Prospective Cohort Study of Villarreal CF Youth Players (NCT07653633) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prospective Cohort Study of Villarreal CF Youth Players
Spain200 participantsStarted 2026-07
Plain-language summary
Anterior cruciate ligament (ACL) injuries represent a highly relevant issue in both grassroots and professional sports, with a particularly high incidence in young and female populations. The objective of this project is to develop and validate a multiscale predictive algorithm for ACL injury risk in athletes from Villarreal CF (aged 10-45), integrating biomechanical, physiological, genetic, and gut microbiome biomarkers.
The study, with a prospective and longitudinal design (4 years), will include a cohort of 200-250 players from the academy and first team. The following assessments will be conducted: biomechanical analysis of jumps using force platforms (instrumented LESS), physiological monitoring through resting heart rate and nocturnal heart rate variability (HRV), genotyping from saliva samples, and characterization of the gut microbiome 16 rRNA sequencing. The systematic recording of training, exposures, and injuries will follow OSTRC criteria and will be supervised by the club's medical team.
The expected outcome is a multivariate predictive model, validated in a professional sports setting, capable of identifying individual risk profiles and generating a personalized score to guide preventive interventions (exercise, strength training, nutritional or probiotic strategies). This approach aims to reduce the incidence of ACL injuries, optimize performance, and translate biomedical knowledge into clinical and sports practice.
Who can participate
Age range
10 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Active federation license with Villarreal CF during the study period.
* Regular participation in training sessions and official competitions.
* Aged between 10 and 45 years (encompassing academy, youth development, and first-team categories).
* For participants under 18 years of age: mandatory written informed consent from a parent or legal guardian.
* For minor participants aged ≥12 years: written informed assent must be provided by the athlete in addition to parental consent.
Exclusion Criteria:
* Previous bilateral anterior cruciate ligament (ACL) reconstruction.
* Active severe musculoskeletal injury that prevents the execution of biomechanical or physiological testing.
* Systemic disease or medical condition that limits sports participation or interferes with the study's biological/physiological parameters.
* Deregistration or transfer to another sports club during the prospective follow-up period. Refusal or inability to comply with the protocol's testing procedures or long-term follow-up requirements.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of anterior cruciate ligament (ACL) injury
Timeframe: From baseline up to 36 months, across 3 consecutive seasons.