Physical ActivityNCT03593863
The Effects of an In-school Physical Activity Intervention on Adolescents' Brain Structure and Function
A study testing Physical Education (PE) programme in people with Physical Activity, run by University of Oxford at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Physical Education (PE) programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2017to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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:
- Enrolled in the Fit to Study Main Trial
- English speaking
Show all 15Show fewer
- 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:
- 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
Who cannot join
- Contraindication to MRI
- Contraindication to VO2max fitness test
- Cohort 2
- School level:
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wellcome Centre for Integrative Neuroimaging (WIN)
Oxford
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- 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)
- 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:
- To examine cross-sectional relations between anterior hippocampal volume and physical activity and fitness at baseline (cohort 1)
- 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:
- To examine cross-sectional relations between brain structure and function, and physical activity and fitness at baseline (cohort 1)
- 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)
- To examine whether brain organisation, mental health, cognitive performance and fitness is different in the intervention group compared to the control group post intervention
- To identify MRI markers predisposing the PA intervention effect
- Conditions
- Physical Activity
- Being tested
- Physical Education (PE) programme
- Keywords
- Brain structure and function, Adolescents, Physical activity, Cognitive function, Mental health, Fitness
- Medical subject headings
- Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Education (PE) programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| "PE as Usual" Control Group | No intervention | The Control Group will be asked to continue with their normal PE lessons |
| Intervention Group | Experimental | Physical Education (PE) Programme Receives: Behavioral: Physical Education (PE) programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior hippocampal volume (change)
Change in anterior hippocampal volume is derived using a T1-weighted magnetic resonance imaging (MRI) sequence.
Measured: 5mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018)
Secondary outcomes (11)
Structural magnetic resonance imaging
Measures of brain structure (Completed by cohort 1 and 2)
Measured: 35mins, Baseline/pre-intervention (July - September 2017) and after 1 year (May - September 2018)
Functional magnetic resonance imaging
Measures of brain function (Completed by cohort 1 and 2)
Measured: 15mins, Baseline/pre-intervention(July - September 2017) and after 1 year (May - September 2018)
Memory function [cognitive functioning]
Object location memory task. (This assessment is completed by cohort 1 and 2)
Measured: 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]
Relational memory task (This assessment is completed by cohort 1 only)
Measured: 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]
Colour-shape switch task (This assessment is completed by cohort 1 only)
Measured: 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]
Tower of London task (This assessment is completed by cohort 2 only)
Measured: 5mins, after 1 year (May-August 2018), and at follow-up after 23 months (June 2018)
Implicit mental biases [cognitive functioning]
Mental biases are assessed using the implicit association task (This assessment is completed by cohort 1 only)
Measured: 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
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)
Measured: 30mins, Baseline/pre-intervention (July - September 2017), after 1 year (July - September 2018) and at follow-up after 23 months (June 2018)
Fitness
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.
Measured: 30mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018)
Objective physical activity
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)
Measured: 7-days, Baseline/pre-intervention (September 2017), after 10 months (June/July 2018), and at follow-up after 22 months (June 2019)
Gait
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)
Measured: 5mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start1 May 2017
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Fit to Study brain imaging study is embedded in the Fit to Study trial, which is a parallel group, superiority cluster-randomised efficacy trial of a 10-month (one academic year) vigorous physical activity (VPA) intervention versus control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Brookes University
- Responsible party
- Sponsor
- Investigators
- Heidi Johansen-Berg, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593863
- Sponsor's protocol ID
- HMR00670
- Other IDs
- EEF2681
- Status last verified
- Jul 2018
- First submitted
- 9 May 2018
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated during and/or analysed as part of the brain imaging sub-study are available from the principal investigator upon reasonable request.
Publications
Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
PubMed 34555181Wassenaar TM, Wheatley CM, Beale N, Salvan P, Meaney A, Possee JB, Atherton KE, Duda JL, Dawes H, Johansen-Berg H. Effects of a programme of vigorous physical activity during secondary school physical education on academic performance, fitness, cognition, mental health and the brain of adolescents (Fit to Study): study protocol for a cluster-randomised trial. Trials. 2019 Apr 2;20(1):189. doi: 10.1186/s13063-019-3279-6.
PubMed 30940164
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an In-school Physical Activity Intervention on Adolescents' Brain Structure and Function ('Fit to Study' Brain Imaging Sub-study)
- ClinicalTrials.gov ID
- NCT03593863
- Acronym / sponsor ID
- HMR00670
- Conditions
- Physical Activity
- Keywords
- Brain structure and function, Adolescents, Physical activity, Cognitive function, Mental health, Fitness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford Brookes University
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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)
- 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:
- To examine cross-sectional relations between anterior hippocampal volume and physical activity and fitness at baseline (cohort 1)
- 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:
- To examine cross-sectional relations between brain structure and function, and physical activity and fitness at baseline (cohort 1)
- 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)
- To examine whether brain organisation, mental health, cognitive performance and fitness is different in the intervention group compared to the control group post intervention
- To identify MRI markers predisposing the PA intervention effect
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The Fit to Study brain imaging study is embedded in the Fit to Study trial, which is a parallel group, superiority cluster-randomised efficacy trial of a 10-month (one academic year) vigorous physical activity (VPA) intervention versus control.
| Arm | Type | Receives |
|---|---|---|
| "PE as Usual" Control Group | No intervention | –The Control Group will be asked to continue with their normal PE lessons |
| Intervention Group | Experimental | Behavioral: Physical Education (PE) programmePhysical Education (PE) Programme |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (6 listed)
- Cohort 2
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Education (PE) programmeThe 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. | Behavioural | Intervention Group |
Primary outcome
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.
11 secondary outcomes
Structural magnetic resonance imaging
Time frame: 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)
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)
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)
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)
Planning [cognitive functioning]
Time frame: 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 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)
Fitness
Time frame: 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)
Gait
Time frame: 5mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Derived from this study: PubMed 34555181Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
- Derived from this study: PubMed 30940164Wassenaar TM, Wheatley CM, Beale N, Salvan P, Meaney A, Possee JB, Atherton KE, Duda JL, Dawes H, Johansen-Berg H. Effects of a programme of vigorous physical activity during secondary school physical education on academic performance, fitness, cognition, mental health and the brain of adolescents (Fit to Study): study protocol for a cluster-randomised trial. Trials. 2019 Apr 2;20(1):189. doi: 10.1186/s13063-019-3279-6.
- Individual participant dataSharing planned: Undecided. The datasets generated during and/or analysed as part of the brain imaging sub-study are available from the principal investigator upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Johansen-Berg principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Education (PE) programme in people with Physical Activity, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior hippocampal volume (change) (time frame: 5mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03593863, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.