ChiCTR2600127010 版本V1.0 版本创建时间2026/06/22 20:21:08 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：

ChiCTR2600127010 

最近更新日期：

Date of Last Refreshed on：

2026-06-22 20:21:01 

注册时间：

Date of Registration：

2026-06-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

6周足球专项脑耐力训练对大学生足球运动员心理疲劳状态下技术表现、认知功能和重复冲刺能力的影响：一项随机对照试验

Public title：

Effects of 6-week soccer-specific brain endurance training on technical performance, cognitive function, and repeated-sprint ability under mental fatigue in collegiate soccer players: a randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

6周足球专项脑耐力训练对大学生足球运动员心理疲劳状态下技术表现、认知功能和重复冲刺能力的影响：一项随机对照试验

Scientific title：

Effects of 6-week soccer-specific brain endurance training on technical performance, cognitive function, and repeated-sprint ability under mental fatigue in collegiate soccer players: a randomized controlled 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：

王昊宇 

研究负责人：

王昊宇 

Applicant：

Wang Haoyu 

Study leader：

Wang Haoyu 

申请注册联系人电话：

Applicant telephone：

+86 181 0538 8875

研究负责人电话：

Study leader's telephone：

+86 181 0538 8875

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：

why@sdfmu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

why@sdfmu.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：

山东省济南市槐荫区青岛路 6699 号

研究负责人通讯地址：

山东省济南市槐荫区青岛路 6699 号

Applicant address：

No. 6699 Qingdao Road, Jinan, Shandong, China

Study leader's address：

No. 6699 Qingdao Road, Jinan, Shandong, 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：

山东第一医科大学

Applicant's institution：

Shandong First Medical University

研究负责人所在单位：

山东第一医科大学

Affiliation of the Leader：

Shandong First Medical 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：

伦研批第(R202606110378)

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：

山东第一医科大学伦理审查委员会

Name of the ethic committee：

Shandong First Medical University Ethics Review Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2026-06-15 00:00:00

伦理委员会联系人：

王蕾

Contact Name of the ethic committee：

Wang Lei

伦理委员会联系地址：

山东省济南市槐荫区青岛路 6699 号勤笃楼309

Contact Address of the ethic committee：

Room 309, Qindu Building, No. 6699 Qingdao Road, Huaiyin District, Jinan, Shandong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 531 5955 6820

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：

山东第一医科大学

Primary sponsor：

Shandong First Medical University

研究实施负责（组长）单位地址：

山东省济南市槐荫区青岛路 6699 号

Primary sponsor's address：

No. 6699 Qingdao Road, Jinan, Shandong, 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)：

山东

市(区县)：

Country：

China

Province：

Shandong

City：

单位(医院)：

山东第一医科大学

具体地址：

山东省济南市槐荫区青岛路 6699 号

Institution
hospital：

Shandong First Medical University

Address：

No. 6699 Qingdao Road, Jinan, Shandong, China

经费或物资来源：

个人自筹

Source(s) of funding：

Self-funded

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：

 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6周足球专项脑耐力训练是否能提高大学生足球运动员在心理疲劳状态下的：足球专项技术表现（传球、射门）、认知功能（PVT反应时、Stroop任务表现）、重复冲刺能力  

Objectives of Study：

Exploring whether 6 weeks of football-specific brain endurance training can improve university football players' performance under mental fatigue in: football-specific technical performance (passing, shooting), cognitive function (PVT reaction time, Stroop task performance), and repeated sprint ability.

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. 男性，年龄18–24岁； 2. 至少2年以上系统足球训练经历； 3. 每周足球训练不少于3次； 4. 近3个月无严重下肢损伤，能够完成冲刺和变向测试； 5. 自愿签署知情同意书。

Inclusion criteria

1. Male, aged 18–24 years; 2. At least 2 years of systematic football training experience; 3. Participating in football training no less than 3 times per week; 4. No severe lower-limb injuries in the past 3 months, and able to complete sprint and change-of-direction tests; 5. Voluntarily provide written informed consent.

排除标准：

1. 神经系统疾病、严重视觉障碍； 2. 近6个月内脑震荡史； 3. 熟悉测试中Stroop任务准确率低于70%； 4. 实验期间参加额外认知训练或特殊体能干预。

Exclusion criteria：

1. Presence of neurological disorders or severe visual impairments; 2. History of concussion within the past 6 months; 3. Accuracy below 70% on the Stroop task during familiarization testing; 4. Participation in additional cognitive training or specialized physical interventions during the experimental period.

