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注册号: Registration number: |
ChiCTR2500102610 |
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最近更新日期: Date of Last Refreshed on: |
2025-05-16 15:15:38 |
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注册时间: Date of Registration: |
2025-05-16 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
开放式和封闭式技能运动对执行功能发展的影响:针对优秀青少年运动员的前瞻性纵向队列研究方案 |
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Public title: |
Effects of Open- and Closed-Skill Sports on the Development of Executive Function: Protocol for a Prospective Longitudinal Cohort Study in Elite Youth Athletes |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
开放式与封闭式技能运动对青少年运动员认知发展的影响 |
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Scientific title: |
Effects of Open- and Closed-Skill Sports on Cognitive Development in Adolescent Athletes |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
孙沛杰 |
研究负责人: |
孙沛杰 |
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Applicant: |
Peijie Sun |
Study leader: |
Peijie Sun |
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申请注册联系人电话: Applicant telephone: |
+86 178 6417 5912 |
研究负责人电话:
Study leader's |
+86 178 6417 5912 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
17864175912@163.com |
研究负责人电子邮件: Study leader's E-mail: |
17864175912@163.com |
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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): |
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申请注册联系人通讯地址: |
四川省成都市武侯区体院路2号 |
研究负责人通讯地址: |
四川省成都市武侯区体院路2号 |
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Applicant address: |
No. 2 Tiyuan Road, Wuhou District, Chengdu City, Sichuan Province |
Study leader's address: |
No. 2 Tiyuan Road, Wuhou District, Chengdu City, Sichuan Province |
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申请注册联系人邮政编码: Applicant postcode: |
610041 |
研究负责人邮政编码: Study leader's postcode: |
610041 |
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申请人所在单位: |
成都体育学院(武侯校区) |
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Applicant's institution: |
Chengdu Sport University (Wuhou Campus) |
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研究负责人所在单位: |
成都体育学院(武侯校区) |
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Affiliation of the Leader: |
Chengdu Sport University (Wuhou Campus) |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
成体伦理 [2025] 95 号 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
成都体育学院伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of Chengdu Sport University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-04-30 00:00:00 | ||
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伦理委员会联系人: |
廖远朋 |
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Contact Name of the ethic committee: |
Yuanpeng Liao |
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伦理委员会联系地址: |
四川省成都市武侯区体院路2号成都体育学院 |
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Contact Address of the ethic committee: |
Chengdu Sport University, No. 2 Tiyuan Road, Wuhou District, Chengdu, Sichuan Province |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 182 0287 2188 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
成都体育学院 |
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Primary sponsor: |
Chengdu Sport University |
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研究实施负责(组长)单位地址: |
四川省成都市武侯区体院路2号成都体育学院 |
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Primary sponsor's address: |
Chengdu Sport University, No. 2 Tiyuan Road, Wuhou District, Chengdu, Sichuan Province |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
运动医学四川省暨国家体育总局重点实验室资助项目(No. 2025-A006) |
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Source(s) of funding: |
The Key Laboratory of Sports Medicine of Sichuan Province and the State Sports General Administration of China (No. 2025-A006). |
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研究疾病: |
无 |
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Target disease: |
None |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
队列研究 |
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Study design: |
Cohort study |
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研究目的: |
1.探讨开放式技能运动(水球)与封闭式技能运动(游泳)对青少年运动员执行功能(如抑制控制、注意分配和工作记忆)发展的不同影响。阐明不同运动类型与执行功能发展的关系。 2.通过连续5年的事件相关电位(ERP)测量,揭示青少年运动员在执行功能关键指标(如P3、N200等)上的发展轨迹,了解脑功能变化与运动经验之间的关系。 3.为运动选择策略、训练计划设计和青少年体育发展政策提供依据。 |
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Objectives of Study: |
