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CompletedNCT05471297PPDC-2022Updated Nov 18, 2024

Loads, Injuries and Illnesses Among Elite Handball Players

An observational study in Injuries, Illnesses Systemic and Illness, Chronic, sponsored by University of Ljubljana. Completed at 2 sites in Slovenia. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.

Sponsored by University of Ljubljana · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
189
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Injuries
  • Illnesses Systemic
  • Illness, Chronic
  • Illnesses, Occupational
  • Psychological
  • Physical Illness
  • Physical Stress
  • Physical Injury
  • Physical Trauma
  • Social Stress
  • Athletic Injuries
03

In context

Chronic Disease

990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.

This study's enrollment of 189 is below the median of 419 across 249 observational studies indexed under Chronic Disease.

Browse Chronic Disease studies →

Lead sponsor

University of Ljubljana is the lead sponsor of 42 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The first league handball players

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

Exclusion Criteria:

  • Not fulfilling inclusion critieria
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
189 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Handball players

    Professional handball players

    Other: There is no intervention

Interventions

  • OtherThere is no intervention

    There is no any intervention

06

What researchers measure

Primary outcomes

  1. The Oslo Sports Trauma Research Center Questionnaire on Health Problems (OSTRC)

    Injury and illness questionnaire

    Time frame: 12 months

  2. Load

    PHYSICAL, PSYCHOSOCIAL AND DUAL-CAREER loads

    Time frame: 12 months

Secondary outcomes

  1. Biomarkers

    testosterone, cortisol, Immunoglobulin A (IgA)

    Time frame: 12 months

  2. Life Events Survey for Collegiate Athletes (LESCA) questionnaire

    Life Events Survey for Collegiate Athletes questionnaire

    Time frame: 12 months

Other outcomes

  1. Body composition

    Body composition measurements with bio-impedance

    Time frame: 12 months

07

Study locations

2 sites
  • Faculty of Sport
    Ljubljana, 1000, Slovenia
  • Handball Clubs
    Ljubljana, 1000, Slovenia
08

References and documents

Publications

  • 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. PubMed 36863744 ↗

Individual participant data

Plan to share: Undecided — Data will be available upon the reasonable request to principal investigator

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05471297
Lead sponsor
University of Ljubljana
Responsible party
Armin Paravlic (Supervisor, University of Ljubljana) — Principal investigator
First posted
Jul 22, 2022
Start date
Jul 20, 2022
Primary completion
Jun 4, 2023
Completion
Sep 1, 2023
Last update
Nov 18, 2024

Study contacts

Kristina Drole, MSc
principal investigator · Faculty of Sport, University of Ljubljana

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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