ChiCTR2400080109 版本V1.0 版本创建时间2024/01/19 18:26:59 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400080109 

最近更新日期：

Date of Last Refreshed on：

2024-01-19 18:26:49 

注册时间：

Date of Registration：

2024-01-19 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Ruiyuan Tao 

研究负责人：

Cindy Huiping SIT 

Applicant：

Ruiyuan Tao 

Study leader：

Cindy Huiping SIT 

申请注册联系人电话：

Applicant telephone：

+852 3943 0694

研究负责人电话：

Study leader's telephone：

+852 3943 4126

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

rytao@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

sithp@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

Kowk Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong

研究负责人通讯地址：

Kowk Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong

Applicant address：

Kowk Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong

Study leader's address：

Kowk Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

Department of Sports Science and Physical Education, The Chinese University of Hong Kong

Applicant's institution：

Department of Sports Science and Physical Education, The Chinese University of Hong Kong

研究负责人所在单位：

Department of Sports Science and Physical Education, The Chinese University of Hong Kong

Affiliation of the Leader：

Department of Sports Science and Physical Education, The Chinese University of Hong Kong

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2022.482-T

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2022-10-13 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 3505 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Kwok Sports Building Faculty of Education, The Chinese University of Hong Kong Shatin, New Territories, Hong Kong, China

Primary sponsor's address：

Kwok Sports Building Faculty of Education, The Chinese University of Hong Kong Shatin, New Territories, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

N/A

省(直辖市)：

N/A

市(区县)：

N/A

Country：

N/A

Province：

N/A

City：

N/A

单位(医院)：

N/A

具体地址：

N/A

Institution
hospital：

N/A

Address：

N/A

经费或物资来源：

Hong Kong University Grants Committee

Source(s) of funding：

Hong Kong University Grants Committee

Target disease：

ADHD

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

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.  

Objectives of Study：

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.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

(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.

Inclusion criteria

(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.

Exclusion criteria：

(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.

研究实施时间：

Study execute time：

从 From 2022-11-15 00:00:00至 To 2025-11-15 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-07-01 00:00:00 至 To 2024-03-01 00:00:00  

干预措施：

Interventions：

组别：

Experimental Group

样本量：

60

Group：

Experimental Group

Sample size：

干预措施：

Cognitively-engaged Physical Activity

干预措施代码：

Intervention：

Cognitively-engaged Physical Activity

Intervention code：

组别：

Active Control Group

样本量：

60

Group：

Active Control Group

Sample size：

干预措施：

Aerobic exercise

干预措施代码：

Intervention：

Aerobic exercise

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China 

Province：

Hong Kong 

City：

 

单位(医院)：

Six primary schools in Hong Kong 

单位级别：

N/A 

Institution
hospital：

Six primary schools in Hong Kong

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

Mental health

指标类型：

次要指标

Outcome：

Mental health

Type：

Secondary indicator

测量时间点：

baseline, post-intervention, 3-month and 12 month follow-up

测量方法：

Questionnaire

Measure time point of outcome：

baseline, post-intervention, 3-month and 12 month follow-up

Measure method：

Questionnaire

指标中文名：

Behavior problems

指标类型：

次要指标

Outcome：

Behavior problems

Type：

Secondary indicator

测量时间点：

baseline, post-intervention, 3-month and 12 month follow-up

测量方法：

Questionnaire

Measure time point of outcome：

baseline, post-intervention, 3-month and 12 month follow-up

Measure method：

Questionnaire

指标中文名：

Neurophysiological parameters

指标类型：

主要指标

Outcome：

Neurophysiological parameters

Type：

Primary indicator

测量时间点：

baseline, post-intervention, 3-month and 12 month follow-up

测量方法：

Electroencephalogram

Measure time point of outcome：

baseline, post-intervention, 3-month and 12 month follow-up

Measure method：

Electroencephalogram

指标中文名：

Attentional control

指标类型：

主要指标

Outcome：

Attentional control

Type：

Primary indicator

测量时间点：

baseline, post-intervention, 3-month and 12 month follow-up

测量方法：

computer-based Posner paradigm

Measure time point of outcome：

baseline, post-intervention, 3-month and 12 month follow-up

Measure method：

computer-based Posner paradigm

指标中文名：

Inhibitory control

指标类型：

主要指标

Outcome：

Attentional control

Type：

Primary indicator

测量时间点：

baseline, post-intervention, 3-month and 12 month follow-up

测量方法：

Flanker test

Measure time point of outcome：

baseline, post-intervention, 3-month and 12 month follow-up

Measure method：

Flanker test

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 6 岁 years
最大 Max age 11 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

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.

Randomization Procedure (please state who generates the random number sequence and by what method)：

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.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

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

Blinding：

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

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

N/A

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

N/A

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

N/A

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

N/A

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-01-19 18:26:49