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注册号: Registration number: |
ChiCTR2500111739 |
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最近更新日期: Date of Last Refreshed on: |
2025-11-05 11:09:20 |
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注册时间: Date of Registration: |
2025-11-05 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: |
绿蓝环境暴露联合太极拳运动对老年男性情绪健康影响的实验研究 |
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Public title: |
An Experimental Study on the Effects of Green and Blue Environment Exposure Combined with Tai Chi Exercise on Emotional Health of Elderly Males |
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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: |
绿蓝环境暴露联合太极拳运动对老年男性情绪健康影响的实验研究 |
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Scientific title: |
An Experimental Study on the Effects of Green and Blue Environment Exposure Combined with Tai Chi Exercise on Emotional Health of Elderly Males |
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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: |
孙红梅 |
研究负责人: |
孙红梅 |
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Applicant: |
Hongmei Sun |
Study leader: |
Hongmei Sun |
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申请注册联系人电话: Applicant telephone: |
+86 182 6641 5076 |
研究负责人电话:
Study leader's |
+86 182 6641 5076 |
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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: |
511633810@qq.com |
研究负责人电子邮件: Study leader's E-mail: |
511633810@qq.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: |
山东济南市世纪大道10600号 |
研究负责人通讯地址: |
山东济南市世纪大道10600号 |
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Applicant address: |
10600 Shiji Avenue, Jinan, Shandong, China |
Study leader's address: |
10600 Shiji Avenue, Jinan, Shandong, China |
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申请注册联系人邮政编码: Applicant postcode: |
250102 |
研究负责人邮政编码: Study leader's postcode: |
250102 |
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申请人所在单位: |
山东体育学院 |
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Applicant's institution: |
Shandong Sport University |
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研究负责人所在单位: |
山东体育学院 |
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Affiliation of the Leader: |
Shandong Sport University |
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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: |
2025066 |
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: |
山东体育学院运动科学伦理委员会 |
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Name of the ethic committee: |
Sports Science Ethics Committee of Shandong Sport University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-10-29 00:00:00 | ||
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伦理委员会联系人: |
陈阳雷 |
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Contact Name of the ethic committee: |
Yanglei Chen |
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伦理委员会联系地址: |
山东济南市世纪大道10600号 |
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Contact Address of the ethic committee: |
10600 Shiji Avenue, Jinan, Shandong, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 151 6511 0246 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
stkjcyx@163.com |
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研究实施负责(组长)单位: |
山东体育学院 |
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Primary sponsor: |
Shandong Sport University |
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研究实施负责(组长)单位地址: |
山东济南市世纪大道10600号 |
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Primary sponsor's address: |
10600 Shiji Avenue, Jinan, Shandong, 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: |
山东省社科规划项目(项目批准号:24CTYJ13) |
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Source(s) of funding: |
the Social Science Planning Fund of Shandong Province (Grant No. 24CTYJ13) |
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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: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
I期临床试验 | ||||||||||||||||||||||
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Study phase: |
1 |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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研究目的: |
探究绿蓝环境暴露联合太极拳运动对老年男性短时情绪的影响,对比分析短时不同类型环境暴露联合太极拳运动的情绪改善效果及联合干预后不同类型环境继续暴露对短时情绪改善效果维持的差异。 |
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Objectives of Study: |
To investigate the effects of green and blue environment exposure combined with Tai Chi exercise on short-term emotions in elderly males, and to compare the emotional improvement efficacy of short-term combined interventions with different environmental types, as well as the maintenance differences of emotional benefits under continuous post-intervention exposure to distinct environments. |
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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.体力活动水平高者、实验地点在工作或住地附近者; 2.实验前受伤,饮酒、浓茶、咖啡等饮料,过度食用辛辣等刺激性食品,吃药,情绪波动较大者等。 |
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Exclusion criteria: |
1.Individuals with high physical activity levels or those for whom the experimental site was near their workplace or residence. 2.Individuals who were injured before the experiment, consumed alcohol, strong tea, coffee or other stimulating foods (e.g., spicy food), took medication or showed significant emotional fluctuations. |
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研究实施时间: Study execute time: |
从 From 2025-10-29 00:00:00至 To 2026-06-15 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2025-10-31 00:00:00 至 To 2026-04-30 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: |
正在进行 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): |
项目负责人采用随机数字法分组 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
The Principal Investigator adopted the random number method for grouping |
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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: |
开放标签 |
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Blinding: |
Open label |
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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 |
否No |
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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): |
511633810@qq.com,在实验结束六个月时间内上传 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
511633810@qq.com, to be uploaded within six months of the experiment's conclusion. |
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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: |
电子采集和管理系统 |
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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 |