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NCT02000492 Clinical Trial

Frequent Ballgames Training for 9-11 Year Old Schoolchildren

Body Composition Clinical Trial

Official title:
Intense School Based Physical Activity - Physiological, Cognitive and Sociological Aspects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02000492
Other study ID # H-3-2013-038
Secondary ID 18172
Status Completed
Phase N/A
First received November 26, 2013
Last updated October 25, 2016
Start date September 2013

Study information
Verified date October 2016
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

Inactivity among schoolchildren is a challenge to public health and for the municipality in particular. This study´s aim is to evaluate the cognitive and physical as well as social and fitness adaptations, and learning outcomes of short- and long term ball training for 9-11 years old girls and boys, and to determine to what extend the organisation (5x12 minutes og 3x40 minute a week) and type of training (ball games, circuit training or running) influence the magnitude of response.

Recruitment information / eligibility
Status Completed
Enrollment 423
Est. completion date
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 9 Years to 11 Years
Eligibility Inclusion Criteria:

- 9-11 years old girls and boys in 3rd grade in schools in Frederikssund and Copenhagen

Exclusion Criteria:

- Children with severe mental or physical disabilities

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Behavioral:
• Football

• Running

• Circuit training

Locations
Country Name City State
Denmark Municipality of Frederikssund Frederikssund

Sponsors (2)
Lead Sponsor Collaborator
University of Copenhagen University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Other Social effects focus group Interviews 1 Year No
Primary Cardiac function echocardiography 1 year No
Primary Body composition dual energy x-ray absorptiometry (DXA-scanning) 1 year Yes
Secondary Cognitive effect computer based tests for cognitive and learning effects 1 year No
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