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【ChiCTR2400080109】A Randomized Controlled Trial of Physical Activity Intervention on Neurocognitive Performance, Mental Health, and Behavioural Outcomes of Children with Attention Deficit Hyperactivity Disorder

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基本信息

登记号

ChiCTR2400080109

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2024-01-19

临床申请受理号

靶点

适应症

ADHD

试验通俗题目

A Randomized Controlled Trial of Physical Activity Intervention on Neurocognitive Performance, Mental Health, and Behavioural Outcomes of Children with Attention Deficit Hyperactivity Disorder

试验专业题目

A Randomized Controlled Trial of Physical Activity Intervention on Neurocognitive Performance, Mental Health, and Behavioural Outcomes of Children with Attention Deficit Hyperactivity Disorder

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

1. Examine the immediate, short- and longer-term effects of a school-based physical activity intervention on neurocognitive performance (inhibitory control, attentional control), mental health (anxiety and depression), and behavioural outcomes (e.g., social withdrawal and aggressive behaviour) in children with ADHD. 2. Determine the potential influence of the moderating variables (gender, ADHD subtypes) on the intervention effects.

试验分类

试验类型

整群随机分组

试验分期

其它

随机化

Six schools will be cluster-randomized into either intervention schools or control schools using block size randomization in a 1:1 ratio. The random number sequence will be generated by an independent researcher. A computerized randomization tool will be used to create the random number sequence.

盲法

The results of the randomization will be kept confidential from the assessors.

试验项目经费来源

Hong Kong University Grants Committee

试验范围

目标入组人数

实际入组人数

第一例入组时间

2022-11-15

试验终止时间

2025-11-15

是否属于一致性

入选标准

(1) Children between the ages of 6 and 11 years diagnosed with ADHD, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; (2) capability to follow instructions of the researcher; (3) ability to carry out the prescribed physical activity intervention; (4) ability in reading and comprehending questionnaires; (5) no engagement in regular physical activity training within the last 6 months.；

排除标准

(1) Presence of other medical conditions restricting physical activity capacities; (2) Presence of a complex neurologic disorder (e.g., epilepsy, fragile X syndrome); and (3) Visual and auditory deficits.；

研究者信息

研究负责人姓名

试验机构

The Chinese University of Hong Kong

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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