NCT00176371

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

June 29, 2018

Status Verified

September 1, 2006

First QC Date

September 13, 2005

Last Update Submit

June 27, 2018

Conditions

Overweight

Keywords

Physical fitness

Outcome Measures

Primary Outcomes (1)

  • Improvement of maximal oxygen uptake

Secondary Outcomes (1)

  • Change in body mass index

Interventions

physical exerciseBEHAVIORAL

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • School class

You may not qualify if:

  • Condition precluding exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig

Leipzig, Saxony, 04299, Germany

Location

Related Publications (2)

  • 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.

    PMID: 22068444DERIVED

  • 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.

    PMID: 19920000DERIVED

MeSH Terms

Conditions

Overweight

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gerhard Schuler, Professor

    University of Leipzig

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

July 1, 2005

Study Completion

December 1, 2006

Last Updated

June 29, 2018

Record last verified: 2006-09

Locations

DE(1)