研究实施时间：

Study execute time：

从 From 2026-06-25 00:00:00至 To 2026-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-06-25 00:00:00 至 To 2026-07-01 00:00:00  

干预措施：

Interventions：

组别：

BET组

样本量：

20

Group：

BET Group

Sample size：

干预措施：

BET组接受常规足球训练，并在训练模块之间穿插高认知负荷任务。干预周期为6周，每周3次，共18次。每次训练中完成4组认知任务，每组约4分钟，总认知任务时间约16分钟。认知任务包括Go/No-Go、Flanker、2-back和AX-CPT/Stroop变式，任务难度每2周逐步增加。

干预措施代码：

 BET

Intervention：

The BET group will receive regular soccer training combined with high-cognitive-load tasks inserted between training modules. The intervention will last 6 weeks, with 3 sessions per week, for a total of 18 sessions. During each session, participants will complete four cognitive-task blocks, approximately 4 minutes each, with a total cognitive-task duration of about 16 minutes. The tasks will include Go/No-Go, Flanker, 2-back, and AX-CPT/Stroop variants, with task difficulty progressively increased every 2 weeks.

Intervention code：

组别：

对照组

样本量：

20

Group：

Control Group

Sample size：

干预措施：

对照组接受与BET组相同的常规足球训练，并在相同时间段完成低认知负荷点击任务，任务时长与BET组一致，不接受高认知负荷训练。

干预措施代码：

 CON

Intervention：

The control group will receive the same regular soccer training as the BET group and will complete a duration-matched low-cognitive-load clicking task during the corresponding intervals. No high-cognitive-load training will be provided.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

  

Country：

China 

Province：

Shandong 

City：

 

单位(医院)：

山东第一医科大学 

单位级别：

大学 

Institution
hospital：

Shandong First Medical University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

心理疲劳状态下Loughborough足球传球测试完成时间

指标类型：

主要指标

Outcome：

Loughborough Soccer Passing Test completion time under mental fatigue

Type：

Primary indicator

测量时间点：

基线和6周干预后

测量方法：

30分钟Stroop任务诱导心理疲劳后，进行Loughborough足球传球测试，记录测试完成时间及处罚后的总表现时间，单位为秒。

Measure time point of outcome：

Testing was conducted at baseline and upon completion of the 6-week intervention.

Measure method：

Following the induction of mental fatigue via a 30-minute Stroop task, participants completed the Loughborough Soccer Passing Test (LSPT). The completion time and the total performance time after penalties were recorded, both in seconds.

指标中文名：

Loughborough足球传球测试处罚时间

指标类型：

次要指标

Outcome：

Loughborough Soccer Passing Test penalty time

Type：

Secondary indicator

测量时间点：

基线和6周干预后

测量方法：

根据Loughborough足球传球测试标准流程记录传球错误产生的处罚时间，单位为秒。

Measure time point of outcome：

Testing was conducted at baseline and upon completion of the 6-week intervention.

Measure method：

Penalty time resulting from passing errors was recorded in seconds, following the standardized protocol of the Loughborough Soccer Passing Test (LSPT).

指标中文名：

Loughborough足球射门测试得分

指标类型：

次要指标

Outcome：

Loughborough Soccer Shooting Test score

Type：

Secondary indicator

测量时间点：

基线和6周干预后

测量方法：

采用Loughborough足球射门测试评价射门表现，根据射门准确性和目标区域得分记录总分。

Measure time point of outcome：

Testing was conducted at baseline and upon completion of the 6-week intervention.

Measure method：

Shooting performance was assessed using the Loughborough Soccer Shooting Test (LSST). The total score was calculated according to shooting accuracy and the points assigned to each target area.

指标中文名：

PVT平均反应时

指标类型：

次要指标

Outcome：

Mean reaction time in the Psychomotor Vigilance Test

Type：

Secondary indicator

测量时间点：

基线和6周干预后；Stroop疲劳诱导前后

测量方法：

采用3分钟PVT测试评价警觉性，记录平均反应时，单位为毫秒。

Measure time point of outcome：

Measurements were obtained at baseline and after the 6-week intervention, as well as before and after the Stroop fatigue induction protocol.

