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注册号: Registration number: |
ChiCTR2600117967 |
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最近更新日期: Date of Last Refreshed on: |
2026-01-30 15:56:52 |
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注册时间: Date of Registration: |
2026-01-30 00:00:00 |
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注册号状态: |
补注册 |
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Registration Status: |
Retrospective registration |
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注册题目: |
大学生运动员功能性训练提升身体素质与运动表现实证研究 |
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Public title: |
Empirical Study on the Improvement of Physical Fitness and Athletic Performance in University Student-Athletes through Functional Training |
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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: |
大学生运动员身心健康的实证研究 |
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Scientific title: |
An Empirical Study on the Physical and Mental Health of University 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: |
解博渊 |
研究负责人: |
李思敏 |
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Applicant: |
Xie Boyuan |
Study leader: |
Lei Simin |
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申请注册联系人电话: Applicant telephone: |
+86 132 0160 9518 |
研究负责人电话:
Study leader's |
+853 8822 8720 |
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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: |
xieboyuan0406@163.com |
研究负责人电子邮件: Study leader's E-mail: |
alicelei@um.edu.mo |
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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): |
https://fed.um.edu.mo/zh-hant/alice-si-man-lei/ | |
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申请注册联系人通讯地址: |
中国陕西省西安市雁塔区锦业二路逸翠园一期十四号楼二单元102 |
研究负责人通讯地址: |
中国澳⻔氹仔澳⻔⼤学E33教育学院1015室 |
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Applicant address: |
Room 102, Unit 2, Building 14, Yicuiyuan (Phase I), Jinye 2nd Road, Yanta District, Xi’an, Shaanxi Province, China |
Study leader's address: |
Room 1015, E33 Education College, Macau University, Taipa, Macau, China |
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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: |
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申请人所在单位: |
澳门大学 |
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Applicant's institution: |
University of Macau |
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研究负责人所在单位: |
澳⻔⼤学 |
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Affiliation of the Leader: |
University of Macau |
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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: |
SSHRE21-APP047-FED |
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: |
澳门大学伦理委员会 |
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Name of the ethic committee: |
University of Macau Research Ethics Committee |
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伦理委员会批准日期: Date of approved by ethic committee: |
2021-10-07 00:00:00 | ||
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伦理委员会联系人: |
周憶粟 |
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Contact Name of the ethic committee: |
Yisu Zhou |
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伦理委员会联系地址: |
中国澳门氹仔大学马路 N6 号澳门大学行政楼5011室 |
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Contact Address of the ethic committee: |
Room 5011 Administration Building University of Macau, N6 Avenida da Universidade Taipa, Macau, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+853 8822 8722 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
zhouyisu@um.edu.mo |
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研究实施负责(组长)单位: |
澳门大学 |
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Primary sponsor: |
University of Macau |
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研究实施负责(组长)单位地址: |
中国澳门氹仔大学大马路澳门大学 |
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Primary sponsor's address: |
University of Macau, Avenida da Universidad de Taipa, Macau, China |
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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: |
自筹 |
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Source(s) of funding: |
Self-funded |
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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: |
None |
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Target disease code: |
None |
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研究类型: |
干预性研究 |
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Study type: |
Interventional 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: |
非随机对照试验 |
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Study design: |
Non randomized control |
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研究目的: |
探讨澳门和内地大专院校校队运动员功能性体能训练干预对功能性动作、身体素质及运动表现之影响。 |
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Objectives of Study: |
To explore the effects of functional fitness training intervention on functional movements, physical fitness and sports performance of athletes from Macau and mainland university teams. |
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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: |
排除身体受限、医学受限,在过去六周内曾接受任何形式的伤害,及曾经历任何肌肉骨骼手术的参与者。 |
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Exclusion criteria: |
Participants with physical or medical limitations, those who have suffered any form of injury in the past six weeks, or those who have undergone any musculoskeletal surgery will be excluded. |
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研究实施时间: Study execute time: |
从 From 2021-10-25 00:00:00至 To 2024-12-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2021-12-20 00:00:00 至 To 2021-12-26 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: |
结束 /Completed |
年龄范围: Participant age: |
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性别: |
男性 |
Gender: |
Male |
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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): |
本研究采用非随机分组方法,由研究团队负责设计分组方案。具体而言,根据学校校队的来源,将来自同一学校的队员分配到同一实验组或对照组,以确保组内的一致性和训练条件的可控性。随后,在校队内通过计算机生成的随机数(如Excel RAND函数或随机数表)进一步细分组内任务或干预顺序,从而实现一定程度的随机化。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
This study employs a semi-randomized grouping method designed by the research team. Specifically, participants from the same university team are allocated to the same experimental or control group to ensure consistency within groups and better control over training conditions. Subsequently, within each university team, further allocation or intervention sequence is determined using computer-generated random numbers (e.g., Excel's RAND function or a random number table) to incorporate an element of randomization. |
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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: |
不公开/Private |
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盲法: |
无 |
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Blinding: |
None |
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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): |
原始数据会于试验结束日期及安全数据结果统计后6 个月内提供。原始数据会加密脱敏后通过邮箱联系共享(具体邮箱为:lantzwu@um.edu.mo) |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Raw data will be provided within 6 months after the trial end date and the safety data results are collected. The original data will be encrypted and desensitized, and then shared via email (specific email: lantzwu@um.edu.mo). |
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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: |
所有数据将安全存储在受密码保护的文件或数据库中,访问权限严格限制为本文件中指定的研究团队成员。所有团队成员均需签署保密协议。为进一步保护隐私,参与者的身份标识符将在可能的情况下移除或加密,并根据研究要求对数据进行匿名化或去标识化处理。此外,除非法律要求或伦理审查委员会另有规定,未经参与者明确同意,任何信息均不会与第三方共享。 研究收集的数据将至少保存五年。在此期间,所有个人信息将被彻底删除,数据将转换为不包含任何个人标识符的匿名编码格式。加密文件将存储在主要研究员和研究助理的硬盘中,并通过密码保护以确保安全。 五年保存期结束后,匿名化数据将由主要研究员和研究助理继续安全存储,用于未来可能的研究需求。在获得必要许可的情况下,延长保存期旨在支持后续研究和验证当前研究结果的有效性。所有数据的访问将受到严格监控,仅限于获得主要研究员和研究助理明确授权的人员使用,且数据始终保持加密和密码保护状态。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
All data will be securely stored in password-protected files or databases, with access strictly limited to the designated research team members listed in this document. Each team member will be required to sign a confidentiality agreement. To further ensure privacy, participant identifiers will be removed or encrypted whenever possible, and data will be anonymized or de-identified as per research requirements. Additionally, participant information will not be shared with third parties without explicit consent, unless mandated by law or required by the ethics review board. The data collected in this study will be retained for a minimum of five years. During this period, all personal information will be permanently deleted, and the data will be converted into an anonymized, coded format devoid of any identifiable details. Encrypted files will be securely stored on hard drives owned by the principal investigator and research assistants, with password protection ensuring data security. After the five-year retention period, anonymized data will continue to be securely stored by the principal investigator and research assistants for potential future research purposes. If appropriate permissions are obtained, this extended retention period aims to facilitate follow-up studies and validate the findings of the current research. Access to all data will remain strictly controlled and limited to individuals explicitly authorized by the principal investigator and research assistants. Data will consistently remain encrypted and password-protected at all times. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
无/No |