Cognitive FunctionLCoMotionNCT02012881
LCoMotion. Learning, Cognition and Motion. Effect of a Four Month School-based Cluster-randomized Intervention
A study testing Physical activity intervention and Usual practice in people with Cognitive Function, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the effect of a four months school-based physical activity intervention on cognition, academic achievement, physical activity and aerobic fitness in 12-15 year old adolescents. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- Physical activity intervention and Usual practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 870 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Jun 2014
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- six or seventh grader in a Danish public school
- participating in normal math lessons
Who cannot join
- private school
- receiving extra math lessons because of special needs
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Science and Clinical Biomechanics
Odense, 5230
About this study
The purpose of this study is to determine the effect of a four months school-based physical activity intervention on cognition, academic achievement, physical activity and aerobic fitness in 12-15 year old adolescents.
- Conditions
- Cognitive Function
- Being tested
- Physical activity intervention, Usual practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
Physical activity during recess, in academic subjects, active transportation and PA home work
Usual practiceBehavioural
Normal curriculum
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | 60 minutes of physical activity on every school day Receives: Behavioral: Physical activity intervention |
| Control | Active comparator | Usual practice Receives: Behavioral: Usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive function accuracy
Executive function (part of cognitive function) measured by a modified computer-based flanker-test
Measured: Up to 8 months
Secondary outcomes (5)
Academic achievement
A standardized math test
Measured: November 2013 -June 2014
Physical activity
Measured with accelerometers for one week both pre- and post-intervention and supplemented with a questionnaire
Measured: November 2013-June 2014
Aerobic fitness
Measured with an intermittent running test (Andersen test)
Measured: November 2013 - June 2014
Anthropometric measures
Body height, body weight, waist circumference and puberty status (self-assessed)
Measured: November 2013 - June 2014
Questionnaire
To students and parents. SES, family diseases, physical activity, sport participation
Measured: November 2013 - June 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionJun 2014
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 Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 870 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Denmark
- Responsible party
- Principal investigator, Anna Bugge, Post Doc, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012881
- Sponsor's protocol ID
- S-20130104
- Acronym
- LCoMotion
- Status last verified
- Jun 2014
- First submitted
- 11 Oct 2013
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Tarp J, Domazet SL, Froberg K, Hillman CH, Andersen LB, Bugge A. Effectiveness of a School-Based Physical Activity Intervention on Cognitive Performance in Danish Adolescents: LCoMotion-Learning, Cognition and Motion - A Cluster Randomized Controlled Trial. PLoS One. 2016 Jun 24;11(6):e0158087. doi: 10.1371/journal.pone.0158087. eCollection 2016.
PubMed 27341346Bugge A, Tarp J, Ostergaard L, Domazet SL, Andersen LB, Froberg K. LCoMotion - Learning, Cognition and Motion; a multicomponent cluster randomized school-based intervention aimed at increasing learning and cognition - rationale, design and methods. BMC Public Health. 2014 Sep 18;14:967. doi: 10.1186/1471-2458-14-967.
PubMed 25236478
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCoMotion. Learning, Cognition and Motion. Effect of a Four Month School-based Cluster-randomized Intervention
- ClinicalTrials.gov ID
- NCT02012881
- Acronym / sponsor ID
- LCoMotion / S-20130104
- Conditions
- Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 870 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Ministry of Education, Denmark
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 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.
The purpose of this study is to determine the effect of a four months school-based physical activity intervention on cognition, academic achievement, physical activity and aerobic fitness in 12-15 year old adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Experimental | Behavioral: Physical activity intervention60 minutes of physical activity on every school day |
| Control | Active comparator | Behavioral: Usual practiceUsual practice |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- six or seventh grader in a Danish public school
- participating in normal math lessons
Key exclusion criteria (2 listed)
- private school
- receiving extra math lessons because of special needs
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 |
|---|---|---|
| Physical activity interventionPhysical activity during recess, in academic subjects, active transportation and PA home work | Behavioural | Physical activity intervention |
| Usual practiceNormal curriculum | Behavioural | Control |
Primary outcome
Executive function accuracy
Time frame: Up to 8 months
Executive function (part of cognitive function) measured by a modified computer-based flanker-test
5 secondary outcomes
Academic achievement
Time frame: November 2013 -June 2014
Physical activity
Time frame: November 2013-June 2014
Aerobic fitness
Time frame: November 2013 - June 2014
Anthropometric measures
Time frame: November 2013 - June 2014
Questionnaire
Time frame: November 2013 - June 2014
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 Jun 2014.
- Derived from this study: PubMed 27341346Tarp J, Domazet SL, Froberg K, Hillman CH, Andersen LB, Bugge A. Effectiveness of a School-Based Physical Activity Intervention on Cognitive Performance in Danish Adolescents: LCoMotion-Learning, Cognition and Motion - A Cluster Randomized Controlled Trial. PLoS One. 2016 Jun 24;11(6):e0158087. doi: 10.1371/journal.pone.0158087. eCollection 2016.
- Derived from this study: PubMed 25236478Bugge A, Tarp J, Ostergaard L, Domazet SL, Andersen LB, Froberg K. LCoMotion - Learning, Cognition and Motion; a multicomponent cluster randomized school-based intervention aimed at increasing learning and cognition - rationale, design and methods. BMC Public Health. 2014 Sep 18;14:967. doi: 10.1186/1471-2458-14-967.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention and Usual practice in people with Cognitive Function, run by University of Southern Denmark 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 2 inclusion and 2 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 Jun 2014. 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?
Executive function accuracy (time frame: Up to 8 months). 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 NCT02012881, 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 Jun 2014.