1.To examine the differential effects of open-skill sports (water polo) and closed-skill sports (swimming) on the development of executive functions—such as inhibitory control, attentional allocation, and working memory—in elite youth athletes, and to clarify the relationship between sport type and cognitive development. 2.To track longitudinal changes in key executive function markers (e.g., P3, N200) over a five-year period using event-related potential (ERP) measures, thereby elucidating the developmental trajectory of brain function in relation to sustained sport-specific training. 3.To inform sport selection strategies, training program design, and youth athletic development policies by providing evidence-based insights into the cognitive impact of different sport types. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
1、有神经或精神疾病(如癫痫、注意力缺陷/多动障碍、自闭症谱系障碍)病史 2、有已知学习障碍或发育迟缓 3、有曾伴意识丧失的头部外伤史 4、目前或近期(过去4周)服用影响中枢神经系统或自主神经功能的药物(如β-受体阻滞剂、抗抑郁药)。 5、有吸烟或酗酒史 6、在筛选阶段不遵守训练或测试要求,或有其他项目正式训练经历者 |
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Exclusion criteria: |
1. Have a history of neurological or psychiatric diseases (such as epilepsy, attention-deficit/hyperactivity disorder, autism spectrum disorder). 2. Have a known learning disability or developmental delay 3. History of head trauma with loss of consciousness 4. Current or recent (past 4 weeks) taking drugs that affect the function of the central nervous system or autonomic nervous system (such as β-blockers, antidepressants). 5. Have a history of smoking or alcoholism 6. Those who do not comply with the training or testing requirements during the screening stage, or have formal training experience in other projects |
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研究实施时间: Study execute time: |
从 From 2025-11-01 00:00:00至 To 2032-06-30 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2025-11-01 00:00:00 至 To 2026-08-15 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
None |
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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 |
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盲法: |
由于本研究采用观察法设计,因此很难做到完全盲目。不过,在数据收集和分析的每个阶段,我们都将采用多种程序来最大限度地减少观察者可能出现的偏差。每位受试者在注册时都将被分配到一个通过随机程序生成的唯一匿名识别码。这些代码将隐藏参与者的运动类型、训练地点和竞技水平等信息。匿名代码将在数据收集、数据存储和后续分析过程中持续使用,以确保保密性。进行认知评估和神经电生理数据收集的研究人员将对运动员的运动类型保持盲目。为确保统一性,所有任务说明和实验程序都将标准化,测试环境也将受到严格控制,以消除可能无意中暴露参与者运动类型的间接指标,如服装或设备。所有脑电图和行为数据在处理前都将匿名化,数据文件由唯一的识别码标识。在初步分析完成之前,有关运动类型的信息将一直保密,以减少预处理、伪影剔除和统计建模过程中的偏差。数据分析人员只有在完成主要数据分析后才能获得运动类型变量。为进一步减少偏差,在进行最终统计分析之前,将由一名独立研究人员对数据标签和预处理程序进行验证。将定期进行审核,以确保遵守盲法程序。发现的任何违规行为都将记录在案,并按照既定标准予以纠正,以保持数据质量和研究的有效性。 |
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Blinding: |
Due to the observational design of this study, complete blinding will be difficult. Nonetheless, multiple procedures will be instituted to minimise potential observer bias at every phase of data collection and analysis. Upon enrolment, each participant will be assigned a unique anonymised identification code generated using a randomised procedure. These codes will conceal information about the participant's sport type, training location, and competitive level. The anonymised codes will be consistently used during data collection, data storage, and subsequent analyses to maintain confidentiality. Research staff conducting cognitive assessments and neurophysiological data collection will remain blinded to the athletes' sport type. To ensure uniformity, all task instructions and experimental procedures will be standardised, and the testing environment will be carefully controlled to eliminate indirect indicators, such as clothing or equipment, that might inadvertently reveal the participant's sport type. All EEG and behavioural data will be anonymised before processing, with data files identified by unique identification codes. Information regarding sport type will remain concealed until primary analyses are complete to reduce bias during pre-processing, artefact rejection, and statistical modelling. Data analysts will gain access to the sport type variable solely upon the completion of the primary data analyses. To further minimise any bias, an independent researcher will validate the data labelling and preprocessing procedures prior to the final statistical analyses. Regular audits will be carried out to ensure adherence to blinding procedures. Any violations identified will be recorded and rectified in accordance with established standards to maintain data quality and study validity. |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
是Yes |
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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): |
在项目结束后通过ResMan共享,网址为http://www.medresman.org.cn |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
The study data will be shared via the ResMan platform upon completion of the research. The website address is: http://www.medresman.org.cn. |
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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: |
EDC |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
EDC |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |