|- candidate number||22525|
|- NTR Number||NTR5341|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-jul-2015|
|- Secondary IDs||NRO: 405-15-410 |
|- Public Title||Learning by moving|
|- Scientific Title||Effects of physical activity on academic achievement in primary school children: A cluster randomized controlled trial (RCT)|
|- hypothesis||In this RCT we investigate the effects of two school-based physical activity interventions (aerobic exercises versus coordinative exercises) in primary school children on executive functions and academic achievement. We hypothesize that both aerobic and coordinative exercises benefit executive functions and academic achievement.|
|- Healt Condition(s) or Problem(s) studied||Physical activity, Cognition, Children|
|- Inclusion criteria||Dutch preadolescent children between the 7 and 12 years of age attending regular primary schools.|
|- Exclusion criteria||Children with cardiovascular diseases or physical disabilities which prevent them from participating regular physical education lessons.|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2015|
|- planned closingdate||17-apr-2018|
|- Target number of participants||1200|
|- Interventions||Both programs will take place during regular school hours (during regular and extra physical education hours). The duration of the intervention will be 14 weeks, four times a week with 30 minutes for each training session.
Aerobic exercise intervention: The aerobic exercises involve short tasks and games requiring different forms of running.
Complex coordinative exercise intervention: The exercises involve a high amount of mental engagement and are specifically tailored to challenge executive functions. the exercises are performed.|
Control group: the control group will recieve regular physical education lessons.
|- Primary outcome||- Academic performance, measured using items of the child academic monitoring system (CITO).|
|- Secondary outcome||- Executive functions, measured using computerized instruments assessing different domains.|
- Physical fitness, measured using items from the Eurofit test battery.
- Motor proficiency, measured using items from the Bruininks-Oseretsky Test (second edition) of motor proficiency.
|- Timepoints||Assessment of the intervention groups and control group will take place at baseline (T0) and after the intervention (T1). |
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| J.W. de Greeff|
|- CONTACT for SCIENTIFIC QUERIES|| J.W. de Greeff|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), VU University Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief summary||The aim of the current study is to examine effects of two school-based physical activity interventions in primary school children on executive functions, and academic achievement. Participating schools will be randomly assigned to an aerobic intervention, a complex coordinative exercise intervention or control condition. The RCT will demonstrate effects of different types of interventions (aerobic exercises versus coordinative exercises) on academic achievement and a possible mediating role of executive functioning. In addition, our RCT provides insight into feasibility of implementation in the Dutch primary school setting.|
|- Main changes (audit trail)|
|- RECORD||31-jul-2015 - 24-aug-2015|