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The Effects of an In-school Physical Activity Intervention on Adolescents' Brain Structure and Function

Not Applicable
Conditions
Physical Activity
Interventions
Behavioral: Physical Education (PE) programme
Registration Number
NCT03593863
Lead Sponsor
University of Oxford
Brief Summary

Physical activity has shown beneficial effects for cognitive and brain health, suggesting it may provide a highly scalable intervention to improve academic achievement. This project is part of a large-scale randomised controlled trial called Fit to Study (ClinicalTrials.gov ID: NCT03286725). The main Fit to Study trial aims to test the effect of a school-based physical activity intervention on academic performance (as well as cognition and physical measures) across Year 8 pupils in 100 secondary schools. The current study - the Fit to Study - Brain imaging sub-study - will target a sub-sample of participants in the large-scale trial, in order to test pre- to post intervention changes in hippocampal volume, as well as cognitive performance, mental health and brain organisation. We hypothesise that the intervention will change anterior hippocampal volume of Year-8 pupils, as well as mental health, cognitive performance, and more generally, brain structure and function. We further hypothesise that changes in brain organisation (e.g. hippocampal volume) may mediate changes in cognitive performance and mental health.

Detailed Description

Physical activity has shown beneficial effects for cognitive and brain health. In particular, studies have shown that physical activity has the potential to increase the volume of the anterior portion of the hippocampus, a brain structure involved in learning and memory. The Fit to Study - Brain imaging sub-study is being conducted to understand better the effects of a physical activity intervention delivered during school PE lessons on anterior hippocampal volume, as well as cognition, mental health, and brain organisation.

The Fit to Study main trial aims to test the effect of a school-based physical activity intervention on academic performance (as well as cognition and physical measures) across Year 8 pupils in 100 secondary schools. A full description of the Fit to study main trail, including its outcome measures, has been provided as part of its registration at ClinicalTrials.gov (NCT03286725).

The Fit to Study - Brain imaging sub-study will target a sub-sample of participants of the large-scale trial, in order to test pre to post intervention changes in anterior hippocampal volume, as well as cognitive performance, mental health and brain organisation. The assessments will take place pre-intervention, immediately post-intervention and 12-months post-intervention, and will comprise structural and functional magnetic resonance imaging (MRI) scans.

Fit to Study main trial participants are considered eligible for brain imaging sub-study. The brain imaging sub-study consists of two sub-samples, recruited at different times during the trial:

1. The first cohort of 60 participants completed assessments pre-intervention, will complete identical assessments post-intervention to investigate pre-to-post intervention changes, and will be invited to take part in follow-up assessments.

2. A second cohort of \~50 participants will be recruited for post-intervention assessments that are similar, but not identical, to the assessments of the first group, as well as 1-year follow-up assessments. This cohort will enable cross-sectional analysis of between-group (intervention-control) differences in a larger sample.

The assessments are similar, but not identical for the two cohorts. The key assessments are listed here and details are provided in the 'outcome measures' section.

1. Cohort 1

* Magnetic resonance imaging (at pre- and post intervention)

* Computer-based cognitive tasks (at pre-, and post intervention and follow-up)

* Mental health questionnaires (at pre-, and post intervention and follow-up)

* Physical activity assessments (at pre-, and post intervention, and follow-up)

* Fitness assessments (at pre-, and post intervention)

* Gait assessments (at pre- and post intervention)

2. Cohort 2

* Magnetic resonance imaging (at post intervention only)

* Computer-based cognitive tasks (at post intervention and follow-up)

* Mental health questionnaires (at post intervention and follow-up)

* Physical activity assessments (at post intervention and follow-up)

* Gait assessments (at post-intervention only)

The primary aims of the study are:

1. To examine cross-sectional relations between anterior hippocampal volume and physical activity and fitness at baseline (cohort 1)

2. To examine whether changes in anterior hippocampal volume are greater in the intervention group compared to the control group (i.e. group by time interaction tested in cohort 1)

Secondary aims are:

