | Other: Normal trainingAthletes who continue their normal training |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Any athlete deprived of liberty or subject to legal protection (guardianship, under curatorship, legal protection).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal trainingAthletes should continue their normal training | Other | Normal training |
| Specific trainingAthletes 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. | Other | Specific training |
Primary outcome
Time (day) until the first Injury-type Complaint related to athletics and resulting in Restricted Participation in athletics (ICRP)
Time frame: Week 14
Time in days during which athletes are free of ICRP, between an intervention group and a control group
4 secondary outcomes
Number of ICRP per 1000 hours of athletics practice
Time frame: Week 14
Number of days with an ICRP per 1000 hours of athletics practice
Time frame: Week 14
Percentage of athletes with at least one ICRP
Time frame: Week 14
The average percentage of athletes with at least one ICRP
Time frame: Week 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PASCAL EDOUARD, MD-PHD principal investigator
CENTRE HOSPITALIER DE SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal training and Specific training in people with Injury, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (day) until the first Injury-type Complaint related to athletics and resulting in Restricted Participation in athletics (ICRP) (time frame: Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.