ChiCTR2400087025 版本V1.0 版本创建时间2024/07/17 15:53:41 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：

 ChiCTR2400087025 

最近更新日期：

Date of Last Refreshed on：

 2024-07-17 15:53:37 

注册时间：

Date of Registration：

 2024-07-17 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Running for Development for ADHD youth

Public title：

Running for Development for ADHD youth

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Running for Development for ADHD youth

Scientific title：

Running for Development for ADHD youth

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：

Chang Liu 

研究负责人：

Cindy Hui-ping Sit 

Applicant：

Chang Liu 

Study leader：

Cindy Hui-ping Sit 

申请注册联系人电话：

Applicant telephone：

 +86 189 1016 7331

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：

 1155168211@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：

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

研究负责人通讯地址：

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

Applicant address：

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

Study leader's address：

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

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, Hong Kong, China

Applicant's institution：

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

研究负责人所在单位：

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

Affiliation of the Leader：

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

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2021.645

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：

 2022-12-10 00:00:00

伦理委员会联系人：

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

Contact Name of the ethic committee：

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

伦理委员会联系地址：

8/f, Lui Che Woo Clinical Science Building, Prince of Wales Hospital, Shatin, Hong Kong

Contact Address of the ethic committee：

8/f, Lui Che Woo Clinical Science 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：

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

Primary sponsor：

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

研究实施负责（组长）单位地址：

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

Primary sponsor's address：

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

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

The Chinese University of Hong Kong

具体地址：

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

Institution
hospital：

Department of Sports Science and Physical Education

Address：

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

经费或物资来源：

Laureus Sport for Good Foundation

Source(s) of funding：

Laureus Sport for Good Foundation

研究疾病：

Mental health  

Target disease：

Mental health

研究疾病代码：

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：

随机抽样 

Study design：

Randomly Sampling 

研究目的：

To examine the effects of physical activity on mental health in adolescents with attention-deficit hyperactivity disorder.  

Objectives of Study：

To examine the effects of physical activity on mental health in adolescents with attention-deficit hyperactivity disorder.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Participants were recruited from five secondary schools in Hong Kong. Participants were eligible for inclusion if they were aged 12-17, clinically diagnosed with ADHD according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) by a psychiatrist and able to understand and complete the questionnaires.

Inclusion criteria

Participants were recruited from five secondary schools in Hong Kong. Participants were eligible for inclusion if they were aged 12-17, clinically diagnosed with ADHD according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) by a psychiatrist and able to understand and complete the questionnaires.

排除标准：

Exclusion criteria included: (1) medication use (e.g., antidepressants), (2) with other health problems (e.g., asthma disease) that might hinder their PA involvement, (3) participating in another behavioral or exercise trial and (4) with other psychiatry disorders

Exclusion criteria：

Exclusion criteria included: (1) medication use (e.g., antidepressants), (2) with other health problems (e.g., asthma disease) that might hinder their PA involvement, (3) participating in another behavioral or exercise trial and (4) with other psychiatry disorders

研究实施时间：

Study execute time：

从 From 2022-12-10 00:00:00至 To 2023-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-12-11 00:00:00 至 To 2022-12-31 00:00:00

干预措施：

Interventions：

组别：

A

样本量：

 40

Group：

A

Sample size：

干预措施：

Participants in the exercise group attended a weekly 60-minute session of aerobic exercise, for 12 weeks. This program was designed as progressive and stepwise, which included activities that could enhance motor skills, social skills, and social participation. Each session was delivered by a trained coach, assisted by at least one teacher and at least one research assistant, to achieve an instructor-to-participant ratio of around 1:3. The coaches were from a non-profit running organization that had been launched over 10 years ago. Each intervention session consisted of the following 3 parts: warm-up (10 min), aerobic exercise (40 min), and cool-down (10 min). In the first 6 sessions, interventions were conducted on school grounds. The aerobic activities were based on fun and less physically demanding practices and mini games to gradually improve participants’ fitness and motor skills, including balancing, plyometric and coordination (e.g., complex hopscotch and running with obstacles). The intensity was from light to moderate. In the last 6 sessions, running activities were conducted on local streets in different neighborhoods in Hong Kong to build up their sense of belonging to the society and to broaden their exposure to different locales, landmarks, and sights. In selected sessions, the participants’ families were invited to join to run at least a part of the route. Some running sessions were infused with a volunteering/service component, where the participants provided services to other needed groups, such as delivering gifts to the elderlies. We also organized sessions in which the participants ran with other students without ADHD. The intensity of running activity in the last 6 sessions was around moderate to vigorous.

