<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03286725</url>
  </required_header>
  <id_info>
    <org_study_id>EEF2681</org_study_id>
    <nct_id>NCT03286725</nct_id>
  </id_info>
  <brief_title>Physical Exercise for Education ('Fit to Study')</brief_title>
  <acronym>FTS</acronym>
  <official_title>Physical Exercise for Education ('Fit to Study')</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oxford Brookes University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oxford Brookes University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neuroscience evidence suggests that physical exercise can influence brain function and&#xD;
      structure, both immediately and in the long-term. The 'Fit to Study' project is a randomised&#xD;
      controlled trial to test the effects on academic performance (as well as fitness, wellbeing&#xD;
      and cognitive function) of a teacher-training intervention designed to optimise the content&#xD;
      of PE for brain and cognitive function during secondary school (Year 8) Physical Education&#xD;
      (PE) lessons. The project aims to rigorously test the impact of this intervention in 100&#xD;
      state-funded secondary schools.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physical exercise has been shown to have positive effects on the brain and to improve&#xD;
      cognitive performance, both immediately and in the long-term. This project is being conducted&#xD;
      to understand better how the content of school PE, focusing on Year8 pupils during the&#xD;
      academic year 2017/18, affects brain function and structure, and academic performance.&#xD;
&#xD;
      A programme of activities for PE lessons has been developed by Oxford Brookes University (in&#xD;
      collaboration with Oxfordshire Sport and Physical Activity) to try to optimise the benefit of&#xD;
      PE for brain function. Staff from Oxford Brookes University will train PE teachers to deliver&#xD;
      this programme.&#xD;
&#xD;
      'Fit to Study' is aiming to recruit 100 state-funded secondary schools from within a radius&#xD;
      of Oxford.&#xD;
&#xD;
      The National Foundation for Education Research will help with recruitment by sending&#xD;
      materials to target schools, collating responses, collecting pupil information from schools&#xD;
      that sign up, and passing information to the research teams and NatCen Social Research (who&#xD;
      will be responsible for randomisation). Participating schools will be randomly assigned to&#xD;
      either an Intervention Group (IG) and be asked to deliver the new PE programme, or to a&#xD;
      Control Group (CG) and asked to continue with their normal PE lessons. Randomisation will be&#xD;
      achieved using a random sequence generated using Stata12. Balance between treatment and&#xD;
      control groups will be achieved across a range of covariates (i.e. to ensure not all girls&#xD;
      schools are assigned to one condition).&#xD;
&#xD;
      For both Groups there will be a number of activities for schools to undertake, both at the&#xD;
      start, during, and at the end of the study. The key tasks are listed, and then described,&#xD;
      below:&#xD;
&#xD;
        -  Online Cognitive Tests (pre- and post-study)&#xD;
&#xD;
        -  Wellbeing Questionnaires (pre- and post-study)&#xD;
&#xD;
        -  Physical Activity Assessments (before and during the study)&#xD;
&#xD;
        -  PE Teacher Training for Intervention Schools&#xD;
&#xD;
        -  Fitness (Beep) Tests (pre- and post-study)&#xD;
&#xD;
        -  NatCen will undertake an Independent Evaluation of the 'Fit to Study' programme.&#xD;
&#xD;
      In all schools, the pupils in the target year group will undergo baseline assessments (in the&#xD;
      final term of Year 7), which will comprise tests of physical fitness; cognitive assessments;&#xD;
      and questionnaires (about physical activity, sleep patterns, mood, motivation and wellbeing).&#xD;
      The tests of physical fitness will be administered during PE lessons and will involve&#xD;
      measures of speed and endurance. The school PE teachers will be involved in the&#xD;
      administration of these tests. The cognitive tests (which will include tests of memory,&#xD;
      executive functions and attention using button responses), and some of the questionnaires,&#xD;
      will be computer-based and may be administered over the web, at school or at home, using a&#xD;
      well-established online testing package.&#xD;
&#xD;
      PE teachers in the intervention condition schools will be trained to administer our&#xD;
      intervention. Our training package will comprise a set of focused lesson principles and&#xD;
      techniques for their delivery.&#xD;
&#xD;
      To foster friendly competition between schools, the investigators may produce&#xD;
      newsletters/bulletins containing school league tables indicating summary physical activity&#xD;
      levels during PE and/or proportion of assessments completed, but these will never contain&#xD;
      individual pupils' data.&#xD;
&#xD;
      The investigators will use activity monitors to compare physical activity during intervention&#xD;
      and control PE lessons. At the end of the intervention period (which is intended to be an&#xD;
      academic year), the Year 8 pupils in all schools will repeat the assessments.&#xD;
&#xD;
      In addition, the University of Oxford will be conducting a sub-study with a small number of&#xD;
      pupils from a subset of schools. This is an optional part of the project and will be subject&#xD;
      to separate written / informed consent from the pupils' parents/guardians. This will involve&#xD;
      MRI brain scanning at the University of Oxford, as well as additional fitness and cognitive&#xD;
      tests. Further detail will be made available to schools that are selected to take part in the&#xD;
      Main Study (from May 2017).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Single blind (outcome assessor)</masking_description>
  </study_design_info>
  <primary_outcome>
    <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).</measure>
    <time_frame>1 hour: Last month of the study (June 2018).</time_frame>
