ChiCTR2500114475 版本V1.1 版本创建时间2025/12/14 22:45:29 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：

 ChiCTR2500114475 

最近更新日期：

Date of Last Refreshed on：

 2025-12-12 14:13:35 

注册时间：

Date of Registration：

 2025-12-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

急性体感游戏对久坐大学生抑制控制的剂量效应

Public title：

The Dose-Effect of Acute Exergaming on Inhibitory Control in Sedentary University Students

注册题目简写：

English Acronym：

研究课题的正式科学名称：

急性体感游戏对久坐大学生抑制控制的剂量效应研究：来自fNIRS的证据

Scientific title：

Dose-Response Effects of Acute Exergaming on Inhibitory Control in Sedentary University Students: An 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：

王意 

研究负责人：

赵洪朋 

Applicant：

Wang Yi 

Study leader：

Zhao Hongpeng 

申请注册联系人电话：

Applicant telephone：

 +86 166 8812 3324

研究负责人电话：

Study leader's
telephone：

+86 138 9796 6507

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：

 16688123324@163.com

研究负责人电子邮件：

Study leader's E-mail：

 Clark-72@163.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：

中国辽宁省沈阳市苏家屯区金钱松东路36号

研究负责人通讯地址：

中国辽宁省沈阳市苏家屯区金钱松东路36号

Applicant address：

36 Jinqiansong East Road, Sujiatun District, Shenyang City, Liaoning Province, China

Study leader's address：

36 Jinqiansong East Road, Sujiatun District, Shenyang City, Liaoning Province, China

申请注册联系人邮政编码：

Applicant postcode：

 110102

研究负责人邮政编码：

Study leader's postcode：

 110102

申请人所在单位：

中国辽宁省沈阳市沈阳体育学院运动健康学院

Applicant's institution：

School of Exercise and Health, Shenyang Sport University, Shenyang, Liaoning Province,China

研究负责人所在单位：

中国辽宁省沈阳市沈阳体育学院运动健康学院

Affiliation of the Leader：

School of Exercise and Health, Shenyang Sport University, Shenyang, Liaoning Province

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 伦理字(2025)53号

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：

沈阳体育学院伦理委员会

Name of the ethic committee：

Shenyang Sport University Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-10-10 00:00:00

伦理委员会联系人：

张广志

Contact Name of the ethic committee：

Zhang Guangzhi

伦理委员会联系地址：

中国辽宁省沈阳市苏家屯区金钱松东路36号沈阳体育学院

Contact Address of the ethic committee：

36 Jinqiansong East Road, Sujiatun District, Shenyang City, Liaoning Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 180 4136 6953

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：

运动健康学院

Primary sponsor：

School of Exercise and Health

研究实施负责（组长）单位地址：

中国辽宁省沈阳市苏家屯区金钱松东路36号

Primary sponsor's address：

36 Jinqiansong East Road, Sujiatun District, Shenyang City, Liaoning Province, 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)：

辽宁

市(区县)：

沈阳

Country：

China

Province：

Liaoning

City：

Shenyang

单位(医院)：

沈阳体育学院

具体地址：

中国辽宁省沈阳市苏家屯区金钱松东路36号

Institution
hospital：

Shenyang Sport University

Address：

36 Jinqiansong East Road, Sujiatun District, Shenyang City, Liaoning Province, China

经费或物资来源：

沈阳体育学院研究生创新实践资助项目

Source(s) of funding：

The Graduate Innovation and Practice Fund of Shenyang Sport University.

研究疾病：

抑制控制  

Target disease：

Inhibitory control

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：

随机交叉对照 

Study design：

Cross-over 

研究目的：

探讨急性体感游戏对久坐大学生抑制控制的剂量效应及神经机制  

Objectives of Study：

This study aimed to investigate the dose-response relationship of an acute bout of exergaming on inhibitory control and its underlying neural mechanisms in sedentary university students with high recreational screen time.

