Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05471297
Other study ID # PPDC-2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 20, 2022
Est. completion date September 1, 2023

Study information

Verified date March 2024
Source University of Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Primary goal of the research is to determine whether injury/illness occurrence is influenced by the academic, training and competition loads, as well as the overall load (sum of academic/work, training and competition loads) in elite handball athletes To examine whether subjective measures of perceived overall stress correlate with objectively measured levels of stress. Determine the benefits of certain biomarkers to monitor stress, load and injury/illness occurrence in athletes.


Description:

The current structure and organizational initiatives do not meet the needs of athletes as they face different challenges throughout their careers. There is a need for better health surveillance, load monitoring and support services with a focus on injury/illnesses prevention and rehabilitation. The main goal of the research is to determine how specific loads affect the occurrence of injuries and illnesses in elite handball players and how much of the total load an athlete can withstand before an injury/illness occurs. Thus, the study will attempt to identify athletes at risk of injury/illness by monitoring their workload with subjective (perceived stress) and objective (biomarkers, hours of workload) measurements. One of the goals is also to determine the correlation between objective measures of stress (biomarkers) and subjective measures of stress (athlete's stress assessment). The results will not only be important for the medical and sports community for development of new injury prevention and rehabilitation strategies, but also for structuring the correct policy recommendations for athletes' general health. The research will be carried out on approx. 250 elite handball players (the entire 1st men's handball league) during one handball season. In addition to other parameters (monitoring of load, injuries and illnesses), blood samples will be taken from athletes at five time points according to their training cycle.


Recruitment information / eligibility

Status Completed
Enrollment 189
Est. completion date September 1, 2023
Est. primary completion date June 4, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - At least national-level handball players above 18 years of age, who are in a dual-career setting. - Handball players older than 18 years old, who are competing at least at national level and are not in a dual-career setting will be matched by their demographic characteristics and included in the control group. Exclusion Criteria: - Not fulfilling inclusion critieria

Study Design


Intervention

Other:
There is no intervention
There is no any intervention

Locations

Country Name City State
Slovenia Faculty of Sport Ljubljana
Slovenia Handball Clubs Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (1)

Drole K, Paravlic A, Steffen K, Doupona M. Effects of physical, psychosocial and dual-career loads on injuries and illnesses among elite handball players: protocol of prospective cohort study. BMJ Open. 2023 Mar 2;13(3):e069104. doi: 10.1136/bmjopen-2022-069104. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Body composition Body composition measurements with bio-impedance 12 months
Primary The Oslo Sports Trauma Research Center Questionnaire on Health Problems (OSTRC) Injury and illness questionnaire 12 months
Primary Load PHYSICAL, PSYCHOSOCIAL AND DUAL-CAREER loads 12 months
Secondary Biomarkers testosterone, cortisol, Immunoglobulin A (IgA) 12 months
Secondary Life Events Survey for Collegiate Athletes (LESCA) questionnaire Life Events Survey for Collegiate Athletes questionnaire 12 months
See also
  Status Clinical Trial Phase
Completed NCT03285009 - Movement Patterns in Young Volleyball Athletes N/A
Recruiting NCT05487768 - Functional Connectivity After Anterior Cruciate Ligament Reconstruction N/A
Not yet recruiting NCT06195631 - Evaluating a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy N/A
Completed NCT02329340 - Safety Skills Training: Parents of School-Aged Children Phase 2
Not yet recruiting NCT05529017 - Post Injury Performance Deficits in Rink Hockey
Recruiting NCT05910515 - Improving Performance in Pediatric Trauma by Teaching Nontechnical Skills N/A
Completed NCT04096196 - A Game-based Educational Approach to Promote Child Safety Knowledge and Behaviours N/A
Completed NCT06264323 - Incidence of Acute Injuries in Boxing
Completed NCT06039358 - Effects of Caffeine Ingestion on the Biomechanics of Healthy Young Subjects N/A
Recruiting NCT05394363 - Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents
Recruiting NCT06092866 - Digital Versus Telephone Symptom Assessment and Triage in Primary Care N/A
Not yet recruiting NCT05549830 - Effect of Different Positioning Before, During and After Surgery on Pressure Injury N/A
Active, not recruiting NCT00852085 - Reducing Youthful Dangerous Driving Phase 1/Phase 2
Completed NCT05552430 - Virtual Reality for Pain in Acute Orthopedic Injuries N/A
Not yet recruiting NCT06302088 - The Safety Integration Stakeholders (SAINTS) Program to Integrate Worker and Patient Safety in Oregon Rural Hospitals N/A
Recruiting NCT03517475 - Tailoring a Home Supervision Intervention for Low-Income Families N/A
Completed NCT03108820 - Trauma Medical Home for Older Injured Patients N/A
Active, not recruiting NCT05629156 - Injury and Illness Surveillance at the FIFA World Cup Qatar 2022TM
Completed NCT05121649 - Video-instructed First Aid in Emergency Medical Call Centers
Active, not recruiting NCT04469036 - Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center N/A

External Links