A Single-season Prospective Observational Cohort Study of the Villarreal CF Male Youth Academy"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
Study Overview
Brief 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.
Detailed Description
Quality Assurance Plan: The quality of the data and project processes is guaranteed through a centralized technological infrastructure and a strict biological sample traceability protocol. The pseudonymized database is hosted within the institutional cloud-based data infrastructure of the CEU Cardenal Herrera University (UCH-CEU). The system implements restricted access control through personal, non-transferable credentials, institutional authentication, and automated operation logging (activity logs). The laboratories responsible for biological processing (saliva and stool) operate under international quality certifications ISO 9001, ISO 15189, and ISO 27001. Additionally, the genetic bioinformatic analysis integrates an automated quality control system (QC-System) that filters and validates genetic variants based on international standards (call rate >98%, Hardy-Weinberg equilibrium, and minor allele frequency/MAF).
Data Checks:Automated and manual consistency checks are applied across the different analytical dimensions. In the bioinformatic layer, the AIG (Automated Intelligence Genetics) platform executes automatic duplication checks and filters artifacts during DNA sequencing. In the microbiome dimension, the bioinformatic workflow utilizes QIIME2® and DADA2 tools alongside positive controls (standard microbial communities) and negative controls (blank extractions) to identify and correct methodological biases or batch effects. For the biomechanical (LESS test) and clinical assessments (Lachmeter®), three valid trials are performed per participant, and the measurements are averaged, verifying internal consistency via the intraclass correlation coefficient (ICC), standard error of measurement (SEM), and smallest detectable change (SDC).
Source Data Verification (SDV):The study design requires cross-referencing records with external platforms to ensure the accuracy of longitudinal information. Daily physiological data (resting heart rate and nocturnal heart rate variability) are automatically synchronized from the WHOOP Strap 4.0 wearable devices to the internal monitoring platform of Villarreal CF. Furthermore, the primary variable-injury incidence-is verified through direct clinical confirmation by the Villarreal CF medical team following the club's standardized diagnostic criteria, which are prospectively contrasted against weekly exposure records filled out under technical staff supervision.
Data Dictionary:The protocol defines a set of multiscale variables coded under a unique alphanumeric code for each participant, omitting any directly identifiable information.
The variable dictionary explicitly includes:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to 45 Years (Child, Adult)
- Sex
- All
- Accepts 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.
Investigators
JAVIER MARTI NEZ-GRAMAGE
Professor
Cardenal Herrera University