药物成份或治疗方案详述：

1. 中强度-高认知条件：选用任天堂体感游戏中的“大冒险”，参与者位于屏幕前约2米处，需交替执行跑步、跳跃与下蹲等动作，以击打怪物、躲避障碍物并收集金币等奖励，最终抵达终点。中强度体现在持续性的加速跑动与身体位移；高认知参与体现在障碍物与金币的随机出现，要求参与者在运动中持续进行观察、辨别与决策。 2. 中强度-低认知条件：选用任天堂体感游戏中的“马拉松”，参与者位于屏幕前约2米处，任务为以最大努力持续跑动。游戏中无障碍物或路径选择，仅体现中运动强度属性。 3. 低强度-高认知条件：选用任天堂体感游戏中的“羽毛球”，参与者需根据游戏提示，判断来球的位置与类型并进行回击。游戏过程无需大幅移动，但对手回球具有随机性，要求参与者持续判断击球时机、方向与类型，并调动空间距离判断能力，因此体现了高认知参与属性。 4. 低强度-低认知条件：选用任天堂体感游戏中的“瑜伽”，被试全程只需模仿游戏中的简单动作，既无大幅度肢体活动，也无需过多思考。 

Description for medicine or protocol of treatment in detail：

1. Moderate Intensity-High Cognitive Engagement: Adventure Game (Nintendo). Participants stood about 2 meters from the screen and alternated between running, jumping, and squatting to hit monsters, avoid obstacles, and collect rewards such as coins, ultimately reaching the finish line. The moderate intensity was reflected in sustained running and body displacement, while high cognitive engagement was reflected in the random appearance of obstacles and coins, requiring participants to continuously observe, distinguish, and make decisions during exercise. 2. Moderate Intensity-Low Cognitive Engagement: Marathon Game (Nintendo). Participants stood about 2 meters from the screen, and the task was to run continuously at maximum effort, with no obstacles or path choices, reflecting only moderate exercise intensity. 3. Low Intensity-High Cognitive Engagement: Badminton Game (Nintendo). Participants had to judge the position and type of incoming balls based on game prompts and return them. The game did not require significant movement, but the random returns from the opponent required participants to continuously judge the timing, direction, and type of their shots, engaging their spatial judgment abilities and reflecting high cognitive engagement. 4. Low Intensity-Low Cognitive Engagement: Yoga Game (Nintendo). Participants only needed to imitate simple movements from the game, without extensive body movement or significant cognitive processing required. 

纳入标准：

1.健康状况：自我报告身体健康，无脑部创伤史及神经系统疾病（如脑震荡、癫痫、中风等）； 2.视觉功能：辨色能力正常，能够准确分辨红、绿、蓝等颜色，能顺利完成Stroop任务； 3.情绪状态：自我报告无临床诊断的焦虑症、抑郁症或其他严重影响认知功能的情緒障碍； 4.久坐行为：依据《成年人久坐行为问卷》中文版评估，其过去一周平均每日娱乐视频类久坐时间（包括无目的浏览网页、被动观看视频等）大于3小时； 5.知情同意：能够理解研究流程，自愿参与并签署书面知情同意书。

Inclusion criteria

1.Health Status: Self-reported good health, without a history of head trauma or neurological disorders (e.g., concussion, epilepsy, stroke); 2.Visual Function: Normal color discrimination ability, capable of accurately distinguishing red, green, and blue colors, and able to successfully complete the Stroop task; 3.Emotional State: Self-reported absence of clinically diagnosed anxiety, depression, or other mood disorders that severely affect cognitive function; 4.Sedentary Behavior: Assessed using the Chinese version of the Adults Sedentary Behavior Questionnaire, average daily recreational screen-based sedentary time (including non-purposeful web browsing, passive video watching) in the past week exceeded 3 hours; 5.Informed Consent: Ability to understand the study procedures, voluntary participation, and provision of written informed consent.

排除标准：

排除标准 1.神经系统与精神疾病史：有明确诊断的神经系统疾病、精神类疾病或严重的头部外伤史； 2.色觉障碍：存在色盲、色弱等辨色能力异常，经标准色觉测试图筛查确认； 3.情绪障碍：有临床诊断的焦虑、抑郁等情绪障碍，或正在服用相关精神类药物； 4.体力活动水平：为高水平运动员或规律从事高强度体力活动（依据《国际体力活动问卷》评估，体力活动水平处于高度活跃范畴），无法满足“久坐”核心特征； 5.运动禁忌症：存在骨骼、肌肉、心血管或其他系统疾病，无法安全完成中等强度体感游戏干预。

Exclusion criteria：

1.History of Neurological or Psychiatric Disorders: A clear diagnosis of neurological diseases, psychiatric disorders, or history of severe head trauma; 2.Color Vision Deficiency: Presence of color blindness or color weakness, confirmed by standard color vision test charts; 3.Mood Disorders: Clinical diagnosis of anxiety, depression, or other mood disorders, or current use of related psychotropic medications; 4.Physical Activity Level: Being a high-level athlete or regularly engaging in high-intensity physical activity (assessed by the International Physical Activity Questionnaire as falling into the highly active category), thus not meeting the core characteristic of being "sedentary"; 5.Contraindications to Exercise: Presence of musculoskeletal, cardiovascular, or other systemic diseases that prevent safe completion of the moderate-intensity exergaming intervention.

