ChiCTR2500108626 版本V1.0 版本创建时间2025/09/02 16:49:48 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：

 ChiCTR2500108626 

最近更新日期：

Date of Last Refreshed on：

 2025-09-02 16:49:25 

注册时间：

Date of Registration：

 2025-09-02 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

A Multilevel Implementation Study for Physical Activity Promotion in Children with Disabilities

Public title：

A Multilevel Implementation Study for Physical Activity Promotion in Children with Disabilities

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A Multilevel Implementation Study for Physical Activity Promotion in Children with Disabilities

Scientific title：

A Multilevel Implementation Study for Physical Activity Promotion in Children with Disabilities

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：

Jingsi WEN 

研究负责人：

Prof. Cindy Hui Ping SIT 

Applicant：

Jingsi WEN 

Study leader：

Prof. Cindy Hui Ping SIT 

申请注册联系人电话：

Applicant telephone：

 +852 5497 0397

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：

 wenjs@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, Shatin, NT, Hong Kong SAR

研究负责人通讯地址：

The Chinese University of Hong Kong, Shatin, NT, Hong Kong SAR

Applicant address：

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

Study leader's address：

The Chinese University of Hong Kong, Shatin, NT, Hong Kong SAR

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：

 CRE-2019.471

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：

 2019-10-05 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, NT, Hong Kong SAR

Contact Address of the ethic committee：

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

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：

The Chinese University of Hong Kong, Shatin, NT, Hong Kong SAR

Primary sponsor's address：

The Chinese University of Hong Kong, Shatin, NT, Hong Kong SAR

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：

The Chinese University of Hong Kong, Shatin, NT, Hong Kong SAR

Institution
hospital：

The Chinese University of Hong Kong

Address：

The Chinese University of Hong Kong, Shatin, NT, Hong Kong SAR

经费或物资来源：

The Hong Kong Jockey Club

Source(s) of funding：

The Hong Kong Jockey Club

研究疾病：

Children with disabilities  

Target disease：

Children with 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：

单臂 

Study design：

Single arm 

研究目的：

(1) To promote both physical (e.g., physical activity levels, physical fitness) and psychosocial (e.g., enjoyment, quality of life) health among children with disabilities). (2) To advance professional competence practice of PE teachers and practitioners working with children with disabilities. (3) To enhance knowledge and participation of family on adapted physical activity. (4) To develop an effective and sustainable adapted physical activity model that empowers children with disabilities to become active and healthy in their school and family settings.  

Objectives of Study：

(1) To promote both physical (e.g., physical activity levels, physical fitness) and psychosocial (e.g., enjoyment, quality of life) health among children with disabilities). (2) To advance professional competence practice of PE teachers and practitioners working with children with disabilities. (3) To enhance knowledge and participation of family on adapted physical activity. (4) To develop an effective and sustainable adapted physical activity model that empowers children with disabilities to become active and healthy in their school and family settings.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

A total of 40 local special schools which enroll children with four disability types including vision impairment, hearing impairment, physical disability, and intellectual disability (mild or moderate levels) would be include. The target population was Hong Kong children with vision impairment, hearing impairment, physical disability, and intellectual disability who are at 6-18 years.

Inclusion criteria

A total of 40 local special schools which enroll children with four disability types including vision impairment, hearing impairment, physical disability, and intellectual disability (mild or moderate levels) would be include. The target population was Hong Kong children with vision impairment, hearing impairment, physical disability, and intellectual disability who are at 6-18 years.

排除标准：

Exclusion criteria include medical conditions that limit participation in physical activity.

Exclusion criteria：

Exclusion criteria include medical conditions that limit participation in physical activity.

研究实施时间：

Study execute time：

从 From 2020-01-21 00:00:00至 To 2024-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-01-21 00:00:00 至 To 2023-10-31 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 1200

Group：

Intervention group

Sample size：

干预措施：

In school setting: (1) improvement of physical education, (2) development and delivery of sports programs, (3) promotion of activity breaks, (4) professional development for teachers, (5) resource support. In family setting: (1) parent education, (2) adapted physical activity programs, (3) parent coaching, (4) network building, (5) resources support.

干预措施代码：

Intervention：

In school setting: (1) improvement of physical education, (2) development and delivery of sports programs, (3) promotion of activity breaks, (4) professional development for teachers, (5) resource support. In family setting: (1) parent education, (2) adapted physical activity programs, (3) parent coaching, (4) network building, (5) resources support.

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)：

 Hong Kong 

Country：

China

Province：

Hong Kong

City：

Hong Kong

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：

Physical activity levels

指标类型：

主要指标

Outcome：

Physical activity levels

Type：

Primary indicator

测量时间点：

测量方法：

Actigraph accelerometers and the International Physical Activity Questionnaire

Measure time point of outcome：

Measure method：

Actigraph accelerometers and the International Physical Activity Questionnaire

指标中文名：

Physical fitness

指标类型：

主要指标

Outcome：

Physical fitness

Type：

Primary indicator

测量时间点：

测量方法：

Pacer test, body fat, curl-up, sit-and-reach, handgrip

Measure time point of outcome：

Measure method：

Pacer test, body fat, curl-up, sit-and-reach, handgrip

指标中文名：

Self-concept

指标类型：

主要指标

Outcome：

Self-concept

Type：

Primary indicator

测量时间点：

测量方法：

The Chinese version of the Physical Self-Description Questionnaire Short Form

Measure time point of outcome：

Measure method：

The Chinese version of the Physical Self-Description Questionnaire Short Form

指标中文名：

Cognitive function

指标类型：

主要指标

Outcome：

Cognitive function

Type：

Primary indicator

测量时间点：

测量方法：

Computer-based executive function tasks

Measure time point of outcome：

Measure method：

Computer-based executive function tasks

指标中文名：

Perceived social support

指标类型：

主要指标

Outcome：

Perceived social support

Type：

Primary indicator

测量时间点：

测量方法：

The Chinese version of the Multidimensional Scale of Perceived Social Support

Measure time point of outcome：

Measure method：

The Chinese version of the Multidimensional Scale of Perceived Social Support

指标中文名：

Quality of life

指标类型：

主要指标

Outcome：

Quality of life

Type：

Primary indicator

测量时间点：

测量方法：

The Chinese version of the Pediatric Quality of Life Inventory

Measure time point of outcome：

Measure method：

The Chinese version of the Pediatric Quality of Life Inventory

指标中文名：

Enjoyment

指标类型：

主要指标

Outcome：

Enjoyment

Type：

Primary indicator

测量时间点：

测量方法：

5-point scale with emoji symbols

Measure time point of outcome：

Measure method：

5-point scale with emoji symbols

指标中文名：

Teacher/parent level data

指标类型：

次要指标

Outcome：

Teacher/parent level data

Type：

Secondary indicator

测量时间点：

测量方法：

Focus group interview

Measure time point of outcome：

Measure method：

Focus group interview

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

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 6 岁 years
最大 Max age 18 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）：

None

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

None

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

是Yes

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）：

Data availability The datasets used and/or analysed during the current study are available on reasonable request.

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

Data availability The datasets used and/or analysed during the current study are available on reasonable request.

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：

Data collection is performed using paper-based forms during participant testing to record individual results. These forms are then manually transferred into Excel spreadsheets for data storage and further analysis.

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

Data collection is performed using paper-based forms during participant testing to record individual results. These forms are then manually transferred into Excel spreadsheets for data storage and further analysis.

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：

  2025-09-02 16:49:25