ChiCTR2600126918 版本V1.0 版本创建时间2026/06/18 16:48:13 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:

ChiCTR2600126918 

最近更新日期:

Date of Last Refreshed on:

2026-06-18 16:48:07 

注册时间:

Date of Registration:

2026-06-18 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

不同强度运动模式对抑郁症状大学生工作记忆的影响

Public title:

Effects of Different Intensity Exercise Modes on Working Memory 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:

不同强度运动模式对抑郁症状大学生工作记忆的影响

Scientific title:

Effects of Different Intensity Exercise Modes on Working Memory 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:

郭昭晖 

研究负责人:

王兴 

Applicant:

GuoZhaoHui  

Study leader:

WangXing  

申请注册联系人电话:

Applicant telephone:

+86 185 6925 5819

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:

Guozhaohui1113@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:

中国上海市杨浦区清源环路650号

研究负责人通讯地址:

中国上海市杨浦区清源环路650号

Applicant address:

650 Qingyuanhuan Road, Yangpu District, Shanghai, China

Study leader's address:

650 Qingyuanhuan 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:

上海体育大学体育教育学院

Applicant's institution:

School of Physical Education, Shanghai University of Sport

研究负责人所在单位:

上海体育大学体育教育学院

Affiliation of the Leader:

School of Physical Education, Shanghai University of Sport

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:

102772025RT173

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:

Ethics Committee for Scientific Research, 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:

ChengRong

伦理委员会联系地址:

中国上海市杨浦区清源环路650号

Contact Address of the ethic committee:

650 Qingyuanhuan Road, Yangpu District, Shanghai, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 21 6550 8179

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

研究实施负责(组长)单位地址:

中国上海市杨浦区清源环路650号

Primary sponsor's address:

650 Qingyuanhuan 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:

中国上海市杨浦区清源环路650号

Institution
hospital:

Shanghai University of Sport

Address:

650 Qingyuanhuan Road, Yangpu District, Shanghai, China

经费或物资来源:

上海体育大学学术型博士研究生科研经费

Source(s) of funding:

Research Funds for Academic Master's Students at Shanghai Sport University

Target disease:

Depressive symptoms lead to a decline in working memory among college students.

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:

探讨并比较高强度间歇运动(HIIT)与中等强度持续运动(MICT)对存在抑郁症状大学生的工作记忆的改善效果,为制定针对该群体的非药物干预方案提供科学依据。  

Objectives of Study:

To explore and compare the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on the working memory of college students with depressive symptoms, and to provide scientific basis for formulating non-pharmacological intervention plans for this group.

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.年龄 >= 18 岁且 <= 25 岁; 2.非体育专业本科生; 3.贝克抑郁量表-II(BDI-II)测试得分 > 13 分; 4.无精神病史及其他慢性疾病; 5.双眼视力或矫正视力正常,无色盲或色弱; 6.右利手; 7.自愿参与本研究并签署知情同意书。

Inclusion criteria

1.Age >= 18 and <= 25 years; 2.Undergraduate students of non-sports majors; 3.Beck Depression Inventory-II (BDI-II) score > 13; 4.No history of psychiatric disorders or other chronic diseases; 5.Normal or corrected-to-normal binocular vision, with no color blindness or color weakness; 6.Right-handedness; 7.Voluntarily participate in this study and sign the informed consent form.

排除标准:

1.被诊断患有其他严重精神或心理疾病(如双相情感障碍、精神分裂症等); 2.目前正在接受精神/心理相关药物治疗,或正参与其他运动干预项目; 3.患有妨碍长期体育锻炼的慢性疾病或严重运动损伤(如骨骼或关节疾病等); 4.无法按计划依从并完成体育锻炼干预训练; 5.具备 > 1 年的长期规律锻炼经历; 6.目前正参与其他可能影响本研究结果的实验项目。

Exclusion criteria:

1.Diagnosed with other severe psychiatric or psychological disorders (e.g., bipolar disorder or schizophrenia); 2.Currently receiving pharmacological treatment or participating in other exercise intervention programs; 3.Suffering from chronic diseases or severe sports injuries (e.g., bone or joint diseases) that prevent long-term physical exercise; 4.Unable to comply with and participate in the scheduled exercise intervention training; 5.Having a history of long-term regular exercise > 1 year; 6.Currently participating in other experimental projects that may affect the study results.

研究实施时间:

Study execute time:

From 2025-12-15 00:00:00 To 2026-12-15 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-07-01 00:00:00 To 2026-12-15 00:00:00  

干预措施:

Interventions:

组别:

高强度间歇组

样本量:

25

Group:

High-intensity interval group

Sample size:

干预措施:

采用跑台进行高强度间歇训练。干预频率为每周 3 次,持续干预 8 周。单次运动时长为 20 分钟,具体为:2 分钟高强度快跑(目标心率需 >= 85% 且 <= 95% HRmax)与 3 分钟低强度快走(目标心率需 >= 50% 且 <= 60% HRmax)交替为 1 组,每次要求完成 4 组。

干预措施代码:

Intervention:

High-intensity interval training on a treadmill. The intervention is performed 3 times per week for a total of 8 weeks. Each session lasts 20 minutes, specifically: 2 minutes of high-intensity running (target heart rate >= 85% and <= 95% HRmax) followed by 3 minutes of low-intensity brisk walking (target heart rate >= 50% and <= 60% HRmax) constitute one set, with 4 sets completed per session.

