Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06325228
Other study ID # NKBBN/241/2023
Secondary ID SONP/SP/549693/2
Status Active, not recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date September 1, 2025

Study information

Verified date April 2024
Source Medical University of Gdansk
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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?


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.).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 373
Est. completion date September 1, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 16 Years
Eligibility 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 Design


Locations

Country Name City State
Poland Department of Immunobiology and Environment Microbiology, Medical University of Gdansk Gdansk

Sponsors (2)

Lead Sponsor Collaborator
Medical University of Gdansk Ministry of Science and Higher Education, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Sport workload (hours per trainings or competition) Sports and training volume (hours per trainings or competition, weekly) through study completion, an average of 1 year
Other Peak Height Velocity Peak Height Velocity (PHV) calculated using the 'maturity offset' value (report as "PHV years") - Mirwald formula through study completion, an average of 1 year
Other Sports discipline and position Sport discipline (e.g. soccer) and Sports position (e.g. on the soccer field: defender) through study completion, an average of 1 year
Other Participants characteristics - Body Mass Index weight and height will be combined to report BMI in kg/m^2 through study completion, an average of 1 year
Other Sports experience Sports experience (years, months) through study completion, an average of 1 year
Primary 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
Primary 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 Sports Specialization 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
Secondary History of sports-related injuries Questionaire - Question about sports-related injuries within sports career (sports participating in trainings and competitions) which included:
- 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)
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
Secondary Health-related quality of life: EQ-5D-Y 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
Secondary Y-Balance Test - dynamic balance test 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
Secondary Functional Movement Screen (FMS) 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
Secondary Hand-Held Dynamometer (HHD) measurement - Isometric Strength of the lower extremities muscle 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
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1