Today is 2019-12-10

Adult Physical Fitness and Health Cohort Study (APFHCS)
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注册号:

Registration number:

ChiCTR1900024880 

最近更新日期:

Date of Last Refreshed on:

2019-08-01 

注册时间:

Date of Registration:

2019-08-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

成人体质与健康的队列研究 

Public title:

Adult Physical Fitness and Health Cohort Study (APFHCS) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

上海市老年人轻度认知障碍影响因素理论模型构建及评价 

Scientific title:

Theoretical model construction and evaluation of influencing factors of mild cognitive impairment in the elderly in Shanghai 

研究课题代号(代码):

Study subject ID:

2019HP76 

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:

刘悦文 

研究负责人:

于莹 

Applicant:

Liu Yuewen 

Study leader:

Yu Ying 

申请注册联系人电话:

Applicant telephone:

+86 15620467578 

研究负责人电话:

Study leader's telephone:

+86 13817664013 

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:

1981460083@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

yuy@sumhs.edu.cn 

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:

上海市浦东新区周祝公路279号 

研究负责人通讯地址:

上海市浦东新区周祝公路279号 

Applicant address:

279 Zhouzhu Road, Pudong New District, Shanghai, China 

Study leader's address:

279 Zhouzhu Road, Pudong New District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

201318 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

上海健康医学院 

Applicant's institution:

Shanghai University of Medicine & Health Sciences 

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:

2019-WJWXM-04-310108196508064467 

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:

上海健康医学院科研伦理委员会 

Name of the ethic committee:

Ethics Committee for Scientific Research of Shanghai University of Medicine & Health Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-10 

伦理委员会联系人:

孙吉 

Contact Name of the ethic committee:

Sun Ji 

伦理委员会联系地址:

上海市浦东新区周祝公路279号 

Contact Address of the ethic committee:

279 Zhouzhu Road, Pudong New District, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

上海健康医学院 

Primary sponsor:

Shanghai University of Medicine & Health Sciences 

研究实施负责(组长)单位地址:

上海市浦东新区周祝公路279号 

Primary sponsor's address:

279 Zhouzhu Road, Pudong New District, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海健康医学院

具体地址:

上海市浦东新区周祝公路279号

Institution
hospital:

Shanghai University of Medicine & Health Sciences

Address:

279 Zhouzhu Road, Pudong New District, Shanghai

经费或物资来源:

依托单位资助 

Source(s) of funding:

Funding by institution 

研究疾病:

生活方式与老年性疾病 

Target disease:

Lifestyle and senile Diseases 

研究疾病代码:

 

Target disease code:

 

研究类型:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

1.在合作医院开展相关的前瞻性研究,回顾性分析医院已有的近五年临床数据作为辅证,并结合现场采集的数据进行分析,明确上海地区老年人群MCI影响因素及其特点。 2.利用流行病学方法对影响因素数据进行统计分析,构建出影响变量的结构方程模型,并对路径系数检验评价,阐明上海市老年人MCI影响因素的内在关联和交互作用。 

Objectives of Study:

1. A prospective study was carried out in the cooperative hospital, and the clinical data in the past five years were analyzed retrospectively as auxiliary evidence, and combined with the data collected on the spot, the influential factors and characteristics of MCI in the elderly population in Shanghai were identified; 2. The data of influencing factors were statistically analyzed by epidemiological method, the structural equation model of influencing variables was constructed, and the path coefficient was tested and evaluated to clarify the intrinsic correlation and interaction of influencing factors of MCI in Shanghai elderly. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

(1)年龄≥65岁的老年人; (2)在社区居住至少一年; (3)知情同意,愿意配合相关检查。 

Inclusion criteria

(1) elderly people aged 65 years or older; (2) living in the community for at least one year; (3) informed consent, willing to cooperate with relevant examination. 

排除标准:

(1)严重认知障碍、痴呆、精神疾病或其他神经退行性病变; (2)生活不能自理,患有严重内外科疾病(如严重的外伤、脑卒中、癌症等),不能自主行走者; (3)存在听觉障碍、视觉障碍和交流困难者; (4)最近服用镇静药物者; (5)关节炎、帕金森、截肢等不能完成握力、TUGT、和4米测试者; (6)有心脏起搏器、心脏支架不能进行体成分测定者;  

Exclusion criteria:

(1) severe cognitive impairment, dementia, mental illness or other neurodegenerative diseases; (2) persons who are unable to take care of themselves and suffer from severe internal and surgical diseases (such as severe trauma, stroke, cancer, etc.) who are unable to walk on their own; (3) those with hearing impairment, visual impairment and communication difficulties; (4) those who have recently taken sedative drugs; (5) those who cannot complete grip strength, TUGT, and 4 meters of arthritis, Parkinson's, amputation, etc.; (6)those who had Cardiac pacemakers and cardiac stents cannot be measured for body composition. 

研究实施时间:

Study execute time:

From2019-09-01To 2024-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

2000

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Community Healthcare Service  

Level of the institution:

Community Health Service Center 

测量指标:

Outcomes:

指标中文名:

身体活动能力

指标类型:

主要指标 

Outcome:

physical performance

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

人体成分分析

指标类型:

主要指标 

Outcome:

body composition analysis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心率变异性

指标类型:

主要指标 

Outcome:

HRV

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身体活动量统计

指标类型:

主要指标 

Outcome:

IPAQ

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活习惯统计

指标类型:

主要指标 

Outcome:

life habits

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨密度

指标类型:

主要指标 

Outcome:

bone mineral density (BMD)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压

指标类型:

主要指标 

Outcome:

blood pressure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

动脉硬化

指标类型:

主要指标 

Outcome:

atherosclerosis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

营养

指标类型:

主要指标 

Outcome:

nutrition

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心情

指标类型:

主要指标 

Outcome:

mood

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

认知

指标类型:

主要指标 

Outcome:

cognition

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睡眠

指标类型:

主要指标 

Outcome:

sleep

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血生化

指标类型:

主要指标 

Outcome:

Blood biochemical

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血、尿常规

指标类型:

主要指标 

Outcome:

blood and urine routine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 65 years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

不适用

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

研究结束后,为保障病人隐私,原始数据将在研究中心封存

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

After the study, in order to protect patient privacy, the initial data will be stored in the research center

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:

原始数据将密封保存,制作电子数据,保存在2台不同电脑

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Initial data will be sealed to preserve, and we will make the electronic data. The electronic data shoulded be stored in 2 different computers

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-08-01
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