ChiCTR2600124903 版本V1.0 版本创建时间2026/05/19 10:24:28 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:

ChiCTR2600124903 

最近更新日期:

Date of Last Refreshed on:

2026-05-19 10:24:09 

注册时间:

Date of Registration:

2026-05-19 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

单次不同强度运动对抑郁症状大学生抑制功能、脑功能连接及微状态的影响

Public title:

The Effects of Single Exercise of Different Intensities on Inhibitory Function, Brain Functional Connectivity and Microstates in College Students with Depressive Symptoms

注册题目简写:

English Acronym:

研究课题的正式科学名称:

单次不同强度运动对抑郁症状大学生抑制功能、脑功能连接及微状态的影响

Scientific title:

The Effects of Single Exercise of Different Intensities on Inhibitory Function, Brain Functional Connectivity and Microstates in College Students with Depressive Symptoms

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:

任宇希 

研究负责人:

王兴 

Applicant:

Ren Yuxi  

Study leader:

Wang Xing 

申请注册联系人电话:

Applicant telephone:

+86 138 7056 2942

研究负责人电话:

Study leader's
telephone:

+86 186 2161 9513

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:

13870562942@163.com

研究负责人电子邮件:

Study leader's E-mail:

wangxing1933@sus.edu.cn

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:

上海市杨浦区清源环路650号

研究负责人通讯地址:

上海市杨浦区清源环路650号

Applicant address:

650 Qingyuan Ring Road, Yangpu District, Shanghai

Study leader's address:

650 Qingyuan Ring Road, Yangpu District, Shanghai

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:

上海体育大学

Applicant's institution:

Shanghai university of sport

研究负责人所在单位:

上海体育大学

Affiliation of the Leader:

Shanghai university of sport

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

102772025RT174

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:

上海体育大学科学研究伦理委员会

Name of the ethic committee:

Scientific Research Ethics Committee of Shanghai Sport University

伦理委员会批准日期:

Date of approved by ethic committee:

2025-10-15 00:00:00

伦理委员会联系人:

程蓉

Contact Name of the ethic committee:

Rong Cheng

伦理委员会联系地址:

上海市杨浦区清源环路650号

Contact Address of the ethic committee:

650 Qingyuan Ring Road, Yangpu District, Shanghai

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 21 6550 8161

伦理委员会联系人邮箱:

Contact email of the ethic committee:

lunli@sus.edu.cn

研究实施负责(组长)单位:

上海体育大学

Primary sponsor:

Shanghai university of sport

研究实施负责(组长)单位地址:

上海市杨浦区清源环路650号

Primary sponsor's address:

650 Qingyuan Ring Road, Yangpu District, Shanghai

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海体育大学

具体地址:

上海市杨浦区清源环路650号

Institution
hospital:

Shanghai University of Sport

Address:

650 Qingyuan Ring Road, Yangpu District, Shanghai

经费或物资来源:

上海体育大学研究生科研经费

Source(s) of funding:

Postgraduate research funds of Shanghai University of Sport

研究疾病:

抑郁症状  

Target disease:

depressive symptom

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、探究抑郁大学生群体在身体素质、体育锻炼习惯、抑制功能、动态与静态脑电活动表现及其相互关系,以期为改善其抑郁症状提供潜在路径; 2、考察不同强度跳绳运动对抑郁症状大学生即刻情绪、抑制功能、动态与静态脑电活动表现的即时影响;  

Objectives of Study:

1. To explore the physical fitness, sports exercise habits, inhibitory function, dynamic and static electroencephalogram (EEG) activity performance and their interrelationships in the group of college students with depression, with the aim of providing potential pathways for improving their depressive symptoms. 2. To investigate the immediate effects of rope skipping exercises of different intensities on the immediate mood, inhibitory function, dynamic and static EEG activity performance of college students with depressive symptoms.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

招募在校大学生,年龄限定在18至26岁之间,且均为右利手。所有参与者需具备正常的色觉功能,无色盲或色弱。健康状况方面,排除患有严重心血管、肺脏及代谢性疾病者,同时要求无任何运动禁忌症。

Inclusion criteria

We are recruiting college students aged between 18 and 26, all of whom are right-handed. All participants must have normal color vision and no color blindness or color weakness. In terms of health, those with severe cardiovascular, pulmonary or metabolic diseases, as well as any contraindications to exercise, are excluded.

