ChiCTR2600119667 版本V1.0 版本创建时间2026/03/02 11:35:44 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：

 ChiCTR2600119667 

最近更新日期：

Date of Last Refreshed on：

 2026-03-02 11:35:39 

注册时间：

Date of Registration：

 2026-03-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effects of High-Intensity Interval Training on Physical Fitness, Cognitive and Mental Health in Hong Kong Adolescents with Intellectual Disabilities: A Cluster-Randomized Controlled Trial

Public title：

Effects of High-Intensity Interval Training on Physical Fitness, Cognitive and Mental Health in Hong Kong Adolescents with Intellectual Disabilities: A Cluster-Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effects of High-Intensity Interval Training on Physical Fitness, Cognitive and Mental Health in Hong Kong Adolescents with Intellectual Disabilities: A Cluster-Randomized Controlled Trial

Scientific title：

Effects of High-Intensity Interval Training on Physical Fitness, Cognitive and Mental Health in Hong Kong Adolescents with Intellectual Disabilities: A Cluster-Randomized Controlled Trial

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：

Wong Po San 

研究负责人：

Eric Tsz-chun POON 

Applicant：

Wong Po San 

Study leader：

Eric Tsz-chun POON 

申请注册联系人电话：

Applicant telephone：

 +852 3943 6085

研究负责人电话：

Study leader's
telephone：

+852 3943 7157

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：

 sunwong@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 eric.poon@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：

G02, Kwok Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, N.T. Hong Kong.

研究负责人通讯地址：

G02, Kwok Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, N.T. Hong Kong.

Applicant address：

G02, Kwok Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, N.T. Hong Kong.

Study leader's address：

G02, Kwok Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, N.T. 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

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2024.410-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：

 2025-05-28 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, HK

Contact Address of the ethic committee：

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

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：

Kowk Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

Primary sponsor's address：

Kowk Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

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：

Kowk Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

Institution
hospital：

The Chinese University of Hong Kong

Address：

Kowk Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

经费或物资来源：

Early Career Scheme

Source(s) of funding：

Early Career Scheme

研究疾病：

Intellectual Disabilities  

Target disease：

Intellectual Disabilities

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：

随机平行对照 

Study design：

Parallel 

研究目的：

1. To examine the effects of a 4-month school-based HIIT intervention compared with a conventional continuous-based exercise intervention on physical fitness in adolescents with ID 2. To examine the effects of a 4-month school-based HIIT intervention compared with a conventional continuous-based exercise intervention on cognitive and mental health in adolescents with ID 3. To evaluate the sustainability of the HIIT intervention in adolescents with IDs over a 4-month follow-up period 4. To evaluate the implementation process and intervention elements of the HIIT program that contributed to desirable behavioral changes in adolescents with ID  

Objectives of Study：

1. To examine the effects of a 4-month school-based HIIT intervention compared with a conventional continuous-based exercise intervention on physical fitness in adolescents with ID 2. To examine the effects of a 4-month school-based HIIT intervention compared with a conventional continuous-based exercise intervention on cognitive and mental health in adolescents with ID 3. To evaluate the sustainability of the HIIT intervention in adolescents with IDs over a 4-month follow-up period 4. To evaluate the implementation process and intervention elements of the HIIT program that contributed to desirable behavioral changes in adolescents with ID

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Adolescents aged 12-17 (i.e., Secondary 1-6) with a mild level of ID (i.e., IQ 50-70 as defined by the World Health Organization)

Inclusion criteria

Adolescents aged 12-17 (i.e., Secondary 1-6) with a mild level of ID (i.e., IQ 50-70 as defined by the World Health Organization)

排除标准：

Adolescents with IQ below 50 and/or more than 70.

Exclusion criteria：

Adolescents with IQ below 50 and/or more than 70.

研究实施时间：

Study execute time：

从 From 2026-03-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-03-02 00:00:00 至 To 2026-03-31 00:00:00

干预措施：

Interventions：

组别：

School-based HIIT

样本量：

 60

Group：

School-based HIIT

Sample size：

干预措施：

The HIIT exercise protocol involves students engaging in 12-20 minutes of teacher led HIIT at 85% of the maximum HR three times per week.

干预措施代码：

Intervention：

The HIIT exercise protocol involves students engaging in 12-20 minutes of teacher led HIIT at 85% of the maximum HR three times per week.

Intervention code：

组别：

Continued-based exercise

样本量：

 60

Group：

Continued-based exercise

Sample size：

干预措施：

Perform conventional, continuous-based activities (e.g., jogging, running or cycling) over the 4-month period to serve as comparison

干预措施代码：

Intervention：

Perform conventional, continuous-based activities (e.g., jogging, running or cycling) over the 4-month period to serve as comparison

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)：

 The Chinese University of Hong Kong 

单位级别：

 University 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Cardiovascular fitness

指标类型：

主要指标

Outcome：

Cardiovascular fitness

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Muscular strength

指标类型：

主要指标

Outcome：

Muscular strength

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Functional lower extremity endurance

指标类型：

主要指标

Outcome：

Functional lower extremity endurance

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Anthropometry and body composition

指标类型：

主要指标

Outcome：

Anthropometry and body composition

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Waist circumference

指标类型：

主要指标

Outcome：

Waist circumference

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Executive function

指标类型：

次要指标

Outcome：

Executive 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：

Mental wellbeing

指标类型：

次要指标

Outcome：

Mental wellbeing

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Enjoyment Responses

指标类型：

次要指标

Outcome：

Enjoyment Responses

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Adherence

指标类型：

次要指标

Outcome：

Adherence

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Qualitative Evaluation

指标类型：

附加指标

Outcome：

Qualitative Evaluation

Type：

Additional 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：

无

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

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）：

The allocation ratio of the experimental and active control groups will be set at 1:1. The randomization procedure will be hidden from the investigators, and performed by a staff member who is unaware of the study purpose using an online random number generator (https://www.random.org/).

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

The allocation ratio of the experimental and active control groups will be set at 1:1. The randomization procedure will be hidden from the investigators, and performed by a staff member who is unaware of the study purpose using an online random number generator (https://www.random.org/).

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：

None

Blinding：

None

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）：

None

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

None

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：

CRF

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

CRF

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：

  2026-03-02 11:35:39