|
审核状态: Project audit state: |
通过审核 Successful |
|
注册号: Registration number: |
ChiCTR2500115052 |
|
最近更新日期: Date of Last Refreshed on: |
2025-12-22 10:43:06 |
|
注册时间: Date of Registration: |
2025-12-22 00:00:00 |
|
注册号状态: |
预注册 |
|
Registration Status: |
Prospective registration |
|
注册题目: |
抗阻训练运动零食对大学生下肢力量的影响 |
|
Public title: |
The Effects of Resistance Training "Exercise Snacks" on Lower Limb Strength in College Students |
|
注册题目简写: |
|
|
English Acronym: |
|
|
研究课题的正式科学名称: |
碎片化抗阻训练对大学生下肢肌肉力量的影响 |
|
Scientific title: |
Effects of Fragmented Resistance Training on Lower Limb Muscle Strength in College Students |
|
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: |
翟容萱 |
研究负责人: |
王乐军 |
|
Applicant: |
Rongxuan Zhai |
Study leader: |
Lejun Wang |
|
申请注册联系人电话: Applicant telephone: |
+86 185 0258 2702 |
研究负责人电话:
Study leader's |
+86 139 1622 1912 |
|
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: |
zhai_rx0812@163.com |
研究负责人电子邮件: Study leader's E-mail: |
wlj0523@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: |
中国上海市杨浦区四平路1239号 |
研究负责人通讯地址: |
中国上海市杨浦区四平路1239号 |
|
Applicant address: |
No. 1239, Siping Road, Yangpu District, Shanghai, China |
Study leader's address: |
No. 1239, Siping 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: |
同济大学 |
||
|
Applicant's institution: |
Tongji University |
||
|
研究负责人所在单位: |
同济大学 |
||
|
Affiliation of the Leader: |
Tongji University |
||
|
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: |
tjdxsr2025166 |
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: |
同济大学科技伦理委员会 |
||
|
Name of the ethic committee: |
Tongji University Science and Technology Ethics Committee |
||
|
伦理委员会批准日期: Date of approved by ethic committee: |
2025-12-12 00:00:00 | ||
|
伦理委员会联系人: |
陈虹 |
||
|
Contact Name of the ethic committee: |
Hong Chen |
||
|
伦理委员会联系地址: |
中国上海市杨浦区四平路1239号 |
||
|
Contact Address of the ethic committee: |
No. 1239, Siping Road, Yangpu District, Shanghai, China |
||
|
伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 21 6598 1573 |
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: |
同济大学 |
||||||||||||||||||||||
|
Primary sponsor: |
Tongji University |
||||||||||||||||||||||
|
研究实施负责(组长)单位地址: |
中国上海市杨浦区四平路1239号 |
||||||||||||||||||||||
|
Primary sponsor's address: |
No. 1239, Siping Road, Yangpu District, Shanghai, China |
||||||||||||||||||||||
|
试验主办单位(项目批准或申办者): Secondary sponsor: |
|
||||||||||||||||||||||
|
经费或物资来源: |
无 |
||||||||||||||||||||||
|
Source(s) of funding: |
None |
||||||||||||||||||||||
|
研究疾病: |
无 |
||||||||||||||||||||||
|
Target disease: |
None |
||||||||||||||||||||||
|
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: |
随机平行对照 |
||||||||||||||||||||||
|
Study design: |
Parallel |
||||||||||||||||||||||
|
研究目的: |
验证碎片化运动模式在提升力量水平上的可行性,还能揭示基于自我决定理论的心理机制对运动依从性的促进作用,为大学生群体提供更符合其学习节奏与心理特征的运动干预方案,为高校健康促进与体育课程改革提供科学依据。 |
||||||||||||||||||||||
|
Objectives of Study: |
This study aims to verify the feasibility of a fragmented exercise model in improving strength levels, while also elucidating the role of psychological mechanisms grounded in Self-Determination Theory in promoting exercise adherence. The findings are expected to inform the development of exercise intervention strategies that better align with college students’ learning schedules and psychological characteristics, and to provide scientific evidence for health promotion initiatives and physical education curriculum reform in higher education institutions. |
||||||||||||||||||||||
|
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) 通过身体活动准备问卷-加强版(PAR-Q+) 预筛查,无运动禁忌症;(2)有运动习惯;(3)在研究参与前的 3 个月内未参加竞技性运动或大强度抗阻训练 |
||||||||||||||||||||||
|
Inclusion criteria |
