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Physical Exercise for Education ('Fit to Study') (FTS)

18 de abril de 2022 atualizado por: Helen Dawes, Oxford Brookes University
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.

Visão geral do estudo

Descrição detalhada

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).

Tipo de estudo

Intervencional

Inscrição (Real)

20000

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Oxfordshire
      • Oxford, Oxfordshire, Reino Unido, OX3 0BP
        • Oxford Brookes University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

11 anos a 14 anos (Filho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Control Group
The Control Group will be asked to continue with their normal PE lessons.
Experimental: Intervention Group
'Physical Education (PE) Programme'

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.

The Intervention involves roughly 20 minutes of prescribed activities per week, to be delivered within school PE lessons.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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).
Prazo: 1 hour: Last month of the study (June 2018).

The Primary Outcome Measure is recorded on the ISRCTN registry with study ID ISRCTN15730512.

Mathematical attainment as measured using the level 13 Progress in Maths test (provided at GL assessment) at the end of the school year.

1 hour: Last month of the study (June 2018).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Wellbeing Survey
Prazo: 30 minutes: Baseline (June 2017) and final month of the study (June 2018)
A battery of surveys each including a number of measures: adolescent mental health and wellbeing; daytime sleepiness; physical and global self-esteem; PE enjoyment; single measures of health-related quality of life and weekly moderate to vigorous physical activity (MVPA); attitudes, social norms, competence, intentions and willingness in relation to physical activity. Approximately 60 questions in total, taking 30 minutes to complete.
30 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Attention and Reaction Time
Prazo: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
This is one of five (computer-based) cognitive tasks developed via jsPsych that are completed by participants at one sitting. It is an attention/ reaction-time task, to appearance of red triangles on the screen.
10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Memory (Image Associates)
Prazo: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
This is one of five (computer-based) cognitive tasks developed via jsPsych that are completed by participants at one sitting. It is an (image) association of place, person and object (memory) task.
10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Eriksen Flanker Test
Prazo: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
This is one of five (computer-based) cognitive tasks developed via jsPsych that are completed by participants at one sitting. It is a (modified) Eriksen Flanker task.
10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Memory (Two-back Image Task)
Prazo: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
This is one of five (computer-based) cognitive tasks developed via jsPsych that are completed by participants at one sitting. It is a two-back image (memory) task (saying whether a picture is the same as the one before last).
10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Executive Function
Prazo: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
This is one of five (computer-based) cognitive tasks developed via jsPsych that are completed by participants at one sitting. It is a task-switching (executive function) task (arms up or arms down characters in relation to shape or colour questions).
10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Fitness Assessment (20m Beep Test)
Prazo: 20 minutes: Baseline (June 2017) and final month of the study (June 2018)
A distance of 20m is measured; cones are placed at lines indicating the distance. Pupils stand behind one of the lines facing the 2nd line, and begin running when instructed by an audio recording. The pupils continue running between the two lines, turning when signalled by the recorded beeps. After one minute, a sound indicates an increase in speed, and the beeps will be closer together. This continues each minute (level). If the line is reached before the beep sounds, the subject must wait until the beep sounds before continuing. If the line is not reached before the beep sounds, the subject is given a warning and must continue to run to the line, then turn and try to catch up with the pace within two more 'beeps'. The test is stopped if the subject fails to reach the line (within 2m) for two consecutive ends after a warning. Participants are instructed to remember the last number that was called before they stopped and tell the teacher who is recording the scores.
20 minutes: Baseline (June 2017) and final month of the study (June 2018)
Physical Activity Measurements
Prazo: 60 minutes: Baseline (June 2017), at 14 weeks, at 28 weeks and final month of the study (June 2018).
All pupils will be provided with wrist-worn Axivity AX3 accelerometers, to be worn on the non-dominant wrist, to record their physical activity (PA) during a PE lesson. The AX3 is a tri-axial accelerometer which measures linear acceleration from +/- 2g to +/- 16g range along three orthogonal axes known as 'z' (upward and downward), 'y' (left and right) and 'x' (forward and backward).
60 minutes: Baseline (June 2017), at 14 weeks, at 28 weeks and final month of the study (June 2018).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Colaboradores

Investigadores

  • Investigador principal: Helen Dawes, Oxford Brookes University

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de maio de 2017

Conclusão Primária (Real)

1 de julho de 2019

Conclusão do estudo (Real)

1 de julho de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

16 de agosto de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de setembro de 2017

Primeira postagem (Real)

18 de setembro de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de abril de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de abril de 2022

Última verificação

1 de abril de 2022

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • EEF2681 (Education Endowment Foundation)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

On conclusion of the project, the Fischer Family Trust (see http://www.fft.org.uk/) will collate and upload anonymised data to the UK Data Archive (for the primary outcome measure). This archived data (for the primary outcome measure) will only be available in an anonymised form with restricted access for research purposes only.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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