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Improvement of Physical Activity and Correction of Body Mass Index in School Children

Primary Purpose

Overweight

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
physical exercise
Sponsored by
University of Leipzig
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Physical fitness

Eligibility Criteria

9 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: School class Exclusion Criteria: Condition precluding exercise

Sites / Locations

  • University of Leipzig

Outcomes

Primary Outcome Measures

Improvement of maximal oxygen uptake

Secondary Outcome Measures

Change in body mass index

Full Information

First Posted
September 13, 2005
Last Updated
June 27, 2018
Sponsor
University of Leipzig
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1. Study Identification

Unique Protocol Identification Number
NCT00176371
Brief Title
Improvement of Physical Activity and Correction of Body Mass Index in School Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Withdrawn
Why Stopped
Head of the study has left the institution. Study never started.
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Leipzig

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Physical fitness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
physical exercise
Primary Outcome Measure Information:
Title
Improvement of maximal oxygen uptake
Secondary Outcome Measure Information:
Title
Change in body mass index

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: School class Exclusion Criteria: Condition precluding exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Schuler, Professor
Organizational Affiliation
University of Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leipzig
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04299
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22068444
Citation
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.
Results Reference
derived
PubMed Identifier
19920000
Citation
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.
Results Reference
derived

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Improvement of Physical Activity and Correction of Body Mass Index in School Children

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