研究实施时间：

Study execute time：

从 From 2025-12-13 00:00:00至 To 2026-03-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-13 00:00:00 至 To 2025-12-30 00:00:00

干预措施：

Interventions：

组别：

序列 1（顺序组 1）： A（中强度-高认知）→ B（中强度-低认知）→ D（低强度-低认知）→ C（低强度-高认知）

样本量：

 7

Group：

Sequence 1 (Order Group 1): A (moderate-intensity, high cognitive engagement) → B (moderate-intensity, low cognitive engagement) → D (low-intensity, low cognitive engagement) → C (low-intensity, high cognitive engagement).

Sample size：

干预措施：

序列 1:A:中强度-高认知条件（任天堂体感游戏中的“马拉松”）-B:中强度-低认知条件（任天堂体感游戏中的“羽毛球”）-C:低强度-高认知条件（任天堂体感游戏中的“马拉松”）-D:低强度-低认知条件（任天堂体感游戏中的“瑜伽”）

干预措施代码：

Intervention：

Sequence 1: A (moderate-intensity, high cognitive engagement, using the "Marathon" exergame on Nintendo) → B (moderate-intensity, low cognitive engagement, using the "Badminton" exergame on Nintendo) → D (low-intensity, low cognitive engagement, using the "Yoga" exergame on Nintendo) → C (low-intensity, high cognitive engagement, using the "Marathon" exergame on Nintendo).

Intervention code：

组别：

序列 2（顺序组 2）： B（中强度-低认知）→ C（低强度-高认知）→ A（中强度-高认知）→ D（低强度-低认知）

样本量：

 7

Group：

Sequence 2 (Order Group 2): B (moderate-intensity, low cognitive engagement) → C (low-intensity, high cognitive engagement) → A (moderate-intensity, high cognitive engagement) → D (low-intensity, low cognitive engagement).

Sample size：

干预措施：

序列2：B:中强度-低认知条件（任天堂体感游戏中的“羽毛球”）→ C:低强度-高认知条件（任天堂体感游戏中的“马拉松”）→ A:中强度-高认知条件（任天堂体感游戏中的“马拉松”）→ D:低强度-低认知条件（任天堂体感游戏中的“瑜伽”）

干预措施代码：

Intervention：

Sequence 2: B (moderate-intensity, low cognitive engagement, using the "Badminton" exergame on Nintendo) → C (low-intensity, high cognitive engagement, using the "Marathon" exergame on Nintendo) → A (moderate-intensity, high cognitive engagement, using the "Marathon" exergame on Nintendo) → D (low-intensity, low cognitive engagement, using the "Yoga" exergame on Nintendo).

Intervention code：

组别：

序列 3（顺序组 3）： C（低强度-高认知）→ D（低强度-低认知）→ B（中强度-低认知）→ A（中强度-高认知）

样本量：

 7

Group：

Sequence 3 (Order Group 3): C (low-intensity, high cognitive engagement) → D (low-intensity, low cognitive engagement) → B (moderate-intensity, low cognitive engagement) → A (moderate-intensity, high cognitive engagement).

Sample size：

干预措施：

序列 3：C:低强度-高认知条件（任天堂体感游戏中的“马拉松”）→ D:低强度-低认知条件（任天堂体感游戏中的“瑜伽”）→ B:中强度-低认知条件（任天堂体感游戏中的“羽毛球”）→ A:中强度-高认知条件（任天堂体感游戏中的“马拉松”）

干预措施代码：

Intervention：

Sequence 3: C (low-intensity, high cognitive engagement, using the "Marathon" exergame on Nintendo) → D (low-intensity, low cognitive engagement, using the "Yoga" exergame on Nintendo) → B (moderate-intensity, low cognitive engagement, using the "Badminton" exergame on Nintendo) → A (moderate-intensity, high cognitive engagement, using the "Marathon" exergame on Nintendo).

