- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02000492
Frequent Ballgames Training for 9-11 Year Old Schoolchildren
October 25, 2016 updated by: Claus Malta Nielsen, University of Copenhagen
Intense School Based Physical Activity - Physiological, Cognitive and Sociological Aspects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
423
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Frederikssund, Denmark, 3600
- Municipality of Frederikssund
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Training
Football, circuit training or running 5x12 minutes or 3x 40 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac function
Time Frame: 1 year
|
echocardiography
|
1 year
|
Body composition
Time Frame: 1 year
|
dual energy x-ray absorptiometry (DXA-scanning)
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive effect
Time Frame: 1 year
|
computer based tests for cognitive and learning effects
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social effects
Time Frame: 1 Year
|
focus group Interviews
|
1 Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Krustrup, Professor, Centre of team sports and health, University of Copenhagen
- Principal Investigator: Peter R Hansen, dr Msc, University hospital og Gentofte
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Larsen MN, Madsen M, Nielsen CM, Manniche V, Hansen L, Bangsbo J, Krustrup P, Hansen PR. Cardiovascular adaptations after 10 months of daily 12-min bouts of intense school-based physical training for 8-10-year-old children. Prog Cardiovasc Dis. 2020 Nov-Dec;63(6):813-817. doi: 10.1016/j.pcad.2020.05.011. Epub 2020 Jun 1.
- Larsen MN, Nielsen CM, Helge EW, Madsen M, Manniche V, Hansen L, Hansen PR, Bangsbo J, Krustrup P. Positive effects on bone mineralisation and muscular fitness after 10 months of intense school-based physical training for children aged 8-10 years: the FIT FIRST randomised controlled trial. Br J Sports Med. 2018 Feb;52(4):254-260. doi: 10.1136/bjsports-2016-096219. Epub 2016 Jun 13.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
November 26, 2013
First Submitted That Met QC Criteria
November 26, 2013
First Posted (Estimate)
December 4, 2013
Study Record Updates
Last Update Posted (Estimate)
October 26, 2016
Last Update Submitted That Met QC Criteria
October 25, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- H-3-2013-038
- 18172 (Other Identifier: Styrelsen for Forskning og Innovation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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