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一举两得——结合认知挑战的基本动作技能干预对幼儿身体素养和执行功能的影响：一项集群随机交叉试验
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注册号：

Registration number：

 ChiCTR2500108295 

最近更新日期：

Date of Last Refreshed on：

 2025-08-27 19:17:44 

注册时间：

Date of Registration：

 2025-08-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一举两得——结合认知挑战的基本动作技能干预对幼儿身体素养和执行功能的影响：一项集群随机交叉试验

Public title：

Filling Two Needs with One Deed——The Effect of Fundamental Movement Skills with Cognitive Challenges on Physical Literacy and Executive Function in Young Children: A Cluster Randomized Crossover Trial

注册题目简写：

一举两得——提升香港学龄前儿童身体素养的“AMPLE”项目

English Acronym：

Filling Two Needs with One Deed——Promoting Physical Literacy among Hong Kong Preschoolers: the "AMPLE" Program

研究课题的正式科学名称：

一举两得——结合认知挑战的基本动作技能干预对幼儿身体素养和执行功能的影响：一项集群随机交叉试验

Scientific title：

Filling Two Needs with One Deed——The Effect of Fundamental Movement Skills with Cognitive Challenges on Physical Literacy and Executive Function in Young Children: A Cluster Randomized Crossover 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：

叶铮 

研究负责人：

沈剑威 

Applicant：

Zheng Ye 

Study leader：

Raymond Kim Wai Sum 

申请注册联系人电话：

Applicant telephone：

 +852 6843 3216

研究负责人电话：

Study leader's
telephone：

+852 3943 6091

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：

 albusye@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 albusye@link.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)：

 https://www.spe.cuhk.edu.hk/eng/people.asp?pageid=16

申请注册联系人通讯地址：

香港特别行政区香港中文大学汾阳体育馆体育运动科学系

研究负责人通讯地址：

香港特别行政区香港中文大学汾阳体育馆体育运动科学系

Applicant address：

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

Study leader's address：

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

香港中文大学体育运动科学系

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：

香港中文大学体育运动科学系

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：

 2024.702-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：

香港中文大学 – 新界东医院联网临床研究伦理联席委员会

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Terrotories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC)

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-02-26 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：

香港特别行政区新界威尔斯亲王医院吕志和临床医学大楼8楼

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Sha Tin, 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：

香港特别行政区研究资助局；香港中文大学

Primary sponsor：

Research Grants Council (RGC) of Hong Kong SAR; The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

香港特别行政区湾仔港湾道6-8号瑞安中心7楼

Primary sponsor's address：

7/F., Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong SAR

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中华人民共和国

省(直辖市)：

香港特别行政区

市(区县)：

香港特别行政区

Country：

China

Province：

Hong Kong

City：

Hong Kong

单位(医院)：

香港中文大学

具体地址：

香港特别行政区新界沙田香港中文大学

Institution
hospital：

The Chinese University of Hong Kong

Address：

The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR

经费或物资来源：

普通研究基金

Source(s) of funding：

General Research Fund

研究疾病：

身体素养促进  

Target disease：

physical literacy promotion

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：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

1. 探讨香港幼儿心肺适能、基本动作技能、体力活动及执行功能的现状。 2. 制定并实施一套有效的以基本动作技能为基础的幼儿身体素养及认知发展干预课程及评估体系，旨在有效提升幼儿的认知水平，培养良好的体能活动习惯，最终达到“一举两得”的目标，为后续的学校学习和终身健康奠定基础。 3. 探讨干预方案对幼儿身体素养和执行功能发展变化的有效性。 4. 丰富香港背景下关于基本动作技能、身体素养、体能活动、执行功能及公共卫生的文献信息。  

Objectives of Study：

1. To explore the current status of cardiorespiratory fitness, fundamental movement skills, physical activity and executive function of young children in Hong Kong. 2. To develop and implement an effective curriculum and assessment system for physical literacy and cognitive development interventions for young children based on fundamental movement skills, which aims to effectively improve young children’s cognitive levels and help develop good physical activity habits, ultimately achieving the goal of "Filling Two Needs with One Deed" and laying the foundation for subsequent school learning and lifelong health. 3. To examine the effectiveness of intervention programs on changes in the development of physical literacy and executive function in young children. 4. To add information to the literature of fundamental movement skills, physical literacy, physical activity, executive function and public health in the Hong Kong context.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1. 旷工率超过20% 2. 参与者年龄超出3-6岁范围。 3. 无法定期上幼儿园的参与者。 4. 已知患有疾病或残疾的参与者，将限制其完成研究干预和评估所需的FMS、体力活动、日常任务或认知任务。 5. 未获得父母或监护人同意的参与者。

Exclusion criteria：

1 The absenteeism rate exceeds 20%; 2 Participant do not participate completely in the pre- and post-intervention assessments; 3 Participant out of the age range of 3-6 years; 4 Participant with known medical conditions or disabilities that would limit their participation in completing the FMS, physical activity, daily tasks, or cognitive tasks required for the study intervention and assessments; 5 Participant without obtaining consent form from their parent or guardian.

