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

February 27, 2019 updated by: University of Oxford

The Effects of an In-school Physical Activity Intervention on Adolescents' Brain Structure and Function ('Fit to Study' Brain Imaging Sub-study)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom
        • Wellcome Centre for Integrative Neuroimaging (WIN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  1. Cohort 1:

    School level:

    Inclusion criteria

    • Enrolled in the the Fit to Study Main trial
    • Within a 75 miles radius from Oxford
    • Lower lower socio-economic background, as indicated by percentage of free school meal (FSM)-eligible pupils or postcode-derived index of multiple deprivation

    Pupil level:

    Inclusion criteria

    • Enrolled in the Fit to Study Main Trial
    • English speaking

    Exclusion criteria

    • Contraindication to MRI
    • Contraindication to VO2max fitness test
  2. Cohort 2

School level:

Inclusion criteria

  • High completion rates of baseline cognitive, questionnaire and fitness data relative to other schools
  • Responsive to messages from the Fit to Study research team
  • Lower socio-economic background, as indicated by the percentage of FSM or postcode-derived index of multiple deprivation
  • For intervention schools only: adherence to the intervention.

From those schools that met criteria, a sub-sample of 10 schools is chosen by the trial manager.

Pupil level:

Inclusion criteria

  • Low fitness compared to other pupils of their school who expressed an interest, based on their baseline fitness assessment (part of Fit to Study Main Trial)
  • Enrolled in the Fit to Study Main Trial
  • English speaking

Exclusion criteria

- Contraindication to MRI

If selected schools are not interested in the brain-imaging sub-study, these schools are replaced by other schools from the Fit to Study sample that are within reasonable travel distance (max 1.5h) from the brain imaging centre.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: "PE as Usual" 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
The intervention consists of a 10-month (one academic year, September-June) physical activity programme delivered by PE teachers during regular Year-8 PE lessons. The Intervention involves roughly 20 minutes of prescribed activities per week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anterior hippocampal volume (change)
Time Frame: 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.
5mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Structural magnetic resonance imaging
Time Frame: 35mins, Baseline/pre-intervention (July - September 2017) and after 1 year (May - September 2018)
Measures of brain structure (Completed by cohort 1 and 2)
35mins, Baseline/pre-intervention (July - September 2017) and after 1 year (May - September 2018)
Functional magnetic resonance imaging
Time Frame: 15mins, Baseline/pre-intervention(July - September 2017) and after 1 year (May - September 2018)
Measures of brain function (Completed by cohort 1 and 2)
15mins, Baseline/pre-intervention(July - September 2017) and after 1 year (May - September 2018)
Memory function [cognitive functioning]
Time Frame: 20mins, Baseline/pre-intervention (July - September 2017), after 1 year (July - September 2018) and at follow-up after 23 months (June 2018)
Object location memory task. (This assessment is completed by cohort 1 and 2)
20mins, Baseline/pre-intervention (July - September 2017), after 1 year (July - September 2018) and at follow-up after 23 months (June 2018)
Memory function [cognitive functioning]
Time Frame: 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)
7mins,Baseline/pre-intervention (July - September 2017), after 1 year (July - September 2018) and at follow-up after 23 months (June 2018)
Cognitive flexibility [cognitive functioning]
Time Frame: 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)
7mins, Baseline/pre-intervention (July - September 2017), after 1 year (July - September 2018) and at follow-up after 23 months (June 2018)
Planning [cognitive functioning]
Time Frame: 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)
5mins, after 1 year (May-August 2018), and at follow-up after 23 months (June 2018)
Implicit mental biases [cognitive functioning]
Time Frame: 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)
20mins, Baseline/pre-intervention (July - September 2017), after 1 year (July - September 2018) and at follow-up after 23 months (June 2018)
Mental health and well-being
Time Frame: 30mins, 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)
30mins, Baseline/pre-intervention (July - September 2017), after 1 year (July - September 2018) and at follow-up after 23 months (June 2018)
Fitness
Time Frame: 30mins, 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.
30mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018)
Objective physical activity
Time Frame: 7-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)
7-days, Baseline/pre-intervention (September 2017), after 10 months (June/July 2018), and at follow-up after 22 months (June 2019)
Gait
Time Frame: 5mins, 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)
5mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oxford

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Oxford Brookes University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heidi Johansen-Berg, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HMR00670
  • EEF2681 (Education Endowment Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The datasets generated during and/or analysed as part of the brain imaging sub-study are available from the principal investigator upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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