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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03286725
Recruitment Status : Unknown
Verified September 2017 by Helen Dawes, Oxford Brookes University.
Recruitment status was:  Active, not recruiting
First Posted : September 18, 2017
Last Update Posted : September 18, 2017
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
Helen Dawes, Oxford Brookes University

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.

Condition or disease Intervention/treatment Phase
Physical Activity Mental Health Wellness 1 Cognitive Function 1, Social Academic Attainment Fitness Testing Behavioral: Physical Education (PE) Programme Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Single (Outcomes Assessor)
Masking Description: Single blind (outcome assessor)
Primary Purpose: Treatment
Official Title: Physical Exercise for Education ('Fit to Study')
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group
The Control Group will be asked to continue with their normal PE lessons.
Experimental: Intervention Group
'Physical Education (PE) Programme'
Behavioral: 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.





Primary Outcome Measures :
  1. 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). ]

    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.



Secondary Outcome Measures :
  1. Wellbeing Survey [ Time Frame: 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.

  2. Cognitive Test of Attention and Reaction Time [ Time Frame: 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.

  3. Cognitive Test of Memory (Image Associates) [ Time Frame: 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.

  4. Eriksen Flanker Test [ Time Frame: 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.

  5. Cognitive Test of Memory (Two-back Image Task) [ Time Frame: 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).

  6. Cognitive Test of Executive Function [ Time Frame: 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).

  7. Fitness Assessment (20m Beep Test) [ Time Frame: 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.

  8. Physical Activity Measurements [ Time Frame: 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).



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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286725


Locations
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United Kingdom
Oxford Brookes University
Oxford, Oxfordshire, United Kingdom, OX3 0BP
Sponsors and Collaborators
Oxford Brookes University
University of Oxford
Investigators
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Principal Investigator: Helen Dawes Oxford Brookes University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helen Dawes, Principal Investigator, Oxford Brookes University
ClinicalTrials.gov Identifier: NCT03286725    
Other Study ID Numbers: EEF2681
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No