Measure method：

Vigilance was assessed using a 3-minute Psychomotor Vigilance Task (PVT). The mean reaction time (in milliseconds) was recorded as the primary outcome measure.

指标中文名：

Stroop任务正确率

指标类型：

次要指标

Outcome：

Accuracy in the Stroop task

Type：

Secondary indicator

测量时间点：

基线和6周干预后

测量方法：

采用计算机化Stroop任务评价抑制控制和抗干扰能力，记录正确反应百分比。

Measure time point of outcome：

Testing was conducted at baseline and upon completion of the 6-week intervention.

Measure method：

Inhibitory control and interference resistance were assessed using a computerized Stroop task. The percentage of correct responses was recorded as the primary performance indicator.

指标中文名：

Stroop任务平均反应时

指标类型：

次要指标

Outcome：

Mean reaction time in the Stroop task

Type：

Secondary indicator

测量时间点：

基线和6周干预后

测量方法：

记录Stroop任务中正确反应试次的平均反应时，单位为毫秒。

Measure time point of outcome：

Testing was conducted at baseline and upon completion of the 6-week intervention.

Measure method：

For the Stroop task, the mean reaction time of correct response trials was recorded, with values expressed in milliseconds (ms).

指标中文名：

重复冲刺平均时间

指标类型：

次要指标

Outcome：

Mean repeated-sprint time

Type：

Secondary indicator

测量时间点：

基线和6周干预后

测量方法：

采用6 × 20+20 m折返重复冲刺测试，记录各次冲刺完成时间，并计算平均冲刺时间，单位为秒。

Measure time point of outcome：

Testing was conducted at baseline and upon completion of the 6-week intervention.

Measure method：

Repeated sprint ability was assessed using a 6 × 20+20 m repeated shuttle sprint test. The completion time for each sprint was recorded, and the mean sprint time was subsequently calculated, with all values expressed in seconds.

指标中文名：

重复冲刺疲劳指数

指标类型：

次要指标

Outcome：

Repeated-sprint fatigue index

Type：

Secondary indicator

测量时间点：

基线和6周干预后

测量方法：

根据重复冲刺测试中最快时间、平均时间或总时间计算疲劳指数，用于评价重复冲刺过程中表现下降程度。

Measure time point of outcome：

Testing was conducted at baseline and upon completion of the 6-week intervention.

Measure method：

The fatigue index (FI) was derived from the fastest sprint time, mean sprint time, or total sprint time obtained from the repeated sprint test. This index served as an indicator of the extent to which performance declined across successive sprints.

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

 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 岁 years
最大 Max age 24 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

采用1:1区组随机化，区组大小为4。随机分配序列由不参与招募、干预实施、结局评估和数据分析的独立研究者使用计算机随机数生成器生成。

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

Participants will be randomly allocated to the BET group or control group in a 1:1 ratio using block randomization with a block size of 4. The random allocation sequence will be generated by an independent researcher using a computerized random number generator.

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：

由于训练干预性质，受试者和训练实施人员无法实施盲法；但结局评估者和数据分析人员将保持盲态，不知晓受试者分组。

Blinding：

Due to the nature of the training intervention, participants and training personnel cannot be blinded. However, outcome assessors and data analysts will remain blinded to group allocation.

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）：

无

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

None

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：

本研究采用统一的病例报告表和电子数据库进行数据采集与管理。所有受试者分配唯一研究编号，个人身份信息与研究数据分开保存。训练出勤、认知任务表现、足球专项测试、重复冲刺测试、心理疲劳VAS、RPE及不良事件均由经过培训的研究人员记录。数据录入后进行双人核对，并定期进行范围检查和逻辑检查。电子数据存储于加密电脑和密码保护文件中，仅研究团队授权成员可访问。统计分析前将对数据进行匿名化处理。

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

Data will be collected using standardized case report forms and an electronic database. Each participant will be assigned a unique study identification code, and personal identifiers will be stored separately from research data. Training attendance, cognitive-task performance, soccer-specific tests, repeated-sprint tests, mental fatigue VAS, RPE, and adverse events will be recorded by trained researchers. Data will be double-checked after entry, and regular range and logic checks will be performed. Electronic data will be stored on password-protected computers and encrypted files, accessible only to authorized research team members. Data will be anonymized before statistical analysis.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-06-22 20:21:01