Body CompositionNCT02000492
Frequent Ballgames Training for 9-11 Year Old Schoolchildren
A study testing Football, Running and Circuit training in people with Body Composition and Echocardiography, run by University of Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 9 to 11 years
- Conditions the study is for
- Body Composition, Echocardiography
- What is being tested?
- Football, Running and Circuit training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 423 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 9-11 years old girls and boys in 3rd grade in schools in Frederikssund and Copenhagen
Who cannot join
- Children with severe mental or physical disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Body Composition, Echocardiography
- Being tested
- Football, Running, Circuit training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FootballBehavioural
RunningBehavioural
Circuit trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Football, circuit training or running 5x12 minutes or 3x 40 minutes Receives: Behavioral: Football; Behavioral: Running; Behavioral: Circuit training |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac function
echocardiography
Measured: 1 year
Body composition
dual energy x-ray absorptiometry (DXA-scanning)
Measured: 1 year
Secondary outcomes (1)
Cognitive effect
computer based tests for cognitive and learning effects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Responsible party
- Principal investigator, Claus Malta Nielsen, University of Copenhagen
- Investigators
- Peter Krustrup, Professor, Principal investigator, Centre of team sports and health, University of CopenhagenPeter R Hansen, dr Msc, Principal investigator, University hospital og Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000492
- Sponsor's protocol ID
- H-3-2013-038
- Other IDs
- 18172
- Status last verified
- Oct 2016
- First submitted
- 26 Nov 2013
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32497586Larsen 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.
PubMed 27297443
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intense School Based Physical Activity - Physiological, Cognitive and Sociological Aspects
- ClinicalTrials.gov ID
- NCT02000492
- Acronym / sponsor ID
- H-3-2013-038
- Conditions
- Body Composition, Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Study start
- Sep 2013
- Primary completion
- Jun 2016 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: Football, Behavioral: Running, Behavioral: Circuit trainingFootball, circuit training or running 5x12 minutes or 3x 40 minutes |
| Control | No intervention | – |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 9-11 years old girls and boys in 3rd grade in schools in Frederikssund and Copenhagen
Key exclusion criteria (1 listed)
- Children with severe mental or physical disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Football | Behavioural | Training |
| Running | Behavioural | Training |
| Circuit training | Behavioural | Training |
Primary outcome
Cardiac function
Time frame: 1 year
echocardiography
Body composition
Time frame: 1 year
dual energy x-ray absorptiometry (DXA-scanning)
1 secondary outcome
Cognitive effect
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 32497586Larsen 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.
- Derived from this study: PubMed 27297443Larsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Krustrup, Professor principal investigator
Centre of team sports and health, University of Copenhagen
Peter R Hansen, dr Msc principal investigator
University hospital og Gentofte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Football, Running and Circuit training in people with Body Composition and Echocardiography, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac function (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02000492, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.