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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00946855
Other study ID # Soccer laboratory values
Secondary ID
Status Completed
Phase N/A
First received July 24, 2009
Last updated July 24, 2009
Start date August 2008
Est. completion date July 2009

Study information

Verified date July 2009
Source Saarland University
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 467
Est. completion date July 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- being employed as player by a club of the first two German soccer leagues

- healthy

Exclusion Criteria:

- chronic disease interfering with one or more of the determined parameters

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Institute of Sports and Preventive Medicine, University of Saarland, Campus, Bldg. B 8-2, Saarbrücken Saarland

Sponsors (1)

Lead Sponsor Collaborator
Saarland University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary complete blood count August 2008 until May 2009 No
Secondary numerous serum parameters from venous blood August 2008 until May 2009 No
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