ChiCTR2600123276 版本V1.0 版本创建时间2026/04/23 14:48:57 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:

ChiCTR2600123276 

最近更新日期:

Date of Last Refreshed on:

2026-04-23 14:48:40 

注册时间:

Date of Registration:

2026-04-23 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

不同形式有氧运动对抑郁症状大学生注意偏向的影响及神经生理学机制

Public title:

Effects of different aerobic exercise modalities on attentional bias and its neurophysiological mechanisms 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:

不同形式有氧运动对抑郁症状大学生注意偏向的影响及神经生理学机制

Scientific title:

Effects of different aerobic exercise modalities on attentional bias and its neurophysiological mechanisms 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:

李淑璠 

研究负责人:

张庆文 

Applicant:

Shufan Li 

Study leader:

Qingwen Zhang 

申请注册联系人电话:

Applicant telephone:

+86 133 3634 0636

研究负责人电话:

Study leader's
telephone:

+86 189 1666 0989

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:

lishufan@sus.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

zqw@sus.edu.cn

申请单位网址(自愿提供):

Applicant website(voluntary supply):

上海体育大学

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:

No. 650, Qingyuan Ring Road, Yangpu District, Shanghai, China

Study leader's address:

No. 650, Qingyuan Ring Road, Yangpu District, Shanghai, China

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:

102772025RT188

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 University of Sport

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:

No. 650, Qingyuan Ring Road, Yangpu District, Shanghai, China

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:

No. 650, Qingyuan Ring Road, Yangpu District, Shanghai, China

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:

No. 650, Qingyuan Ring Road, Yangpu District, Shanghai, China

经费或物资来源:

上海体育大学学术型研究生科研经费

Source(s) of funding:

Research Funding for Academic Postgraduates at 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:

探究抑郁症状大学生的静息态脑电特征、注意偏向及ERP特征,探讨体育锻炼、抑郁症状、注意偏向及脑电特异性指标的关系,明晰体育锻炼不同要素和水平的效应,寻找靶点、解决问题的路径和办法。探讨不同形式有氧运动对抑郁症状大学生抑郁症状和注意偏向的影响,验证改善靶点的效果及可能的神经生理学机制。  

Objectives of Study:

To investigate the resting-state EEG characteristics, attentional bias, and ERP features of college students with depressive symptoms, to explore the relationships among physical exercise, depressive symptoms, attentional bias, and specific EEG indicators, to clarify the effects of different components and levels of physical exercise, and to identify targets as well as pathways and methods for solving the problem. Furthermore, to examine the effects of different forms of aerobic exercise on depressive symptoms and attentional bias in college students with depressive symptoms, and to verify the effectiveness of the identified targets and the possible neurophysiological mechanisms underlying these effects.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

在校大学生;年龄18~22周岁;无重大器质性疾病;无精神病史及未服用过精神类药物;无慢性疾病;无运动禁忌症;视力或矫正视力正常,无色盲色弱;右利手;抑郁症状组的贝克抑郁量表得分为14~28分;非抑郁症状组的贝克抑郁量表得分<14分;自愿参与本实验研究。

Inclusion criteria

College students currently enrolled; aged 18 to 22 years old; free from major organic diseases; no history of mental illness and no use of psychiatric medications; free from chronic diseases; no contraindications to exercise; normal or corrected-to-normal vision, no color blindness or color weakness; right-handed; a score of 14 to 28 on the Beck Depression Inventory for the depressive symptoms group; a score of less than 14 on the Beck Depression Inventory for the non-depressive symptoms group; voluntary participation in this experimental study.

排除标准:

运动员或体育专业学生;存在身体不适,近期存在运动损伤等无法参与体育锻炼;当前或近三个月内正在参与其他系统性干预研究;在未来六个月内有手术治疗计划。

Exclusion criteria:

Athletes or students majoring in physical education; individuals experiencing physical discomfort or recent sports injuries that prevent participation in physical exercise; individuals currently participating in or having participated in other systematic intervention studies within the past three months; individuals with plans for surgical treatment within the next six months.