排除标准:

1.年龄<18岁; 2.长期进行药物治疗,呼吸功能障碍,严重肌肉骨骼疾病者; 3.长期进行规律性体育锻炼(每周不低于3次,每次锻炼时间不低于30min,持续1年以上)

Exclusion criteria:

1. Age less than 18 years old; 2. Those who have received long-term medication treatment, have respiratory dysfunction, and suffer from severe musculoskeletal diseases; 3. Those who have engaged in regular physical exercise for a long time (at least 3 times per week, each session lasting no less than 30 minutes, for more than 1 year)

研究实施时间:

Study execute time:

From 2025-11-20 00:00:00 To 2026-11-20 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-11-25 00:00:00 To 2025-12-25 00:00:00

干预措施:

Interventions:

组别:

低强度组

样本量:

25

Group:

low-intensity group

Sample size:

干预措施:

低强度组首先进行5分钟热身,热身即将结束时达到低强度靶心率57%-64%HRmax,并持续20分钟监控运动,最后进行低于靶心率的5分钟整理运动。

干预措施代码:

Intervention:

The low-intensity group first performed a 5-minute warm-up, and at the end of the warm-up, the low-intensity target heart rate was 57%-64%HRmax, and the monitoring exercise lasted for 20 minutes. Finally, the low-intensity group performed a 5-minute finishing exercise below the target heart rate.

Intervention code:

组别:

中强度组

样本量:

25

Group:

moderate intensity group

Sample size:

干预措施:

中强度组首先进行5分钟热身,热身即将结束时达到中等强度靶心率65%-76%HRmax,并持续20分钟监控运动,最后进行低于靶心率的5分钟整理运动。

干预措施代码:

Intervention:

The moderate intensity group performed a 5-minute warm-up, and at the end of the warm-up, the moderate intensity target heart rate of 65%-76%HRmax was reached, and the monitoring exercise lasted for 20 minutes. Finally, the group performed a 5-minute finishing exercise below the target heart rate.

Intervention code:

组别:

高强度组

样本量:

25

Group:

high-intensity group

Sample size:

干预措施:

高强度组首先进行5分钟热身,热身即将结束时达到高强度靶心率77%-95%HRmax持续20分钟,最后进行低于靶心率的5分钟整理运动。

干预措施代码:

Intervention:

The high-intensity group first performed a 5-minute warm-up, and at the end of the warm-up, the high-intensity target heart rate 77%-95%HRmax lasted for 20 minutes and finally performed a 5-minute warm-up exercise below the target heart rate.

Intervention code:

组别:

对照组

样本量:

25

Group:

control group

Sample size:

干预措施:

静坐30分钟

干预措施代码:

Intervention:

Sit still for 30 minutes

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

上海 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

上海对外经贸大学 

单位级别:

大学 

Institution
hospital:

Shanghai University of International Business and Economics

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

贝克抑郁自评量表第二版

指标类型:

主要指标

Outcome:

Beck Depression Inventory-Second Edition (BDI-II)

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁形容词检查表

指标类型:

主要指标

Outcome:

Depression Adjective Check List

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

静息态脑电测试

指标类型:

主要指标

Outcome:

Resting-state electroencephalography recording

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Go-Nogo任务

指标类型:

主要指标

Outcome:

Go-Nogo task

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Stroop任务

指标类型:

主要指标

Outcome:

Stroop task

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

事件相关电位

指标类型:

主要指标

Outcome:

Event-Related Potentials

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:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 26 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):

采用分层随机,由一名独立的研究人员通过网站获取随机序列,采用1:1:1:1的分配比例进行随机区组划分,将研究对象分为低强度、中强度、高强度和对照组。该名研究人员不参与干预的实施和结果的测量。

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

Stratified randomization was used, with an independent researcher obtaining the randomized sequence through a website and randomizing the zones using a 1:1:1:1 allocation ratio, dividing the study population into low-intensity, moderate-intensity, high-intensity, and control groups. The researcher was not involved in the implementation of the intervention or the measurement of outcomes.

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:

评估者施盲

Blinding:

Outcome assessors will be blinded

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):

由 ResMan电子采集和管理系统(Electronic Data Capture, EDC) 通过临床试验公共管理平台ResMan IPD(http://www.medresman.org.cn)公开共享匿名化原始数据。

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

Anonymized raw data is publicly shared via the ResMan Electronic Data Capture (EDC) system through the ResMan http://www.medresman.org.cn (IPD) platform.

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:

通过线上和线下两种方式收集数据,并将所得数据存储于设有密码保护的电脑中。由ResMan电子采集和管理系统(Electronic Data Capture, EDC)统一管理。

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

Data is collected through both online and offline channels and stored on password-protected computers. It is centrally managed by the ResMan Electronic Data Capture (EDC) system.

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:

 2026-05-19 10:24:09