(1) Participants passed the pre-screening using the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+), with no contraindications to exercise ; (2) Participants had established exercise habits; (3) Participants had not engaged in competitive sports or high-intensity resistance training within the three months prior to study participation. |
||||||||||||||||||||||
|
排除标准: |
患有任何慢性疾病或其他可能因剧烈身体活动而加重的健康问题的个体 |
||||||||||||||||||||||
|
Exclusion criteria: |
Individuals with any chronic disease or other health conditions that may be exacerbated by vigorous physical activity. |
||||||||||||||||||||||
|
研究实施时间: Study execute time: |
从 From 2026-01-01 00:00:00至 To 2026-03-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2026-01-01 00:00:00 至 To 2026-01-05 00:00:00 |
|
干预措施: Interventions: |
|
|
研究实施地点: Countries of recruitment and research settings: |
|
||||||||||||||||||||||||||||
|
测量指标: Outcomes: |
|
|
采集人体标本:
Collecting sample(s)
|
|
|
征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
|
||||||
|
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): |
采用随机分组方法对受试者进行分组。随机序列由未参与招募、干预实施及结果评估的研究人员使用计算机随机数生成程序产生。随机分组比例为 1:1:1 |
||||||||
|
Randomization Procedure (please state who generates the random number sequence and by what method): |
A random allocation method was used to assign participants to study groups. The random sequence was generated using a computerized random number generator by a researcher who was not involved in participant recruitment, intervention implementation, or outcome assessment. Participants were allocated at 1:1:1. |
||||||||
|
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: |
由于运动干预的性质,本研究无法对受试者和训练指导人员实施盲法。然而,结果评估人员和数据统计分析人员均对分组情况保持盲态。所有数据在分析前进行匿名编码,直至统计分析完成后方解盲,以减少测量和分析偏倚。 |
|
Blinding: |
Due to the nature of the exercise intervention, blinding of participants and trainers was not feasible. However, outcome assessors and data analysts were blinded to group allocation. All data were anonymized and coded prior to analysis, and unblinding was performed only after completion of the statistical analyses to minimize assessment and analysis bias. |
|
试验完成后的统计结果(上传文件): |
|
|
Calculated Results after
|
|
|
是否共享原始数据: IPD sharing |
否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: |
本研究的数据采集和管理由两部分组成:病例记录表(Case Record Form,CRF)和电子数据采集与管理系统(Electronic Data Capture,EDC)。CRF 主要用于记录受试者的基本信息、基线特征、干预实施情况及各时间点的结局指标。所有 CRF 均由经过统一培训的研究人员填写,并在填写完成后进行双人核查,以确保数据的完整性和准确性。 在此基础上,研究采用基于互联网的电子数据采集与管理系统进行数据录入与管理。EDC 系统用于集中存储、管理和监控研究数据,并通过权限分级、操作日志记录和数据校验规则等方式保障数据安全性和可追溯性。所有数据均以匿名编码形式录入系统,仅研究负责人可访问完整数据。研究结束后,数据统一导出用于统计分析,并按伦理要求妥善保存。 |
|
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Data collection and management in this study consisted of two components: the Case Record Form (CRF) and an Electronic Data Capture (EDC) system. The CRF was used to document participants’ demographic information, baseline characteristics, intervention implementation, and outcome measures at each assessment time point. All CRFs were completed by trained research staff and were subjected to double-checking to ensure data completeness and accuracy. In addition, a web-based Electronic Data Capture system was used for data entry and management. The EDC system enabled centralized data storage, management, and monitoring, and ensured data security and traceability through role-based access control, audit trails, and built-in data validation rules. All data were entered in an anonymized and coded format, and only the principal investigator had access to the full dataset. Upon completion of the study, data were exported for statistical analysis and securely archived in accordance with ethical requirements. |
|
数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |