An interventional study of Physical Education (PE) Programme in Physical Activity, Mental Health Wellness 1 and Cognitive Function 1, Social, sponsored by Oxford Brookes University. Completed at 1 site in United Kingdom. Open to participants aged 11 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-20.
Sponsored by Oxford Brookes University · Not applicable, Interventional, and Treatment
Among 387 studies in Motor Activity with a site in United Kingdom — 62 open to participants now, 76 under way, none of them phase 3. Motor Activity · United Kingdom.
Among the 387 studies in Motor Activity with a site in United Kingdom, this one has the largest enrollment of the 316 interventional ones that give a count, is one of 34 that started in 2017, is one of 290 with no phase, and was the 136th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →62 of the 387 studies in Motor Activity with a site in United Kingdom are open now. Recruiting first, the newest first:
Sports Performance and Applied Research in Trials and Analysis · Sites in United Kingdom
Dr. Chris Gaffney · Sites in United Kingdom
University of Surrey · Sites in United Kingdom
Sports Performance and Applied Research in Trials and Analysis · Sites in United Kingdom
Queen's University, Belfast · Sites in United Kingdom
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 11 Years to 14 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
387 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 13 · Phase 3 6 · Phase 4 2
First in 2002; this study’s year is marked. 34 started in 2017.
This study's enrollment of 20,000 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 42 across the 316 interventional studies, 60 across the 71 observational. Of the 248 that completed or were terminated, 21 (8%) have results posted.
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11 of 387 have an industry lead sponsor. The 10 most frequent:
Oxford Brookes University is the lead sponsor of 35 studies on the registry; 6 are open to participants now.
Oxford Brookes University has 3 studies filed under Motor Activity — fewer than ten, so there is no comparison to draw.
19 of the studies in Motor Activity with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06017934University of SouthamptonPromoting Increased Physical Activity in Hospitalised Older Adults | 2026-11 |
| NCT07594444Sports Performance and Applied Research in Trials and AnalysisWhey Protein and Adaptogenic Supplementation in Physically Active Females | 2026-11-20 |
| NCT07716904Sports Performance and Applied Research in Trials and AnalysisWhey Protein and Adaptogenic Supplementation in Physically Active Males | 2026-11-20 |
| NCT05889598Loughborough UniversityResistance Exercise Training to Improve Bone and Articular Cartilage Health in Women | 2026-12-31 |
| NCT07554677Queen's University, BelfastUnderstanding the Feasibility of a Co-designed Pre-radiotherapy Exercise Programme - A Single-arm Study | 2027-01-14 |
Among the 387 studies in Motor Activity with a site in United Kingdom, from their registry updates:
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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:
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion is by school year group - typically aged 11-14:
Exclusion Criteria:
The Control Group will be asked to continue with their normal PE lessons.
'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.
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).
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.
Time frame: 1 hour: Last month of the study (June 2018).
Wellbeing Survey
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.
Time frame: 30 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Attention and Reaction Time
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.
Time frame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Memory (Image Associates)
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.
Time frame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Eriksen Flanker Test
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.
Time frame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Memory (Two-back Image Task)
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).
Time frame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Cognitive Test of Executive Function
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).
Time frame: 10 minutes: Baseline (June 2017) and final month of the study (June 2018)
Fitness Assessment (20m Beep Test)
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.
Time frame: 20 minutes: Baseline (June 2017) and final month of the study (June 2018)
Physical Activity Measurements
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).
Time frame: 60 minutes: Baseline (June 2017), at 14 weeks, at 28 weeks and final month of the study (June 2018).
Plan to share: Yes — 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.
Ran from May 2017 to primary completion in Jul 2019, 26 months.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 26 months is above that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Oxford Brookes University