研究实施时间：

Study execute time：

从 From 2025-09-01 00:00:00至 To 2027-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-09-01 00:00:00 至 To 2025-10-01 00:00:00

干预措施：

Interventions：

组别：

结合组

样本量：

 198

Group：

Combination Group (FMS with Cognitive Challenge)

Sample size：

干预措施：

教师将在课堂上开展一系列具有认知挑战性的基本动作技能游戏。每场游戏持续20分钟，每周进行3次。以下是一个以跑步作为基本动作技能训练的认知挑战游戏示例：“真实版四子棋”。游戏将放置一个7列6行、1.2米长、1米宽的棋盘，所有参与者站在15米外的一条胶带线后，并设置一个20分钟的计时器。参与者的目标是尽快将他们的4个棋子摆放在大棋盘上，并保持棋子在一条直线上（横线、竖线或对角线均可）。游戏两人一组进行，当一名参与者摆好棋子并跑回胶带线后，另一名参与者即可开始游戏。在整个游戏过程中，所有参与者的心率都将受到监测，以确保他们的心率保持在最大心率的65%至85%之间。

干预措施代码：

 IG1

Intervention：

A series of FMS games with Cognitive Challenges will be implemented by teachers during classroom time. Each game will last 20 minutes and will be played 3 times a week. An example of a game with cognitive challenges using running as FMS training: "connect 4 real version", a board with 7 columns and 6 rows, 1.2 meters long and 1 meter wide, will be placed, with all participants standing behind a taped line 15 meters away and a timer set for 20 minutes. The goal of the participants is to place their 4 game pieces on the large board as quickly as possible and keep the pieces in a straight line (horizontal, vertical, or diagonal lines are all allowed). The game is played in pairs, and once one participant had finished placing the pieces and run back behind the tape line, the other participant is allowed to set off. Throughout the game, all participants will be monitored for heart rate to ensure that their heart rate is maintained within 65% to 85% of their maximum heart rate.

Intervention code：

组别：

认知组

样本量：

 198

Group：

Cognitive Group (Sedentary with Cognitive Challenge)

Sample size：

干预措施：

教师将在课堂时间安排一系列仅针对认知挑战的游戏。每场游戏持续20分钟，每周进行3次。例如，游戏“四子棋常规版”要求所有参与者坐在桌旁，保持静坐状态，并设置20分钟的计时器。游戏的目标是将自己的4个棋子放置在棋盘上，并尝试将它们连成一条直线。游戏以两人一组进行，其中一人放置好棋子后，另一人就可以继续放置。

干预措施代码：

 IG2

Intervention：

A series of games with only cognitive challenges will be implemented by the teachers during classroom time. Each game will last 20 minutes and will be played 3 times a week. Example of the game: "connect 4 routine version", all participants will be seated at a table to ensure a sedentary state and a timer will be set for 20 minutes. The goal of the game is to place 4 of their own game pieces on the board and try to connect the pieces in a straight line. The game is played in pairs, and once one participant has placed his or her piece, the other participant will be allowed to place the piece.

Intervention code：

组别：

运动组

样本量：

 198

Group：

Physical Group (FMS without Cognitive Challenge)

Sample size：

干预措施：

教师将在课堂上开展一系列仅包含基本动作技能干预的游戏。每场游戏持续20分钟，每周进行3次。游戏示例：将放置一张清晰标注回合数的图表，所有参与者将站在15米外的一条胶带线后，并设置一个20分钟的计时器。参与者用完后，需要尽快在图表上标记回合数并返回。返回后，允许下一位参与者开始并重复游戏。在整个游戏过程中，所有参与者的心率都将受到监测，以确保其心率保持在最大心率的65%至85%之间。

干预措施代码：

 IG3

Intervention：

A series of games with FMS intervention only will be implemented by the teachers during classroom time. Each game will last 20 minutes and will be played 3 times a week. Example of the game: a clearly marked chart with rounds will be placed, all participants will stand behind a taped line 15 meters away and a timer will be set for 20 minutes. Once a participant has run out, they need to mark the number of rounds on the chart as soon as possible and return, once they have returned the next participant is allowed to start and repeat. Throughout the game, all participants will be monitored for heart rate to ensure that their heart rate remains within 65% to 85% of their maximum heart rate.