Intervention code：

组别：

序列 4（顺序组 4）： D（低强度-低认知）→ A（中强度-高认知）→ C（低强度-高认知）→ B（中强度-低认知）

样本量：

 7

Group：

Sequence 4 (Order Group 4): D (low-intensity, low cognitive engagement) → A (moderate-intensity, high cognitive engagement) → C (low-intensity, high cognitive engagement) → B (moderate-intensity, low cognitive engagement).

Sample size：

干预措施：

序列 4：D:低强度-低认知条件（任天堂体感游戏中的“瑜伽”）→ A:中强度-高认知条件（任天堂体感游戏中的“马拉松”）→ C:低强度-高认知条件（任天堂体感游戏中的“马拉松”）→ B:中强度-低认知条件（任天堂体感游戏中的“羽毛球”）

干预措施代码：

Intervention：

Sequence 4: D (low-intensity, low cognitive engagement, using the "Yoga" exergame on Nintendo) → A (moderate-intensity, high cognitive engagement, using the "Marathon" exergame on Nintendo) → C (low-intensity, high cognitive engagement, using the "Marathon" exergame on Nintendo) → B (moderate-intensity, low cognitive engagement, using the "Badminton" exergame on Nintendo).

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 辽宁 

市(区县)：

 沈阳 

Country：

China

Province：

Liaoning

City：

Shenyang

单位(医院)：

 沈阳体育学院 

单位级别：

 大学 

Institution
hospital：

Shenyang Sport University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

抑制控制（反应抑制和冲突控制的反应时和正确率及前额叶脑激活的HbO-β值）

指标类型：

主要指标

Outcome：

inhibitory control (including reaction time and accuracy for both response inhibition and conflict control, as well as β-values of oxygenated hemoglobin [HbO] reflecting prefrontal cortex activation).

Type：

Primary indicator

测量时间点：

在每一次(共四次)体感游戏干预结束后即刻进行测量

测量方法：

Measure time point of outcome：

Measurements were taken immediately after each of the four exergame intervention sessions.

Measure method：

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 岁 years
最大 Max age 岁 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）：

由于随机交叉实验设计，四种干预条件的呈现顺序通过平衡拉丁方设计进行随机平衡。具体而言，首先将四种条件（基于运动强度与认知参与的2×2因子组合）编码为：A（低强度-低认知参与）、B（低强度-高认知参与）、C（中强度-低认知参与）、D（中强度-高认知参与）。随后，构建一个4×4 平衡拉丁方阵*（研究计划书中提供拉丁方阵），从而生成四种不同的干预顺序序列：序列1 (A, B, D, C)；序列2 (B, C, A, D)；序列3 (C, D, B, A)；序列4 (D, A, C, B)。该设计确保：（1）每种条件在四个顺序位置上均出现且仅出现一次；（2）任一条件在其他任一条件之前和之后出现的次数严格相等，从而在顺序上实现了完全平衡。 所有参与者被随机分配至上述四种顺序序列中的一种（每种序列分配7名参与者）。每名参与者每周接受一种条件的干预，连续干预周次之间设有1周的洗脱期，以最大限度地减少前次干预对后续测量的影响

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

Due to the cross-over experimental design, the presentation order of the four intervention conditions was randomized and balanced using a balanced Latin square design. Specifically, the four conditions (based on the 2×2 combination of exercise intensity and cognitive engagement) were coded as: A (low intensity – low cognitive engagement), B (low intensity – high cognitive engagement), C (moderate intensity – low cognitive engagement), and D (moderate intensity – high cognitive engagement). A 4×4 balanced Latin square matrix* (provided in the study protocol) was then constructed to generate four distinct intervention sequence orders: Sequence 1 (A, B, D, C); Sequence 2 (B, C, A, D); Sequence 3 (C, D, B, A); Sequence 4 (D, A, C, B). This design ensures that: (1) each condition appears once and only once in each of the four sequence positions; (2) each condition appears equally before and after every other condition, thus achieving a completely balanced order. All participants were randomly assigned to one of the four sequence orders (7 participants per sequence). Each participant received one intervention condition per week, with a one-week washout period between consecutive intervention weeks to minimize the impact of prior interventions on subsequent measurements.

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：

双盲实验设计:受试者和干预研究人员施盲。受试者并未知晓实验目的,并一直隐蔽至实验结束,干预研究人员为研究助理并未知晓研究目的,仅知晓干预方案实施。

Blinding：

A double-blind design was implemented wherein both participants and intervention administrators were blinded to the experimental conditions. Participants remained unaware of the study's specific hypotheses throughout the investigation, and this concealment was maintained until study completion. The intervention administrators, serving as research assistants, were unaware of the research objectives and were solely responsible for implementing the prescribed intervention protocols.

