Prospective Cohort Study of Villarreal CF Youth Players
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-45
SponsorCardenal Herrera University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The target population includes active athletes, both in developmental stages and at the professional level, participating in sports with a high risk of ACL injury, such as soccer, basketball, handball, and volleyball. These disciplines share biomechanical patterns involving jumping, deceleration, and changes of direction that impose high loads on the knee joint complex, justifying their selection for the development of predictive models applicable across different sports contexts.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Villareal FC Group
Trial outcomes
Primary outcomes
1
Incidence of anterior cruciate ligament (ACL) injury
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.
Time frame
From baseline up to 36 months, across 3 consecutive seasons.Secondary outcomes
1
Landing Error Scoring System (LESS)
Assessment of landing biomechanics and neuromuscular control using the instrumented Landing Error Scoring System (LESS). It is a total score (a numerical score ranging from 0 to 17). Unit of measure: absolute value.
Time frame
From enrollment to the beginning and end of each season, across 36 months.2
Peak vertical force
Peak vertical force, The maximum impact force recorded along the vertical axis during landing. (unit of measure: Newton)
Time frame
From enrollment to the beginning and end of each season, across 36 months3
Time to peak force
Time to peak force: The time interval that elapses from the exact moment of initial ground contact until the peak vertical force (described above) is reached. Unit of measurement: Milliseconds (ms) or Seconds (s).
Time frame
From enrollment to the beginning and end of each season, across 36 months4
Loading Rate
Loading Rate, ndicates how rapidly force is applied to the body during impact. Mathematically, it is the slope of the force-time curve. Unit of measurement: Newtons per second (N/s).
Time frame
From enrollment to the beginning and end of each season, across 36 monthsSponsors and contacts
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Source ClinicalTrials.gov
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