Intervention code：

组别：

控制组

样本量：

 198

Group：

Control Group (Sedentary without Cognitive Challenge)

Sample size：

干预措施：

所有参与者将不会参与任何认知挑战或基本动作技能干预，而是坐在自己的座位上，老师会播放一个20分钟的适合幼儿的故事。所有参与者将在课程开始前被告知，他们不会被问及任何与视频或故事相关的问题，并尽可能保持放松和舒适，以确保他们处于足够低的认知状态。

干预措施代码：

 CG

Intervention：

All participants will not engage in any Cognitive Challenge or FMS interventions but will sit in their own seats while the teacher plays a 20-minute story appropriate for young children. All participants will be informed prior to the start of the program that they will not be asked any questions related to the video or story and can remain as relaxed and comfortable as possible to ensure they are in a low enough cognitive state.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中华人民共和国

省(直辖市)：

 香港特别行政区 

市(区县)：

 香港特别行政区 

Country：

China

Province：

Hong Kong

City：

Hong Kong

单位(医院)：

 香港中文大学 

单位级别：

 大学 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

心肺适能

指标类型：

主要指标

Outcome：

Cardiorespiratory Fitness (CRF)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

pre & post test

Measure method：

20m shuttle-run test PREschoolers FITness assessment (20m SRT-PREFIT )

指标中文名：

基本动作技能

指标类型：

主要指标

Outcome：

Fundamental Movement Skills (FMS)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

pre & post test

Measure method：

Test of Gross Motor Development Third Edition (TGMD-3)

指标中文名：

体力活动

指标类型：

主要指标

Outcome：

Physical Activity (PA)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

pre & post test

Measure method：

Accelerometer (GT3X+, Actigraph, Florida, USA)

指标中文名：

工作记忆

指标类型：

主要指标

Outcome：

Working Memory (WM)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

pre & post test

Measure method：

Word List Recall test (WLR)

指标中文名：

认知灵活性

指标类型：

主要指标

Outcome：

Cognitive Flexibility (CF)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

pre & post test

Measure method：

Conditioned Test B, TRAILS-P tool

指标中文名：

抑制控制

指标类型：

主要指标

Outcome：

Inhibitory Control (IC)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

pre & post test

Measure method：

Conditioned Test C, TRAILS-P tool

指标中文名：

自觉用力程度和自觉脑力用力程度的评分

指标类型：

主要指标

Outcome：

Ratings of Perceived exertion and perceived mental exertion

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

pre & post test

Measure method：

Borg CR-10 scale

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 3 岁 years
最大 Max age 6 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）：

根据香港教育局的数据，2022/2023学年，香港共有1026所幼稚园，分布于香港岛、九龙和新界3个行政区的18个地区。本研究将从每个地区随机选取一所幼稚园作为代表幼稚园，并通过计算机生成的随机序列表（GraphPad Software, Inc.）向幼稚园校长发送电子邮件和邀请函。在校长同意参与后，将以相同的方式为每个幼稚园班级生成随机序列表，并最终确定四个参与班级。

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

According to the Hong Kong Education Bureau, there are 1,026 kindergartens in Hong Kong in the year 2022/2023 in 18 districts in 3 regions of Hong Kong Island, Kowloon, and the New Territories. In this study, one kindergarten will be randomly selected from each district as a representative kindergarten, and an email and invitation letter will be sent to the kindergarten principals through a computer-generated randomized sequential list (GraphPad Software, Inc.). After the principals agreed to participate, a randomized sequential list would be generated in the same manner for each kindergarten class and the four participating classes would be finalized.

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：

参与者（3-6岁幼儿）设盲

Blinding：

Participants (3-6 years old preschoolers) are blinded

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

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）：

本研究获得的数据可能会提供给对幼儿体育素养干预有学术兴趣的合格研究人员。共享的数据或样本将被编码，不包含任何个人健康信息 (PHI)。与请求方共享数据的前提条件是，请求获得批准并签署所有适用协议（例如材料转让协议）。数据请求可在文章发表后 9 个月内提交，数据开放期限最长为 24 个月。数据开放期限的延长将根据具体情况考虑。

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

Data obtained through this study may be provided to qualified researchers with academic interest in physical literacy intervention in young children. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.

