StressSOCCERLABNCT00946855
Effect of Elite Soccer Training on Routine Laboratory Parameters
An observational study of Stress, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
Repeated blood sampling within a regular soccer season of German first league clubs shall serve to define soccer-specific reference values for routine parameters determined from venous blood. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stress
- How many people
- 467 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2008to Jul 2009
- 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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: soccer players of the first two German professional soccer leagues
Who may be able to join
- being employed as player by a club of the first two German soccer leagues
- healthy
Who cannot join
- chronic disease interfering with one or more of the determined parameters
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Sports and Preventive Medicine, University of Saarland, Campus, Bldg. B 8-2,
Saarbrücken, Saarland, 66123
About this study
Official title: Laboratory Values in Elite Soccer Players
Repeated blood sampling within a regular soccer season of German first league clubs shall serve to define soccer-specific reference values for routine parameters determined from venous blood. It was hypothesized that only for a minor number of parameters common reference values will have to be adapted for soccer players during their competitive season.
Read the detailed description
It is often difficult to discern exercise-induced changes in laboratory parameters from pathological changes in elite athletes during the regular training process. This is particularly true in soccer players who compete more often than many other athletes. Therefore, soccer players of the first two German soccer leagues (all professional athletes) are recruited for repeated blood sampling during the season (4 sampling times, one of them immediately before training commences in the summer, the other ones in October/November, February/March, and April/May). Among other standardizing requirements, it is mandatory that precisely one training session (not zero, not two, no competition) takes place the day before sampling. Several confounders for the interpretation of laboratory results are verified by means of a questionnaire. Phases of high competitive stress are compared with those of low stress. The course of the parameters as well as confidence intervals for given times during the season are of main interest.
- Conditions
- Stress
- Keywords
- soccer, laboratory, reference, exercise, variability, season, elite athletes, Define reference blood parameters in elite athletes
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| soccer players | players of the first two German soccer leagues |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete blood count
Measured: August 2008 until May 2009
Secondary outcomes (1)
numerous serum parameters from venous blood
Measured: August 2008 until May 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startAug 2008
- Primary completionMay 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Investigators
- Tim Meyer, MD, PhD, Principal investigator, Institute of Sports and Preventive Medicine, University of Saarland, Campus, Bldg. B 8-2, 66123 Saarbrücken, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946855
- Sponsor's protocol ID
- Soccer laboratory values
- Acronym
- SOCCERLAB
- Status last verified
- Jul 2009
- First submitted
- 24 Jul 2009
- Last updated
- 27 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Breitbart P, Meister S, Meyer T, Gartner BC. Incidence and Prevalence of Borrelia burgdorferi Antibodies in Male Professional Football Players. Clin J Sport Med. 2021 Jul 1;31(4):e200-e206. doi: 10.1097/JSM.0000000000000758.
PubMed 31241490Meyer T, Meister S. Routine blood parameters in elite soccer players. Int J Sports Med. 2011 Nov;32(11):875-81. doi: 10.1055/s-0031-1280776. Epub 2011 Oct 21.
PubMed 22020850
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laboratory Values in Elite Soccer Players
- ClinicalTrials.gov ID
- NCT00946855
- Acronym / sponsor ID
- SOCCERLAB / Soccer laboratory values
- Conditions
- Stress
- Keywords
- soccer, laboratory, reference, exercise, variability, season, elite athletes, Define reference blood parameters in elite athletes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 27 Jul 2009 (estimated)
- 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.
Repeated blood sampling within a regular soccer season of German first league clubs shall serve to define soccer-specific reference values for routine parameters determined from venous blood. It was hypothesized that only for a minor number of parameters common reference values will have to be adapted for soccer players during their competitive season.
Detailed description
It is often difficult to discern exercise-induced changes in laboratory parameters from pathological changes in elite athletes during the regular training process. This is particularly true in soccer players who compete more often than many other athletes. Therefore, soccer players of the first two German soccer leagues (all professional athletes) are recruited for repeated blood sampling during the season (4 sampling times, one of them immediately before training commences in the summer, the other ones in October/November, February/March, and April/May). Among other standardizing requirements, it is mandatory that precisely one training session (not zero, not two, no competition) takes place the day before sampling. Several confounders for the interpretation of laboratory results are verified by means of a questionnaire. Phases of high competitive stress are compared with those of low stress. The course of the parameters as well as confidence intervals for given times during the season are of main interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| soccer players | – | –players of the first two German soccer leagues |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- soccer players of the first two German professional soccer leagues
Key inclusion criteria (2 listed)
- being employed as player by a club of the first two German soccer leagues
- healthy
Key exclusion criteria (1 listed)
- chronic disease interfering with one or more of the determined parameters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
complete blood count
Time frame: August 2008 until May 2009
1 secondary outcome
numerous serum parameters from venous blood
Time frame: August 2008 until May 2009
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 27 Jul 2009.
- Derived from this study: PubMed 31241490Breitbart P, Meister S, Meyer T, Gartner BC. Incidence and Prevalence of Borrelia burgdorferi Antibodies in Male Professional Football Players. Clin J Sport Med. 2021 Jul 1;31(4):e200-e206. doi: 10.1097/JSM.0000000000000758.
- Derived from this study: PubMed 22020850Meyer T, Meister S. Routine blood parameters in elite soccer players. Int J Sports Med. 2011 Nov;32(11):875-81. doi: 10.1055/s-0031-1280776. Epub 2011 Oct 21.
- Homepage of study centerLink provided by the sponsor.
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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.
Tim Meyer, MD, PhD principal investigator
Institute of Sports and Preventive Medicine, University of Saarland, Campus, Bldg. B 8-2, 66123 Saarbrücken, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, run by Universität des Saarlandes at 1 site in Germany.
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 27 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
complete blood count (time frame: August 2008 until May 2009). 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 NCT00946855, which also lists 2 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 27 Jul 2009.