- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06325228
Musculoskeletal Injuries, Sports Performance, Sports Specialization, and Quality of Life in Young Athletes
Incidence and Relationshipis of Musculoskeletal Injuries, Sports Performance, Sports Specialization, and Quality of Life in Young Athletes. Project: "Science of Healthy Sport"
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?
Study Overview
Status
Conditions
Detailed Description
Recruited young healthy athletes (8-16 years-old) from sports schools, clubs, teams will invited to study. There will be performed assessment, which included:
- participant characteristics (age, biological age, gender, height, weight, body mass index, sports experience, training workload, sports specialization, history of injuries)
- sports performance (value of dynamic balance, isometric strength of lower limbs, functional movement patterns)
- quality of life and health assessment (EQ-5D-Y)
- geographical factor (Rural, Urban)
- Sports (Individual, Team)
- History of Injuries (Localization, Type)
One-year after meetings, there will be send questionaire and phone-call to participants and their coaches/parents in order to obtain information about injuries (location, type, time-loss, etc.).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Gdańsk, Poland, 80-211
- Department of Immunobiology and Environment Microbiology, Medical University of Gdańsk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with sports injury after one-year follow-up
Time Frame: One year after the date of examination
|
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
Time Frame: One year after the date of examination
|
Assessment based on a telephone interview with the parent/guardian/coach. Questions about:
|
One year after the date of examination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sports Specialization
Time Frame: through study completion, an average of 1 year
|
Sports specialization defined as "intensive year-round training in a single sport at the exclusion of other sports".
Where a highly specialized athlete may be able to (1) choose a main sport, (2) participate for greater than 8 months per year in 1 main sport, and (3) quit all other sports to focus on 1 sport.
|
through study completion, an average of 1 year
|
History of sports-related injuries
Time Frame: through study completion, an average of 1 year
|
Questionaire - Question about sports-related injuries within sports career (sports participating in trainings and competitions) which included:
Answers will be performed from young athlete and coach. If there will be occasion, answers will be matched with answers from parents/guardians. |
through study completion, an average of 1 year
|
Health-related quality of life: EQ-5D-Y
Time Frame: through study completion, an average of 1 year
|
Patient Reported Outcome instruments" EQ-5D-Y - EuroQol Research Foundation - Certified Translation: Polish for Poland.
The EQ-5D is a widely used standardized generic measure of HRQOL.
A valid and accurate translation of the corresponding original document.
A child-friendly version of the EQ-5D (0-100 points, where "0" means the worse quality of life, and "100" means perfect).
(EQ-5D is the name of the instrument and is not an acronym.)
|
through study completion, an average of 1 year
|
Y-Balance Test - dynamic balance test
Time Frame: through study completion, an average of 1 year
|
Dynamic Balance of the lower extremities (record as reach distance in centimeters "cm" and normalized reach distance in percentages "%")
|
through study completion, an average of 1 year
|
Functional Movement Screen (FMS)
Time Frame: through study completion, an average of 1 year
|
The Functional Movement Screen (FMS) is a screening tool used to identify limitations or asymmetries in movement patterns.
FMS consists of 7 movement tasks (deep squat, lunges, hurdle steps, a push-up, straight-leg raises, shoulder mobility, and rotary stability).
Each task will be visually assessed by an experienced physiotherapist and marked on a 4-point scale (0-3, worst-best).
The total maximum score that can be obtained is 21 points.
|
through study completion, an average of 1 year
|
Hand-Held Dynamometer (HHD) measurement - Isometric Strength of the lower extremities muscle
Time Frame: through study completion, an average of 1 year
|
Hand-Held Dynamometer (HHD) measurement (Laffayette, USA).
Isometric Strength (peak force, average force (kilograms), of the lower extremities muscle (gluteus medium, quadriceps, hamstring, triceps surae.
|
through study completion, an average of 1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sport workload (hours per trainings or competition)
Time Frame: through study completion, an average of 1 year
|
Sports and training volume (hours per trainings or competition, weekly)
|
through study completion, an average of 1 year
|
Peak Height Velocity
Time Frame: through study completion, an average of 1 year
|
Peak Height Velocity (PHV) calculated using the 'maturity offset' value (report as "PHV years") - Mirwald formula
|
through study completion, an average of 1 year
|
Sports discipline and position
Time Frame: through study completion, an average of 1 year
|
Sport discipline (e.g.
soccer) and Sports position (e.g. on the soccer field: defender)
|
through study completion, an average of 1 year
|
Participants characteristics - Body Mass Index
Time Frame: through study completion, an average of 1 year
|
weight and height will be combined to report BMI in kg/m^2
|
through study completion, an average of 1 year
|
Sports experience
Time Frame: through study completion, an average of 1 year
|
Sports experience (years, months)
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bartosz Wilczyński, phD, Department of Immunobiology and Environment Microbiology, Medical University of Gdańsk
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NKBBN/241/2023
- SONP/SP/549693/2022 (Other Grant/Funding Number: Minister of Education and Science)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaActive, not recruitingImprove Quality of LifeItaly
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
-
Linkoeping UniversityRecruiting
-
South Valley UniversityActive, not recruitingDeterminants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRSHealth Related Quality of LifeEgypt
-
Region VästmanlandUnknownHealth Related Quality of Life