1. To examine cross-sectional relations between brain structure and function, and physical activity and fitness at baseline (cohort 1)

2. To examine whether changes in brain organisation, mental health, cognitive performance and fitness are greater in the intervention group compared to the control group (i.e. group by time interaction tested in cohort 1)

3. To examine whether brain organisation, mental health, cognitive performance and fitness is different in the intervention group compared to the control group post intervention

4. To identify MRI markers predisposing the PA intervention effect

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
103
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention GroupPhysical Education (PE) programmePhysical Education (PE) Programme
Primary Outcome Measures
NameTimeMethod
Anterior hippocampal volume (change)5mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018)

Change in anterior hippocampal volume is derived using a T1-weighted magnetic resonance imaging (MRI) sequence.

Secondary Outcome Measures
NameTimeMethod
Functional magnetic resonance imaging15mins, Baseline/pre-intervention(July - September 2017) and after 1 year (May - September 2018)

Measures of brain function (Completed by cohort 1 and 2)

Memory function [cognitive functioning]7mins,Baseline/pre-intervention (July - September 2017), after 1 year (July - September 2018) and at follow-up after 23 months (June 2018)

Relational memory task (This assessment is completed by cohort 1 only)

Cognitive flexibility [cognitive functioning]7mins, Baseline/pre-intervention (July - September 2017), after 1 year (July - September 2018) and at follow-up after 23 months (June 2018)

Colour-shape switch task (This assessment is completed by cohort 1 only)

Implicit mental biases [cognitive functioning]20mins, Baseline/pre-intervention (July - September 2017), after 1 year (July - September 2018) and at follow-up after 23 months (June 2018)

Mental biases are assessed using the implicit association task (This assessment is completed by cohort 1 only)

Fitness30mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018)

An incremental step test on a cycle ergometer is used to measure maximal oxygen consumption (VO2max), an objective measure of cardiorespiratory fitness. (This assessment is completed by cohort 1 only)

The 20m shuttle run (beep) test is part of the Fit to Study main trial and is therefore completed in school by both cohorts.

Structural magnetic resonance imaging35mins, Baseline/pre-intervention (July - September 2017) and after 1 year (May - September 2018)

Measures of brain structure (Completed by cohort 1 and 2)

Planning [cognitive functioning]5mins, after 1 year (May-August 2018), and at follow-up after 23 months (June 2018)

Tower of London task (This assessment is completed by cohort 2 only)

Mental health and well-being30mins, Baseline/pre-intervention (July - September 2017), after 1 year (July - September 2018) and at follow-up after 23 months (June 2018)

A battery of surveys each including a number of measures:

To assess symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) a parent of the participant completed the ADHD rating scale. Puberty status is assessed using the Pubertal Development Rating Scale. Mood is assessed using the abbreviated Profile of Mood States (POMS). The abbreviated POMS scale is a questionnaire that contains 40 self-report items on a five-point Likert scale. Sleep is assessed using the Cleveland Adolescent Sleepiness Questionnaire (CASQ and the Sleep Condition Indicator (SCI). The CASQ is a self-report scale to measure excessive daytime sleepiness. The SCI is an 8-item self-report measure of insomnia symptoms.Mental health is assessed with the Strength and Difficulties Questionnaire. General health and behaviour is assessed using various items of the Health Behaviour for School Aged Children (HBSC) survey (2009/2010).

(This battery is completed by cohort 1 and 2)

Objective physical activity7-days, Baseline/pre-intervention (September 2017), after 10 months (June/July 2018), and at follow-up after 22 months (June 2019)

Daily average MVPA during a typical week in school term is measured using the wrist-mounted Axivity AX3 accelerometer. (This assessment is completed by cohort 1 and 2)

Gait5mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018)

Participants walk over a 10m obstacle-free and flat surface walkway, while wearing a single inertial measurement unit to obtain temporal and spatial gait parameters. (This assessment is completed by cohort 1 and 2)

Trial Locations

Locations (1)

Wellcome Centre for Integrative Neuroimaging (WIN)

🇬🇧

Oxford, United Kingdom

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