Clinical trial NCT03286725: Physical Exercise for Education ('Fit to Study')
Official title: Physical Exercise for Education ('Fit to Study')
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Mental Health Wellness 1
Cognitive Function 1, Social
Academic Attainment
Fitness Testing
Lead sponsor: Oxford Brookes University
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2017-09-18
Enrollment: 20000
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief summary: Neuroscience evidence suggests that physical exercise can influence brain function and structure, both immediately and in the long-term. The 'Fit to Study' project is a randomised controlled trial to test the effects on academic performance (as well as fitness, wellbeing and cognitive function) of a teacher-training intervention designed to optimise the content of PE for brain and cognitive function during secondary school (Year 8) Physical Education (PE) lessons. The project aims to rigorously test the impact of this intervention in 100 state-funded secondary schools.

Detailed description: Physical exercise has been shown to have positive effects on the brain and to improve cognitive performance, both immediately and in the long-term. This project is being conducted to understand better how the content of school PE, focusing on Year8 pupils during the academic year 2017/18, affects brain function and structure, and academic performance.

A programme of activities for PE lessons has been developed by Oxford Brookes University (in collaboration with Oxfordshire Sport and Physical Activity) to try to optimise the benefit of PE for brain function. Staff from Oxford Brookes University will train PE teachers to deliver this programme.

'Fit to Study' is aiming to recruit 100 state-funded secondary schools from within a radius of Oxford.

The National Foundation for Education Research will help with recruitment by sending materials to target schools, collating responses, collecting pupil information from schools that sign up, and passing information to the research teams and NatCen Social Research (who will be responsible for randomisation). Participating schools will be randomly assigned to either an Intervention Group (IG) and be asked to deliver the new PE programme, or to a Control Group (CG) and asked to continue with their normal PE lessons. Randomisation will be achieved using a random sequence generated using Stata12. Balance between treatment and control groups will be achieved across a range of covariates (i.e. to ensure not all girls schools are assigned to one condition).

For both Groups there will be a number of activities for schools to undertake, both at the start, during, and at the end of the study. The key tasks are listed, and then described, below:

* Online Cognitive Tests (pre- and post-study)
* Wellbeing Questionnaires (pre- and post-study)
* Physical Activity Assessments (before and during the study)
* PE Teacher Training for Intervention Schools
* Fitness (Beep) Tests (pre- and post-study)
* NatCen will undertake an Independent Evaluation of the 'Fit to Study' programme.

In all schools, the pupils in the target year group will undergo baseline assessments (in the final term of Year 7), which will comprise tests of physical fitness; cognitive assessments; and questionnaires (about physical activity, sleep patterns, mood, motivation and wellbeing). The tests of physical fitness will be administered during PE lessons and will involve measures of speed and endurance. The school PE teachers will be involved in the administration of these tests. The cognitive tests (which will include tests of memory, executive functions and attention using button responses), and some of the questionnaires, will be computer-based and may be administered over the web, at school or at home, using a well-established online testing package.

PE teachers in the intervention condition schools will be trained to administer our intervention. Our training package will comprise a set of focused lesson principles and techniques for their delivery.

To foster friendly competition between schools, the investigators may produce newsletters/bulletins containing school league tables indicating summary physical activity levels during PE and/or proportion of assessments completed, but these will never contain individual pupils' data.

The investigators will use activity monitors to compare physical activity during intervention and control PE lessons. At the end of the intervention period (which is intended to be an academic year), the Year 8 pupils in all schools will repeat the assessments.

In addition, the University of Oxford will be conducting a sub-study with a small number of pupils from a subset of schools. This is an optional part of the project and will be subject to separate written / informed consent from the pupils' parents/guardians. This will involve MRI brain scanning at the University of Oxford, as well as additional fitness and cognitive tests. Further detail will be made available to schools that are selected to take part in the Main Study (from May 2017).

Eligibility criteria: Inclusion Criteria:

Inclusion is by school year group - typically aged 11-14:

* Year 7 pupils during the academic year 2016/17 (Age 11-12, KS3).
* Year 8 pupils during the academic year 2017/18 (Age 12-13, KS3).

Exclusion Criteria:

* Any pupils that are exempted from PE.
* Pupils that have 'opted out' of data sharing / storage for research purposes

Primary outcomes:
measure: Mathematical attainment: as measured using the level 13 Progress in Maths test (provided at GL assessment) at the end of the school year (June 2018).
timeFrame: 1 hour: Last month of the study (June 2018).
Secondary outcomes:
measure: Wellbeing Survey
timeFrame: 30 minutes: Baseline (June 2017) and final month of the study (June 2018)
measure: Cognitive Test of Attention and Reaction Time
timeFrame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
measure: Cognitive Test of Memory (Image Associates)
timeFrame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
measure: Eriksen Flanker Test
timeFrame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
measure: Cognitive Test of Memory (Two-back Image Task)
timeFrame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
measure: Cognitive Test of Executive Function
timeFrame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
measure: Fitness Assessment (20m Beep Test)
timeFrame: 20 minutes: Baseline (June 2017) and final month of the study (June 2018)
measure: Physical Activity Measurements
timeFrame: 60 minutes: Baseline (June 2017), at 14 weeks, at 28 weeks and final month of the study (June 2018).
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Brookes University
state: Oxfordshire
Study officials:
affiliation: Oxford Brookes University
name: Helen Dawes
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wassenaar TM, Wheatley CM, Beale N, Nichols T, Salvan P, Meaney A, Atherton K, Diaz-Ordaz K, Dawes H, Johansen-Berg H. The effect of a one-year vigorous physical activity intervention on fitness, cognitive performance and mental health in young adolescents: the Fit to Study cluster randomised controlled trial. Int J Behav Nutr Phys Act. 2021 Mar 31;18(1):47. doi: 10.1186/s12966-021-01113-y.
citation: Beale N, Eldridge E, Delextrat A, Esser P, Bushnell O, Curtis E, Wassenaar T, Wheatley C, Johansen-Berg H, Dawes H. Exploring activity levels in physical education lessons in the UK: a cross-sectional examination of activity types and fitness levels. BMJ Open Sport Exerc Med. 2021 Mar 9;7(1):e000924. doi: 10.1136/bmjsem-2020-000924. eCollection 2021.
citation: Wassenaar TM, Wheatley CM, Beale N, Salvan P, Meaney A, Possee JB, Atherton KE, Duda JL, Dawes H, Johansen-Berg H. Effects of a programme of vigorous physical activity during secondary school physical education on academic performance, fitness, cognition, mental health and the brain of adolescents (Fit to Study): study protocol for a cluster-randomised trial. Trials. 2019 Apr 2;20(1):189. doi: 10.1186/s13063-019-3279-6.