ChiCTR2500103959 版本V1.1 版本创建时间2025/06/09 15:17:23 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:

ChiCTR2500103959 

最近更新日期:

Date of Last Refreshed on:

2025-06-09 15:16:17 

注册时间:

Date of Registration:

2025-06-09 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

短时有氧运动对大学生抑制控制和数学认知的影响——一项近红外光谱研究

Public title:

Can Exercise Improve Math and Brain Performance ? A Study with College Students

注册题目简写:

English Acronym:

研究课题的正式科学名称:

短时有氧运动对大学生抑制控制和数学认知的影响——一项近红外光谱研究

Scientific title:

Effects of Acute Aerobic Exercise on Inhibitory Control and Mathematical Cognition in College Students—A fNIRS Study

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:

黎金明 

研究负责人:

邹立业 

Applicant:

Li Jinming 

Study leader:

Zou Liye 

申请注册联系人电话:

Applicant telephone:

+86 188 1398 2167

研究负责人电话:

Study leader's telephone:

+86 188 2343 7684

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:

Jinmingli1999@gmail.com

研究负责人电子邮件:

Study leader's E-mail:

liyezou123@gmail.com

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:

广东省深圳市南山区南海大道3688号

研究负责人通讯地址:

广东省深圳市南山区南海大道3688号

Applicant address:

3688 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong

Study leader's address:

3688 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong

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:

深圳大学

Applicant's institution:

Shenzhen University

研究负责人所在单位:

深圳大学

Affiliation of the Leader:

Shenzhen University

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:

SZU_PSY_2024_171

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:

深圳大学心理学院研究伦理委员会

Name of the ethic committee:

Human Research Ethics Committee for Non-Clinical Faculties,THE SCHOOL OF PSYCHOLOGY, SHENZHEN UNIVERSITY

伦理委员会批准日期:

Date of approved by ethic committee:

2025-01-09 00:00:00

伦理委员会联系人:

陈琦

Contact Name of the ethic committee:

Cheng Qi

伦理委员会联系地址:

广东省深圳市南山区深圳大学沧海校区智理楼C-L3-12

Contact Address of the ethic committee:

School of Psychology, No. C-L3-12, Building Zhiyi, Caohai Campus, Shenzhen University, Nanshan District, Shenzhen City, Guangdong Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 755 2691 7503

伦理委员会联系人邮箱:

Contact email of the ethic committee:

psych@szu.edu.cn

研究实施负责(组长)单位:

深圳大学

Primary sponsor:

Shenzhen university

研究实施负责(组长)单位地址:

广东省深圳市南山区南海大道3688号

Primary sponsor's address:

3688 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

深圳大学

具体地址:

南山区南海大道3688号

Institution
hospital:

Shenzhen university

Address:

3688 Nanhai Avenue, Nanshan District,

经费或物资来源:

深圳大学卓越研究计划

Source(s) of funding:

Shenzhen University's Outstanding Research Program

Target disease:

None

Target disease code:

研究类型:

干预性研究

Study type:

Interventional study

研究所处阶段:

探索性研究/预试验 

Study phase:

0

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

探索不同运动强度对数学能力和执行功能的影响  

Objectives of Study:

Explore the effects of different exercise intensities on mathematical abilities and executive functions

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. 18至30岁; 2. 无骨科、神经系统、内分泌、心血管及精神疾病。

Inclusion criteria

1. Aged 18 to 30 years; 2. No orthopedic, nervous system, endocrine, cardiovascular and psychiatric diseases.

排除标准:

1. 急性或慢性疾病; 2. 在过去六个月内做过手术; 3. 有吸烟、饮酒的习惯; 4. 一个月内服用过药物; 5. 运动禁忌症

Exclusion criteria:

1. Acute or chronic diseases; 2. Have done any surgery in the past six months; 3. Have the habit of smoking and drinking; 4. Have taken any medicine within one month; 5. There are contraindications to exercise.

研究实施时间:

Study execute time:

From 2025-06-20 00:00:00 To 2026-02-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-06-20 00:00:00 To 2026-02-01 00:00:00  

干预措施:

Interventions:

组别:

实验组1

样本量:

40

Group:

Experimental group1

Sample size:

干预措施:

保持久坐110分钟

干预措施代码:

Intervention:

stay seated for 110 minutes

Intervention code:

组别:

实验组2

样本量:

40

Group:

Experimental group2

Sample size:

干预措施:

20分钟中强度骑车,然后保持久坐90分钟

干预措施代码:

Intervention:

20-minute moderate-intensity cycling followed by 90 minutes of seated rest

Intervention code:

组别:

实验组3

样本量:

40

Group:

Experimental group3

Sample size:

干预措施:

20分钟高强度骑车,然后保持久坐90分钟

干预措施代码:

Intervention:

20-minute high-intensity cycling followed by 90 minutes of seated rest

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

深圳大学 

单位级别:

大学 

Institution
hospital:

Shenzhen University

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

最大摄氧量

指标类型:

次要指标

Outcome:

maximal oxygen uptake

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

执行功能

指标类型:

主要指标

Outcome:

executive function

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

数学能力

指标类型:

主要指标

Outcome:

Math ability

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

大脑激活

指标类型:

主要指标

Outcome:

Brain Activation

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:

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 30 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):

随机交叉试验。实验人员在深圳大学随机招募符合要求的120名受试者。实验开始前,受试者从纸盒中取出纸条,随机抽取1条,分为3组。

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

Randomized crossover trial. The experimenters randomly recruited 120 subjects meeting the requirements in Shenzhen University. Before the experiment, the subjects extracted strips from the carton, and one was randomly selected and assigned to the subjects in 3 groups.

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:

单盲

Blinding:

Single Blinding

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

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):

原始数据可向实验者索取

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

The original data can be requested from the experimenter

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:

数据由人工收集和记录,并输入Stata进行管理

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

The data were collected and recorded manually and input into Stata for management

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:

 2025-06-09 15:16:11