研究实施时间:

Study execute time:

From 2025-11-10 00:00:00 To 2026-11-15 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-11-10 00:00:00 To 2026-05-31 00:00:00

干预措施:

Interventions:

组别:

跑台组

样本量:

25

Group:

treadmill group

Sample size:

干预措施:

热身5分钟,主要锻炼20分钟(持续匀速跑,心率稳定在目标区间),整理放松5分钟,使用意大利Tecnobody数字化跑台。

干预措施代码:

Intervention:

The warm-up lasts 5 minutes, followed by 20 minutes of main exercise (continuous running at a constant speed, with heart rate maintained within the target range), and ends with a 5-minute cool-down and relaxation period. An Italian Tecnobody digital treadmill is used.

Intervention code:

组别:

健美操组

样本量:

25

Group:

Aerobics group

Sample size:

干预措施:

采用第三套《全国健美操大众锻炼标准》成人一级规定动作。热身5分钟,主要锻炼20分钟(完整演练全套动作,每完成一套间歇1分钟,共6套循环),整理放松5分钟。

干预措施代码:

Intervention:

The third set of the "National Aerobics Exercise Standard" adult level one prescribed movements is adopted. The warm-up lasts 5 minutes, followed by 20 minutes of main exercise (performing the complete set of movements in full, with a 1-minute rest after each complete set, for a total of 6 cycles), and ends with a 5-minute cool-down and relaxation period.

Intervention code:

组别:

八段锦组

样本量:

25

Group:

Baduanjin group

Sample size:

干预措施:

按照国家体育总局颁布的“健身气功·八段锦”进行。热身5分钟,主要锻炼20分钟(采用“6分钟竞赛版”节奏演练,每遍间歇1分钟,共3遍),整理放松5分钟。

干预措施代码:

Intervention:

The exercise is performed in accordance with the "Health Qigong·Baduanjin" promulgated by the General Administration of Sport of China. The warm-up lasts 5 minutes, followed by 20 minutes of main exercise (practicing according to the rhythm of the "6-minute competition version," with a 1-minute rest after each round, for a total of 3 rounds), and ends with a 5-minute cool-down and relaxation period.

Intervention code:

组别:

对照组

样本量:

25

Group:

control group

Sample size:

干预措施:

单次对照组静坐30min,长期对照组不进行规律性运动,维持原有生活习惯,研究人员不定期访问。

干预措施代码:

Intervention:

For the acute session, the control group sat quietly for 30 minutes; for the chronic intervention, the control group refrained from regular exercise, maintained their usual lifestyle habits, and were visited irregularly by the researchers for monitoring.

Intervention code:

组别:

观察性研究的抑郁症状组

样本量:

125

Group:

Depressive Symptoms Group in the Observational Study

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

观察性研究的非抑郁症状组

样本量:

125

Group:

Non-depressive Symptoms Group in the Observational Study

Sample size:

干预措施:

干预措施代码:

Intervention:

None

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):

上海外国语大学 

单位级别:

大学 

Institution
hospital:

Shanghai International Studies University

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:

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:

点探测任务及ERP脑电信号

指标类型:

主要指标

Outcome:

dot-probe task and ERP EEG signals

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:

注意偏向量表

指标类型:

主要指标

Outcome:

Attentional Bias Scale

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 22 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):

研究一由本研究团队中不参与被试招募与分组实施的一名统计人员采用计算机随机数字法将抑郁症状大学生分为跑台组、健美操组、八段锦组和对照组

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

A statistician from the research team who is not involved in participant recruitment or group allocation will use a computerized random number method to assign college students with depressive symptoms into four groups: treadmill group, aerobics group, Baduanjin group, and control group.

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:

对测评人员施盲

Blinding:

Outcome assessors were blinded to group allocation

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):

计划于 2026年12月31日前,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):

It is planned that by December 31, 2026, anonymized raw data will be publicly shared through the ResMan Electronic Data Capture (EDC) system via the Clinical Trial Public Management Platform ResMan IPD (http://www.medresman.org.cn).

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:

2名不参与干预的研究人员进行数据采集;所有数据均保存在有密码的计算机中。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 were collected by two researchers who were not involved in the intervention. All data were stored in password-protected computers and uniformly 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:

 2026-04-23 14:48:40