- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00176371
Improvement of Physical Activity and Correction of Body Mass Index in School Children
There is an increasing incidence of overweight children in Germany, due to a lack of physical activity.
The aim of this study is to improve physical fitness and activity in school children. Two classes in different schools are provided with additional sport lessons over a period of one year.
Study Overview
Detailed Description
The increasing incidence of overweight children in Germany is due to a lack of physical activity and intake of unhealthy food. The importance of physical activity for the prevention of cardiovascular diseases in adults was shown in several trials. Therefore we provide additional sport lessons over the period of one year in two defined schools in Leipzig with the aim to improve physical fitness in school children. Two other classes with the -in germany- usual quantity of sport classes served as control classes.
In all classes at the beginning and at the end of the school year blood samples were taken, and a clinical investigation, a coordination test for children and a spiroergometer were performed. Additionally each child had to fill out a questionnaire.
Endurance training is emphasized in the sport lessons.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Saxony
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Leipzig, Saxony, Germany, 04299
- University of Leipzig
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- School class
Exclusion Criteria:
- Condition precluding exercise
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Improvement of maximal oxygen uptake
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Secondary Outcome Measures
Outcome Measure |
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Change in body mass index
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gerhard Schuler, Professor, University of Leipzig
Publications and helpful links
General Publications
- Walther C, Mende M, Gaede L, Muller U, Machalica K, Schuler G. [Effects of daily physical exercise at school on cardiovascular risk--results of a 2-year cluster-randomized study]. Dtsch Med Wochenschr. 2011 Nov;136(46):2348-54. doi: 10.1055/s-0031-1292049. Epub 2011 Nov 8. German.
- Walther C, Gaede L, Adams V, Gelbrich G, Leichtle A, Erbs S, Sonnabend M, Fikenzer K, Korner A, Kiess W, Bruegel M, Thiery J, Schuler G. Effect of increased exercise in school children on physical fitness and endothelial progenitor cells: a prospective randomized trial. Circulation. 2009 Dec 1;120(22):2251-9. doi: 10.1161/CIRCULATIONAHA.109.865808. Epub 2009 Nov 17.
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- school project
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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