审核状态: Project audit state: |
通过审核 Successful |
注册号: Registration number: |
ChiCTR2000035138 |
最近更新时间: Date of Last Refreshed on: |
2020/8/2 0:23:05 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
填写语言: |
中文和英文 |
Language: |
Chinese And English |
注册题目: |
运动-营养干预促进健康的研究 |
Public title: |
Study on health promotion by exercise nutrition intervention |
注册题目简写: |
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Public title acronym: |
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研究课题的正式科学名称: |
多中心运动-营养干预促进健康的中国方案 |
Scientific title: |
Exercise-nutrition intervention for health promotion in China: a multicenter study |
研究课题的正式科学名称简写: |
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Scientific title acronym: |
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研究课题代号(代码): Study subject ID: |
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在其它机构的注册号: Secondary ID: |
申请注册联系人: |
廖八根 |
研究负责人: |
胡敏 |
Applicant: |
Liao Bagen |
Study leader: |
Hu Ming |
申请注册联系人电话: Applicant telephone: |
+86 13527602478 |
研究负责人电话: Study leader's telephone: |
+86 20-38027669 |
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: |
bagen2015@163.com |
研究负责人电子邮件: Study leader's E-mail: |
whoomin@aliyun.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): |
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申请注册联系人通讯地址: |
广州省广州市天河区广州大道中1268号 |
研究负责人通讯地址: |
广州省广州市天河区广州大道中1268号 |
Applicant address: |
1268 Middle Guangzhou Avenue, Tianhe District, Guangzhou, Guangdong, China |
Study leader's address: |
1268 Middle Guangzhou Avenue, Tianhe District, Guangzhou, Guangdong, 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: |
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申请人所在单位: |
广州体育学院 |
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Applicant's institution: |
Guangzhou Sport University |
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: |
2020LCLL-003 |
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: |
广州体育学院伦理审查委员会 |
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Name of the ethic committee: |
Human Experimental Ethics Inspection of Guangzhou Sport University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-05-11 | ||
国家FDA批准文号: Approved No. of SFDA: |
国家FDA批准附件: Approved file of SFDA: |
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国家FDA批准日期: Date of approved by SFDA: |
研究实施负责(组长)单位: |
广州体育学院 |
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Primary sponsor: |
Guangzhou Sport University |
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研究实施负责(组长)单位地址: |
广州省广州市天河区广州大道中1268号 |
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Primary sponsor's address: |
1268 Guangzhou Avenue, Guangzhou, Guangdong, 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: |
国家重点研发计划 2020YFC2002904 |
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Source(s) of funding: |
national key research and development plan |
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研究疾病: |
健康人、高血压、糖尿病、肥胖、营养不良 |
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Target disease: |
Hypertension, Diabetes, Obese, Undernutrition |
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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: |
其它 | ||||||||||||||||||||||
Study phase: |
N/A |
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研究目的: |
构建有效的社区营养-运动干预模式。 (1)运动结合NMN补充对心肺耐力影响。 (2)运动-营养联合干预模式对不同慢病(高血压、糖尿病、肥胖、营养不良)中老年的健康影响。 |
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Objectives of Study: |
To construct an effective community nutrition exercise intervention model. 1. Exercise combined with NMN supplementation has an effect on cardiopulmonary endurance. 2. Exercise nutrition combined intervention mode has an impact on the health of middle-aged and elderly people with different chronic diseases (hypertension, diabetes, obesity, malnutrition). |
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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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纳入标准: |
1)40岁以上本区常住居民,有较好的依从性并签署知情同意书。 2)自愿参与实验。 3)运动和营养风险评估筛选为中低风险的。 |
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Inclusion criteria |
1. Residents over 40 years old in this district have good compliance and sign informed consent; 2. The subjects who participated in the experiment voluntarily; 3. The subjects with low and medium risk were screened by exercise and nutrition risk assessment. |
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排除标准: |
1)有严重听说障碍,不能理解该研究目的、内容者。 2)重要脏器(心、肺、肾等)功能严重障碍者; 4)其他原因不能安全参与评估者; 5)无法完成评估报告或遵守本研究要求者; |
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Exclusion criteria: |
1. There are serious listening and speaking barriers and can't understand the object of the research purpose and content; 2. Objects with serious dysfunction of vital organs (heart, lung, kidney, etc.); 3. The objects that cannot participate in the assessment safely due to other reasons; 4. Those who are unable to complete the evaluation report or comply with the requirements of this study. |
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研究实施时间: Study execute time: |
从From2020-08-01至To 2023-07-01 |
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 Pending |
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): |
随机方法采用随机数字表法。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
The random sequence will be gengered by using random number table. |
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UTN(全球唯一识别码): |
盲法: |
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Blinding: |
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试验完成后的统计结果: |
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Calculated Results ater
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研究负责(组长)单位: |
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Organizer institution (leader institution): |
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资料收集汇总单位: |
6M |
Data collection Institution: |
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资料管理单位: |
试验完成后6个月内公开;与研究负责人联系 |
Data management Institution: |
Open to the public within 6 months of completion of the trial; contact with research director of this trial |
资料分析单位: |
病例记录表 |
Data analysis Institution: |
CRF |