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：

本研究高度重视保护参与者的隐私和数据安全。以下是个人数据和研究数据处理和存储方式的详细说明： 研究期间： 知情同意：参与者将被充分告知研究的目的、流程和数据处理规范。参与者将在参与前签署知情同意书。 匿名化：个人数据将使用唯一标识符进行匿名化处理，将参与者的身份与其收集的数据区分开来。 安全数据收集：我们将实施安全的数据收集方法，包括加密以保护传输和存储过程中的数据，并将访问权限限制在授权人员范围内。 研究结束后： 数据保留：数据将在研究完成后保留 5 年，以便将来进行分析或复制。 安全处置：5 年后，个人标识符将被安全处置，确保数据无法与个人关联。 研究期间，只有授权的研究团队成员才能访问个人数据，并且只能用于与研究相关的目的。访问将通过香港中文大学支持的安全登录凭证和加密措施进行限制，以防止未经授权的访问。数据将存储在受密码保护的电子数据库或安全研究设施内上锁的文件柜中。研究结束后，个人数据的访问仍仅限于研究团队，以便根据机构政策和伦理指南进行数据分析、报告和归档。研究团队以外的数据共享或传播将仅以去识别化和汇总的格式进行，以保护参与者的隐私。 研究团队负责妥善保管研究期间和研究结束后收集的所有个人数据。主要研究人员拥有最高级别的数据管理、访问和授权权限。这包括确保存储安全和保密，仅限授权人员访问，以及对数据进行匿名化或假名化以保护参与者的隐私。我们将采取充分的数据安全措施，以防止未经授权的访问或泄露。研究结束后，研究团队将继续根据机构政策和伦理指南的要求，在规定的时间内安全地存储数据。任何发布或共享的数据都将以保护参与者隐私和机密性的方式进行。 在指定的存储期限之后，研究团队将以安全的方式处置个人数据，以确保持续保护参与者的隐私和机密性。这将包括永久删除包含个人信息的电子文件或销毁包含个人信息的实体记录，确保任何可识别信息均被移除或匿名化，以防止个人身份被识别。存储在云端或第三方服务器中的数据将被安全删除或传输至指定的、访问权限受限的数据存储库。与研究相关的文档，例如知情同意书和数据管理计划，将根据机构政策存档一段指定的时间。

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

This research prioritizes the protection of participant privacy and data security. Here's a detailed breakdown of how personal and study data will be handled and stored: During the Study: Informed Consent: Participants will be fully informed about the study's purpose, procedures, and data handling practices. They will provide informed consent before participating. Anonymization: Personal data will be anonymized using unique identifiers, separating participants' identities from their collected data. Secure Data Collection: Secure data collection methods will be implemented, including encryption to protect data during transmission and storage, and access will be restricted to authorized personnel. After the Study: Data Retention: Data will be retained for 5 years after the study's completion to allow for potential future analysis or replication. Secure Disposal: After 5 years, personal identifiers will be securely disposed of, ensuring that data cannot be linked back to individuals. During the study, only authorized members of the research team will have access to personal data, and only for study-related purposes. Access will be restricted through secure login credentials and encryption measures supported by Chinese University of Hong Kong to prevent unauthorized access, and data will be stored in password-protected electronic databases or locked filing cabinets in secure research facilities. After the study, access to the personal data will continue to be restricted to the research team for the purpose of data analysis, reporting, and archiving in accordance with institutional policies and ethical guidelines. Data sharing or dissemination outside of the research team will only be done in a de-identified and aggregated format to protect participant confidentiality. The research team is responsible for the safekeeping of all personal data collected during and after the study. The principal investigator has the highest level of data management, access, and authorization authority. This includes ensuring secure and confidential storage, restricting access to authorized personnel only, and anonymizing or pseudonymizing data to protect participant privacy. Adequate data security measures will be implemented to prevent unauthorized access or breaches. After the study, the research team will continue to store the data securely for a specified period as required by institutional policies and ethical guidelines. Any data that are published or shared will be done so in a manner that protects the privacy and confidentiality of the participants. After the specified storage period, the research team will securely dispose of personal data in a manner that ensures continued protection of participant privacy and confidentiality. This will involve permanently deleting electronic files or destroying physical records containing personal information, ensuring any identifiable information is removed or anonymized to prevent individual identification. Data stored in cloud or third-party servers will be securely deleted or transferred to a designated data repository with restricted access. Documentation related to the study, such as consent forms and data management plans, will be archived for a specified period in accordance with institutional policies.

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：

  2025-08-27 19:17:39
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