    <description>The Primary Outcome Measure is recorded on the ISRCTN registry with study ID ISRCTN15730512.&#xD;
Mathematical attainment as measured using the level 13 Progress in Maths test (provided at GL assessment) at the end of the school year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wellbeing Survey</measure>
    <time_frame>30 minutes: Baseline (June 2017) and final month of the study (June 2018)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Test of Attention and Reaction Time</measure>
    <time_frame>10 minutes: Baseline (June 2017) and final month of the study (June 2018)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Test of Memory (Image Associates)</measure>
    <time_frame>10 minutes: Baseline (June 2017) and final month of the study (June 2018)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eriksen Flanker Test</measure>
    <time_frame>10 minutes: Baseline (June 2017) and final month of the study (June 2018)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Test of Memory (Two-back Image Task)</measure>
    <time_frame>10 minutes: Baseline (June 2017) and final month of the study (June 2018)</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Test of Executive Function</measure>
    <time_frame>10 minutes: Baseline (June 2017) and final month of the study (June 2018)</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fitness Assessment (20m Beep Test)</measure>
    <time_frame>20 minutes: Baseline (June 2017) and final month of the study (June 2018)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Measurements</measure>
    <time_frame>60 minutes: Baseline (June 2017), at 14 weeks, at 28 weeks and final month of the study (June 2018).</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20000</enrollment>
  <condition>Physical Activity</condition>
  <condition>Mental Health Wellness 1</condition>
  <condition>Cognitive Function 1, Social</condition>
  <condition>Academic Attainment</condition>
  <condition>Fitness Testing</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The Control Group will be asked to continue with their normal PE lessons.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>'Physical Education (PE) Programme'</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Education (PE) Programme</intervention_name>
    <description>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.&#xD;
The Intervention involves roughly 20 minutes of prescribed activities per week, to be delivered within school PE lessons.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion is by school year group - typically aged 11-14:&#xD;
&#xD;
          -  Year 7 pupils during the academic year 2016/17 (Age 11-12, KS3).&#xD;
&#xD;
          -  Year 8 pupils during the academic year 2017/18 (Age 12-13, KS3).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any pupils that are exempted from PE.&#xD;
&#xD;
          -  Pupils that have 'opted out' of data sharing / storage for research purposes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helen Dawes</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oxford Brookes University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oxford Brookes University</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 0BP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>April 18, 2022</last_update_submitted>
  <last_update_submitted_qc>April 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oxford Brookes University</investigator_affiliation>
    <investigator_full_name>Helen Dawes</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03286725
org study id: EEF2681
nct id: NCT03286725
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Single blind (outcome assessor)
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).
time frame: 1 hour: Last month of the study (June 2018).
description: 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.
measure: Wellbeing Survey
time frame: 30 minutes: Baseline (June 2017) and final month of the study (June 2018)
description: 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.
measure: Cognitive Test of Attention and Reaction Time
time frame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
description: 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.
measure: Cognitive Test of Memory (Image Associates)
time frame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
description: 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.
measure: Eriksen Flanker Test
time frame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
description: 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.
measure: Cognitive Test of Memory (Two-back Image Task)
time frame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
description: 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).
measure: Cognitive Test of Executive Function
time frame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
description: 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).
measure: Fitness Assessment (20m Beep Test)
time frame: 20 minutes: Baseline (June 2017) and final month of the study (June 2018)
description: 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.
measure: Physical Activity Measurements
time frame: 60 minutes: Baseline (June 2017), at 14 weeks, at 28 weeks and final month of the study (June 2018).
description: 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).
arm group label: Control Group
arm group type: No Intervention
description: The Control Group will be asked to continue with their normal PE lessons.
arm group label: Intervention Group
arm group type: Experimental
description: 'Physical Education (PE) Programme'
intervention type: Behavioral
intervention name: Physical Education (PE) Programme
description: 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.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 11 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Helen Dawes
role: Principal Investigator
affiliation: Oxford Brookes University
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Oxford Brookes University
investigator full name: Helen Dawes
investigator title: Principal Investigator
sharing ipd: Yes
ipd description: 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.