Prospective Cohort Study of Villarreal CF Youth Players

NCT07653633 | Not Yet Recruiting

• 1 other identifier: CEEI25/769
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament (ACL) Tear; Anterior Cruciate Ligament (ACL)

Keywords

Anterior cruciate ligament; injuries; COL1A1; COL5A1; PIEZO1/2; gut microbiome

Outcome Measures

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.

  From baseline up to 36 months, across 3 consecutive seasons.

Secondary Outcomes (14)

• Landing Error Scoring System (LESS)

  From enrollment to the beginning and end of each season, across 36 months.

• Peak vertical force

  From enrollment to the beginning and end of each season, across 36 months

• Time to peak force

  From enrollment to the beginning and end of each season, across 36 months

• Loading Rate

  From enrollment to the beginning and end of each season, across 36 months

• Interlimb Asymmetries

  From enrollment to the beginning and end of each season, across 36 months

Study Arms (1)

Villareal FC Group

The target population includes active athletes, both male and female players, 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.

Eligibility Criteria

• Age: 10 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Villareal Football Club

Villarreal, Spain, 12540, Spain

Location

Related Publications (3)

• Oxfeldt M, Pedersen AB, Hansen M. Intra-Tester and Inter-Tester Reliability of the Lachmeter When Measuring Knee Joint Laxity. Transl Sports Med. 2023 Aug 8;2023:5583949. doi: 10.1155/2023/5583949. eCollection 2023.

  PMID: 38654920 BACKGROUND

• Posthumus M, September AV, O'Cuinneagain D, van der Merwe W, Schwellnus MP, Collins M. The association between the COL12A1 gene and anterior cruciate ligament ruptures. Br J Sports Med. 2010 Dec;44(16):1160-5. doi: 10.1136/bjsm.2009.060756. Epub 2009 May 13.

  PMID: 19443461 BACKGROUND

• Alam A, Neish A. Role of gut microbiota in intestinal wound healing and barrier function. Tissue Barriers. 2018;6(3):1539595. doi: 10.1080/21688370.2018.1539595. Epub 2018 Nov 7.

  PMID: 30404570 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

1. Non-invasive saliva collection using a buccal swab to analyze genetic variants associated with ligament integrity, collagen, inflammation, and mechanotransduction related to ACL rupture risk. 2. Stool sample collection follows a standardized biosafety and preservation protocol to be analyzed via 16S rRNA sequencing (V3-V4 region), in order to assess alpha and beta diversity, bacterial composition, and the presence of pro-inflammatory or tissue-recovery-modulating profiles.

MeSH Terms

Conditions

Lacerations; Wounds and Injuries

Study Officials

• Javier Martínez Gramage, Professor

  Cardenal Herrera University

  STUDY CHAIR

Central Study Contacts

Javier Martínez Gramage, Professor

CONTACT

+34617024366; jmg@uchceu.es

Flavia Ms Costantino, Student

CONTACT

+34634455845; flavia.costantino@alumnos.uchceu.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-05

Locations

ES (1)