干预措施代码：

Intervention：

Participants in the exercise group attended a weekly 60-minute session of aerobic exercise, for 12 weeks. This program was designed as progressive and stepwise, which included activities that could enhance motor skills, social skills, and social participation. Each session was delivered by a trained coach, assisted by at least one teacher and at least one research assistant, to achieve an instructor-to-participant ratio of around 1:3. The coaches were from a non-profit running organization that had been launched over 10 years ago. Each intervention session consisted of the following 3 parts: warm-up (10 min), aerobic exercise (40 min), and cool-down (10 min). In the first 6 sessions, interventions were conducted on school grounds. The aerobic activities were based on fun and less physically demanding practices and mini games to gradually improve participants’ fitness and motor skills, including balancing, plyometric and coordination (e.g., complex hopscotch and running with obstacles). The intensity was from light to moderate. In the last 6 sessions, running activities were conducted on local streets in different neighborhoods in Hong Kong to build up their sense of belonging to the society and to broaden their exposure to different locales, landmarks, and sights. In selected sessions, the participants’ families were invited to join to run at least a part of the route. Some running sessions were infused with a volunteering/service component, where the participants provided services to other needed groups, such as delivering gifts to the elderlies. We also organized sessions in which the participants ran with other students without ADHD. The intensity of running activity in the last 6 sessions was around moderate to vigorous.

Intervention code：

组别：

B

样本量：

 40

Group：

B

Sample size：

干预措施：

Follow daily routine

干预措施代码：

Intervention：

Follow daily routine

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)：

 Secondary schools' play ground 

单位级别：

 N/A 

Institution
hospital：

Secondary schools' play ground

Level of the institution：

N/A

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Streets and neighborhood 

单位级别：

 N/A 

Institution
hospital：

Streets and neighborhood

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

Internalizing problems

指标类型：

主要指标

Outcome：

Internalizing problems (e.g., depression, anxiety, stress)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Psychological well-being

指标类型：

次要指标

Outcome：

Psychological well-being

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Cognitive function

指标类型：

次要指标

Outcome：

Cognitive function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Suicidal ideation

指标类型：

次要指标

Outcome：

Suicidal ideation

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Sleep disorders

指标类型：

次要指标

Outcome：

Sleep disorders

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Physical self-concept

指标类型：

次要指标

Outcome：

Physical self-concept

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Externalizing problems (e.g., aggression)

指标类型：

主要指标

Outcome：

Externalizing problems (e.g., aggression)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 12 岁 years
最大 Max age 17 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）：

Participants were randomly allocated to exercise or control groups at a 1:1 ratio through a computer-based permuted block randomization with a block size of 8 by an independent research assistant.

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

Participants were randomly allocated to exercise or control groups at a 1:1 ratio through a computer-based permuted block randomization with a block size of 8 by an independent research assistant.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

The exercise instructors, and the trained outcome assessors were masked to the group allocation.

Blinding：

The exercise instructors, and the trained outcome assessors were masked to the group allocation.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否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）：

ResMan, http://www.medresman.org.cn/login.aspx

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

ResMan, http://www.medresman.org.cn/login.aspx

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：

ResMan, http://www.medresman.org.cn/login.aspx

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

ResMan, http://www.medresman.org.cn/login.aspx

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：

  2024-07-17 15:53:37