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

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）：

研究结束后6月内数据共享于投稿网站，期刊网址:https://jmirpublications.com/

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

Data will be shared on the submission website of the journal (https://jmirpublications.com) within six months after study completion.

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：

为确保本研究所有数据的质量、安全与可追溯性,特制定本数据管理制度,涵盖数据从产生到归档的全过程。 （1）数据采集 行为学数据:通过E-Prime 3.0软件程序自动采集并记录,生成原始数据文件(.edat等格式)。 脑功能数据:通过日本岛津LABNIRS/16型近红外脑成像仪采集,设备自动生成原始光学数据文件(.txt格式)。 问卷及一般信息数据:通过纸质版《久坐行为问卷》、《国际体力活动问卷》及基本信息调查表进行收集。 运动强度监控数据:通过Polar H9心率带监测,数据存储于Polar官方应用或导出为电子文件。 所有数据文件在创建时均以参试者唯一编号ID进行命名,绝不使用任何可识别个人身份的信息(如姓名、学号)。 （2） 源数据及其文件的管理 本研究的源数据包括所有原始、未经更改的第一手记录,具体包括:E-Prime生成的原始行为数据文件、fNIRS仪器采集的原始光学数据文件、填写完毕的纸质问卷、Polar心率原始数据记录。 电子源数据管理:所有电子源数据在采集后,由数据录入员及时备份至本研究专用的、受密码保护的加密硬盘中。存储路径按“参试者ID→数据类型→采集日期”的层级进行组织,确保结构清晰。 纸质源数据管理:所有纸质问卷和记录表在收集后,立即由研究人员标注参试者ID和收集日期,并存放于带锁的文件柜中,由专人保管。 （3）数据采集和录入(记录)人员 数据采集员:由经过统一培训的研究团队成员担任,负责操作E-Prime程序、fNIRS设备、Polar心率带及发放问卷,确保数据在源头采集的规范性。 （4）数据核对制度 首次核对(完整性核对):数据录入员在完成数据转录或预处理后,需立即核对数据数量与参试者ID是否对应完整,检查是否存在明显缺失或异常值。 二次核对(准确性核对):由另一名未参与首次录入的研究人员,随机抽取不少于总样本量20%的数据,将电子数据与纸质源数据或原始数据文件进行比对,确保转录和处理的准确性。核对结果需记录备案。 最终核对(锁定数据库):在所有数据收集完毕并完成初步分析后,研究负责人将对整个数据库进行最终审核。审核无误后,将数据库锁定。锁定的数据库即为最终分析数据集,任何后续修改均需由研究负责人提出申请并记录修改原因。

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

To ensure the quality, security, and traceability of all data in this study, a comprehensive data management protocol was established, governing data from acquisition to archival. (1) Data Acquisition Behavioral data were automatically collected and recorded by the E-Prime 3.0 software, generating raw data files (.edat format). Functional brain data were acquired using a Shimadzu LABNIRS/16 fNIRS system, which automatically generated raw optical data files (.txt format). Questionnaire and general information data were collected via paper-based versions of the Sedentary Behavior Questionnaire, International Physical Activity Questionnaire, and a basic information form. Exercise intensity monitoring data were recorded using a Polar H9 heart rate sensor, with data stored either in the official Polar application or exported as electronic files. All data files were named at creation using the participant's unique identification number, with no use of personally identifiable information. (2) Management of Source Data and Files Source data comprised all original, unaltered primary records. Electronic source data were promptly backed up to a dedicated, password-protected encrypted hard drive, organized hierarchically by participant ID, data type, and collection date. Paper-based source data were immediately labeled with participant ID and collection date before being stored in a locked filing cabinet under the custody of designated personnel. (3) Data Collection and Recording Personnel Trained research staff were responsible for operating all data collection equipment and administering questionnaires to ensure standardized procedures. (4) Data Verification Protocol Initial verification checked data completeness and correspondence with participant IDs. Secondary verification involved an independent researcher randomly cross-checking at least 20% of the dataset against original records. A final audit was conducted by the principal investigator before the database was formally locked, with any subsequent modifications requiring documented justification.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

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  2025-12-12 14:13:31