The Effects of an In-school Physical Activity Intervention on Adolescents' Brain Structure and Function ('Fit to Study' Brain Imaging Sub-study)
试验速览
- 阶段
- 不适用
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Anterior hippocampal volume (change)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
"PE as Usual" Control Group
The Control Group will be asked to continue with their normal PE lessons
Intervention Group
Physical Education (PE) Programme
干预措施: Physical Education (PE) programme (Behavioral)
结局指标
主要结局
Anterior hippocampal volume (change)
时间窗: 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.
次要结局
- Functional magnetic resonance imaging(15mins, Baseline/pre-intervention(July - September 2017) and after 1 year (May - September 2018))
- 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))
- 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))
- 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))
- Fitness(30mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018))
- Structural magnetic resonance imaging(35mins, Baseline/pre-intervention (July - September 2017) and after 1 year (May - September 2018))
- Planning [cognitive functioning](5mins, after 1 year (May-August 2018), and at follow-up after 23 months (June 2018))
- Mental health and well-being(30mins, Baseline/pre-intervention (July - September 2017), after 1 year (July - September 2018) and at follow-up after 23 months (June 2018))
- Objective physical activity(7-days, Baseline/pre-intervention (September 2017), after 10 months (June/July 2018), and at follow-up after 22 months (June 2019))
- Gait(5mins, Baseline/pre-intervention (July - September 2017) and after 1 year (July - September 2018))
