NCT06325228

Brief Summary

The primary aim of this observational cohort study is to assess sports specialization, sports performance, history of injuries (prevalence, types, areas, duration) and quality of life in young healthy athletes aged 8-16 from Poland. Athlete profiles will be created based on the variables (explained in detailed description) examined. Furthermore, the investigators will perform one-year injury follow-up. The main questions it aims to answer are:

  • Do athletes with a specific profile (lower values in athletic performance tests, low values in quality of life) evaluated at one time point, suffer injury in the future in annual observation?
  • Do athletes with high sports specialization will sustain injury in one-year follow-up?
  • Does sports specialization have a relationship with sports performance tests, and quality of life?
  • Does sport specialisation, training volume, geographical factor relate to injury history?
  • Does sports specialisation, injury history differ between sports (individual and team sports)?
  • Does value of the specific muscle (lower limb) isometric strength will be associated with the dynamic balance scores in young healthy athletes?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
373

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

2.9 years

First QC Date

March 10, 2024

Last Update Submit

December 22, 2025

Conditions

Keywords

Sports specializationYoung AthletesInjury preventionSports performance

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with sports injury after one-year follow-up

    Dichotomous assessment (0 = no injury, 1 = injury) based on a telephone interview with the parent/guardian/coach. Conditions to meet: 12 months after the date of examination, and continuity of participation in sports to the date of injury

    One year after the date of examination

  • Type, location, duration, and return to sports in participants with injury at one-year follow up

    Assessment based on a telephone interview with the parent/guardian/coach. Questions about: * exact type of injury (acute or chronic, contact or non-contact) * location of injury (anatomic site, e.g. knee) * duration of injury (time-loss, in days) * return to sports (Does the participant return to sport, yes or no)

    One year after the date of examination

Secondary Outcomes (6)

  • Sports Specialization

    through study completion, an average of 1 year

  • History of sports-related injuries

    through study completion, an average of 1 year

  • Health-related quality of life: EQ-5D-Y

    through study completion, an average of 1 year

  • Y-Balance Test - dynamic balance test

    through study completion, an average of 1 year

  • Functional Movement Screen (FMS)

    through study completion, an average of 1 year

  • +1 more secondary outcomes

Other Outcomes (5)

  • Sport workload (hours per trainings or competition)

    through study completion, an average of 1 year

  • Peak Height Velocity

    through study completion, an average of 1 year

  • Sports discipline and position

    through study completion, an average of 1 year

  • +2 more other outcomes

Study Arms (1)

Young Athletes

300 young athletes (boys and girls, 9 - 16 years-old) from clubs, teams, associations, sports classes of various disciplines in the Pomeranian Voivodeship

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Young healthy athletes (8-16 years-old) from sports schools, clubs, teams from the territory of the Pomeranian voivodeship, Poland.

You may qualify if:

  • Healthy (without injury, pain, or symptoms)
  • Participation in sports activities (minimum 6 months)
  • Age of 8 to 16 years-old
  • Agreement to participation from parent/guardian

You may not qualify if:

  • pain or other symptoms related during study
  • lower extremity or trunk surgery in the last 6 months
  • lack of medical approval for participation in sports games

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Immunobiology and Environment Microbiology, Medical University of Gdańsk

Gdansk, 80-211, Poland

Location

Related Publications (5)

  • Wilczynski B, Radziminski L, Sobierajska-Rek A, de Tillier K, Bracha J, Zorena K. Biological Maturation Predicts Dynamic Balance and Lower Limb Power in Young Football Players. Biology (Basel). 2022 Aug 3;11(8):1167. doi: 10.3390/biology11081167.

    PMID: 36009793BACKGROUND
  • Wilczynski B, Radziminski L, Sobierajska-Rek A, Zorena K. Association between Selected Screening Tests and Knee Alignment in Single-Leg Tasks among Young Football Players. Int J Environ Res Public Health. 2022 May 31;19(11):6719. doi: 10.3390/ijerph19116719.

    PMID: 35682301BACKGROUND
  • Bruzda R, Wilczynski B, Zorena K. Knee function and quality of life in adolescent soccer players with Osgood Shlatter disease history: a preliminary study. Sci Rep. 2023 Nov 6;13(1):19200. doi: 10.1038/s41598-023-46537-7.

    PMID: 37932373BACKGROUND
  • Wilczynski B, Hinca J, Slezak D, Zorena K. The Relationship between Dynamic Balance and Jumping Tests among Adolescent Amateur Rugby Players. A Preliminary Study. Int J Environ Res Public Health. 2021 Jan 4;18(1):312. doi: 10.3390/ijerph18010312.

    PMID: 33406658BACKGROUND
  • Wilczynski B, Buler J, Buler RL, Grochowski ML, Puchalski B, Zorena K. Strength and balance asymmetries in children and adolescents: comparison between single- and multi-sport participants. BMC Sports Sci Med Rehabil. 2025 Nov 27;17(1):358. doi: 10.1186/s13102-025-01420-y.

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Bartosz Wilczyński, phD

    Department of Immunobiology and Environment Microbiology, Medical University of Gdańsk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2024

First Posted

March 22, 2024

Study Start

February 1, 2023

Primary Completion

December 20, 2025

Study Completion

December 20, 2025

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The data that will be collected include data sets, i.e., personal survey questionnaires, measurement scales, functional and anthropometric assessment measurements, described in the description section of the scientific activity. Part of the data will be published in the public repository of the Polish Medical Research Platform and the Zenodo repository. Part of the data will be published in scientific journals, which may also require publication of raw data. Data will be made available at the latest at the time of publication. Data are available indefinitely at Polish Medical Research Platform and the Zenodo repository.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Immediately following publication. No end date
Access Criteria
Anyone who wishes to access the data

Locations