Intervention code:

组别:

中强度持续组

样本量:

25

Group:

Moderate-intensity continuous group

Sample size:

干预措施:

采用跑台进行中等强度持续训练。干预频率为每周 3 次,持续干预 8 周。每次维持 20 分钟的中等强度持续跑台运动,运动期间目标心率需 >= 64% 且 <= 76% HRmax。

干预措施代码:

Intervention:

Moderate-intensity continuous training on a treadmill. The intervention is performed 3 times per week for a total of 8 weeks. Perform a continuous moderate-intensity treadmill exercise for 20 minutes per session, maintaining a target heart rate >= 64% and <= 76% HRmax during the exercise.

Intervention code:

组别:

对照组

样本量:

25

Group:

Control group

Sample size:

干预措施:

在 8 周的研究期间内,保持个人正常的学习和生活习惯,不参与任何规律性的额外体育锻炼计划。

干预措施代码:

Intervention:

During the 8-week study period, maintain normal study and living habits, and do not participate in any regular additional exercise programs.

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):

上海体育大学 

单位级别:

大学 

Institution
hospital:

Shanghai University of Sport

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

工作记忆

指标类型:

主要指标

Outcome:

Working memory

Type:

Primary indicator

测量时间点:

基线(干预前)、干预第8周(干预后)

测量方法:

N-back 任务范式(1-back 和 2-back)

Measure time point of outcome:

Baseline (pre-intervention), Week 8 (post-intervention)

Measure method:

N-back task paradigm (1-back and 2-back)

指标中文名:

脑电图(EEG)功率值

指标类型:

主要指标

Outcome:

Electroencephalogram (EEG) power

Type:

Primary indicator

测量时间点:

基线(干预前)、干预第8周(干预后)

测量方法:

脑电图(EEG)设备采集

Measure time point of outcome:

Baseline (pre-intervention), Week 8 (post-intervention)

Measure method:

Electroencephalogram (EEG) recording

指标中文名:

事件相关电位(P300波幅、潜伏期)

指标类型:

主要指标

Outcome:

Event-Related Potentials (P300 amplitude and latency)

Type:

Primary indicator

测量时间点:

基线(干预前)、干预第8周(干预后)

测量方法:

脑电图(EEG)设备采集并在认知任务中提取

Measure time point of outcome:

Baseline (pre-intervention), Week 8 (post-intervention)

Measure method:

Extracted from Electroencephalogram (EEG) recording during cognitive tasks

指标中文名:

抑郁症状

指标类型:

主要指标

Outcome:

Depressive Symptoms

Type:

Primary indicator

测量时间点:

基线(干预前)、干预第8周(干预后)

测量方法:

贝克抑郁量表(BDI-II)

Measure time point of outcome:

Baseline (pre-intervention), Week 8 (post-intervention)

Measure method:

Beck Depression Inventory-II (BDI-II)

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

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 18 years
最大 Max age 25 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):

随机序列产生方法:随机分配序列使用统计软件产生随机数字,将合格的研究对象按纳入的顺序编号

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

Random sequence generation method: Randomly assign sequences using statistical software to generate random numbers, and number qualified research subjects in the order they are included

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:

本研究主要采用单盲形式。由于运动干预的特殊性质,受试者和运动干预实施者无法被盲法覆盖。但是负责进行认知功能(工作记忆)评估、EEG/ERP电生理数据采集以及后续数据统计分析的研究人员,将对受试者的具体分组情况完全保持盲态。

Blinding:

Single-blind (Assessor-blinded). Due to the nature of the exercise intervention, participants and intervention providers cannot be blinded. However, the researchers responsible for conducting cognitive function (working memory) assessments, EEG/ERP electrophysiological data collection, and statistical data analysis will remain strictly blinded to the participants' group allocations.

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

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):

原始数据将通过ResMan电子数据采集与管理系统(EDC)的临床试验公共管理平台ResMan IPD(http://www.medresman.org.cn)进行公开共享。预计共享时间为研究结束后6个月内。

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

Raw data will be publicly shared via the clinical trial public management platform ResMan IPD (http://www.medresman.org.cn) of the ResMan Electronic Data Capture (EDC) system. The expected sharing time is within 6 months after the completion of the study.

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独立进行数据采集;所有数据均保存在有密码保护的计算机中,并由ResMan电子数据采集与管理系统(EDC)统一管理。

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

Two independent researchers not involved in the intervention will conduct data collection; all data will be stored on 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:

 2026-06-18 16:48:07