InjuriesPPDC-2022NCT05471297
Loads, Injuries and Illnesses Among Elite Handball Players
An observational study of Injuries and Illnesses Systemic, run by University of Ljubljana at 2 sites in Slovenia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Injuries, Illnesses Systemic, Illness, Chronic
- How many people
- 189 participants
- Where
- 2 sitesSlovenia
- Study dates
- 20 Jul 2022to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The first league handball players
Who may be able to join
- 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.
Who cannot join
- Not fulfilling inclusion critieria
Trial locations and contacts
2 sites in 1 country.
Slovenia2 sites
Faculty of Sport
Ljubljana, Slovenia, 1000
Handball Clubs
Ljubljana, 1000
About this study
Official title: Effects of Physical, Psychosocial and Dual-career Loads on Injuries and Illnesses Among Elite Handball Players
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.
- Conditions
- Injuries, Illnesses Systemic, Illness, Chronic, Illnesses, Occupational, Psychological, Physical Illness
- Being tested
- There is no intervention
- Medical subject headings
- Wounds and Injuries, Chronic Disease, Occupational Diseases, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no interventionOther
There is no any intervention
| Study group | Role | What they receive |
|---|---|---|
| Handball players | Professional handball players Receives: Other: There is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Oslo Sports Trauma Research Center Questionnaire on Health Problems (OSTRC)
Injury and illness questionnaire
Measured: 12 months
Load
PHYSICAL, PSYCHOSOCIAL AND DUAL-CAREER loads
Measured: 12 months
Secondary outcomes (2)
Biomarkers
testosterone, cortisol, Immunoglobulin A (IgA)
Measured: 12 months
Life Events Survey for Collegiate Athletes (LESCA) questionnaire
Life Events Survey for Collegiate Athletes questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start20 Jul 2022
- Primary completion4 Jun 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin Paravlic, University of Ljubljana
- Investigators
- Kristina Drole, MSc, Principal investigator, Faculty of Sport, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471297
- Sponsor's protocol ID
- PPDC-2022
- Acronym
- PPDC-2022
- Status last verified
- Nov 2024
- First submitted
- 17 Jul 2022
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available upon the reasonable request to principal investigator
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 36863744Drole 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.
PubMed 40195973Drole 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.
PubMed 39539687
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical, Psychosocial and Dual-career Loads on Injuries and Illnesses Among Elite Handball Players
- ClinicalTrials.gov ID
- NCT05471297
- Acronym / sponsor ID
- PPDC-2022 / PPDC-2022
- Conditions
- Injuries, Illnesses Systemic, Illness, Chronic, Illnesses, Occupational, Psychological, Physical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 4 Jun 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Handball players | – | Other: There is no interventionProfessional handball players |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The first league handball players
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Not fulfilling inclusion critieria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no interventionThere is no any intervention | Other | Handball players |
Primary outcome
The Oslo Sports Trauma Research Center Questionnaire on Health Problems (OSTRC)
Time frame: 12 months
Injury and illness questionnaire
Load
Time frame: 12 months
PHYSICAL, PSYCHOSOCIAL AND DUAL-CAREER loads
2 secondary outcomes
Biomarkers
Time frame: 12 months
Life Events Survey for Collegiate Athletes (LESCA) questionnaire
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Background: PubMed 36863744Drole 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.
- Derived from this study: PubMed 40195973Drole 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.
- Derived from this study: PubMed 39539687Drole 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.
- Link to a study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data will be available upon the reasonable request to principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Drole, MSc principal investigator
Faculty of Sport, University of Ljubljana
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Injuries and Illnesses Systemic, run by University of Ljubljana at 2 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Oslo Sports Trauma Research Center Questionnaire on Health Problems (OSTRC) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05471297, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.