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Clinical Trials in Spain / NCT07653633
Starting soon Observational

Prospective Cohort Study of Villarreal CF Youth Players

NCT07653633 · tracked via the Priya Life Science Spain tracker
Sponsor
Cardenal Herrera University
Phase
Observational
Started
2026-07
Last updated
2026-06-17

Condition(s) studied

Anterior Cruciate Ligament (ACL) TearAnterior Cruciate Ligament (ACL)

Study 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.

Eligibility

Sex
ALL
Min age
10 Years
Max age
45 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of anterior cruciate ligament (ACL) injury — From baseline up to 36 months, across 3 consecutive seasons.
    Number of new acute ACL injuries confirmed clinically and radiologically by the medical staff, recorded alongside total training and match exposure hours to calculate injury rates. Unit of measure: absolute number.

Trial sites (1)

FacilityCityRegionStatus
Villareal Football Club Villarreal Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07653633 on ClinicalTrials.gov ↗ ← All trials in Spain