NCT05471297

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 17, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

July 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

11 months

First QC Date

July 17, 2022

Last Update Submit

November 14, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

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

    Injury and illness questionnaire

    12 months

  • Load

    PHYSICAL, PSYCHOSOCIAL AND DUAL-CAREER loads

    12 months

Secondary Outcomes (2)

  • Biomarkers

    12 months

  • Life Events Survey for Collegiate Athletes (LESCA) questionnaire

    12 months

Other Outcomes (1)

  • Body composition

    12 months

Study Arms (1)

Handball players

Professional handball players

Other: There is no intervention

Interventions

There is no any intervention

Handball players

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The first league handball players

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Sport

Ljubljana, Slovenia, 1000, Slovenia

Location

Handball Clubs

Ljubljana, 1000, Slovenia

Location

Related Publications (3)

  • 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.

    PMID: 36863744BACKGROUND
  • Drole K, Busch A, Paravlic A, Doupona M, Steffen K. Prevalence, incidence and burden of health problems across playing positions in elite male handball players: a 45-week prospective cohort study. BMJ Open Sport Exerc Med. 2025 Apr 5;11(2):e002460. doi: 10.1136/bmjsem-2025-002460. eCollection 2025.

  • Drole K, Steffen K, Paravlic A. Slovenian Translation, Cross-Cultural Adaptation, and Content Validation of the Updated Oslo Sports Trauma Research Center Questionnaire on Health Problems (OSTRC-H2). Orthop J Sports Med. 2024 Nov 13;12(11):23259671241287767. doi: 10.1177/23259671241287767. eCollection 2024 Nov.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be taken to investigate the levels of testosterone, cortisol and IgA hormones during a single competitive season

MeSH Terms

Conditions

Wounds and InjuriesChronic DiseaseOccupational DiseasesAthletic Injuries

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kristina Drole, MSc

    Faculty of Sport, University of Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Supervisor

Study Record Dates

First Submitted

July 17, 2022

First Posted

July 22, 2022

Study Start

July 20, 2022

Primary Completion

June 4, 2023

Study Completion

September 1, 2023

Last Updated

November 18, 2024

Record last verified: 2024-11

Locations