衡阳市老年人群肌少症的流行病学调查

注册号:

Registration number:

ChiCTR1800019746 

最近更新日期:

Date of Last Refreshed on:

2018-11-26 19:39:30 

注册时间:

Date of Registration:

2018-11-26 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

衡阳市老年人群肌少症的流行病学调查

Public title:

Epidemiological survey of sarcopenia in the older people in Hengyang City

注册题目简写:

English Acronym:

研究课题的正式科学名称:

衡阳市老年人群肌少症的流行病学调查

Scientific title:

Epidemiological survey of sarcopenia in the older people in Hengyang City

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:

肖豪 

研究负责人:

周君 

Applicant:

Xiao Hao 

Study leader:

Zhou Jun 

申请注册联系人电话:

Applicant telephone:

+86 13786497417

研究负责人电话:

Study leader's
telephone:

+86 13575239169

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:

xhao424033@qq.com

研究负责人电子邮件:

Study leader's E-mail:

zhoujun8005@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:

湖南省衡阳市石鼓区船山路69号

研究负责人通讯地址:

湖南省衡阳市石鼓区船山路69号

Applicant address:

69 Chuanshan Road, Hengyang, Hu'nan, China

Study leader's address:

69 Chuanshan Road, Hengyang, Hu'nan, China

申请注册联系人邮政编码:

Applicant postcode:

421000

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

南华大学附属第一医院康复医学科

Applicant's institution:

Department of Rehabilitation Medicine, The First Affiliated Hospital of University of South China

研究负责人所在单位:

南华大学附属第一医院康复医学科

Affiliation of the Leader:

Department of Rehabilitation Medicine, The First Affiliated Hospital of University of South China

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

20181122

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:

南华大学附属第一医院伦理委员会

Name of the ethic committee:

Ethical Committee in the First Affiliated Hospital of University of South China

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-22 00:00:00

伦理委员会联系人:

凌洪

Contact Name of the ethic committee:

Ling Hong

伦理委员会联系地址:

湖南省衡阳市石鼓区船山路69号

Contact Address of the ethic committee:

69 Chuanshan Road, Hengyang, Hu'nan, 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:

南华大学附属第一医院康复医学科

Primary sponsor:

Department of Rehabilitation Medicine, The First Affiliated Hospital of University of South China

研究实施负责(组长)单位地址:

湖南省衡阳市石鼓区船山路69号

Primary sponsor's address:

69 Chuanshan Road, Hengyang, Hu'nan, 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):

湖南

市(区县):

Country:

China

Province:

Hu'nan

City:

单位(医院):

南华大学附属第一医院康复医学科

具体地址:

湖南省衡阳市石鼓区船山路69号

Institution
hospital:

Department of Rehabilitation Medicine, The First Affiliated Hospital of University of South China

Address:

69 Chuanshan Road, Hengyang, Hu'nan, China

经费或物资来源:

自筹

Source(s) of funding:

Self-funded

研究疾病:

衡阳市老年人群肌少症的流行病学调查  

Target disease:

Epidemiological survey of sarcopenia in the older people in Hengyang City

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:

其它 

Study phase:

N/A

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

调查湖南省衡阳市老年人群肌少症的患病率  

Objectives of Study:

Investigation of the prevalence of sarcopeniain in the older people in Hengyang City, Hunan Province

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1)与测试人员不配合,不能完成问卷调查或者拒绝签署知情同意;

2)不能完成握力测试和6m-步行速度测试;

3)不能独自站立或体内有起搏器、心脏支架等不能进行体成分测试。

Exclusion criteria:

1) failure to cooperate with the tester,cannot complete the questionnaire or refuse to sign the informed consent;
2) unable to finish grip test and the 6m-walking speed test;
3) who can not stand alone or failure to test for body composition because of the pacemakers, heart stents, etc.

研究实施时间:

Study execute time:

From 2018-12-01 00:00:00 To 2023-12-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2018-12-01 00:00:00 To 2023-12-01 00:00:00

干预措施:

Interventions:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

湖南 

市(区县):

 

Country:

China

Province:

Hu'nan

City:

单位(医院):

南华大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of University of South China

Level of the institution:

Tertiary A hospital

测量指标:

Outcomes:

指标中文名:

肌肉质量

指标类型:

主要指标

Outcome:

muscle mass

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌肉力量

指标类型:

主要指标

Outcome:

muscle strength

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身体活动能力

指标类型:

主要指标

Outcome:

physical activity

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

跌倒情况

指标类型:

次要指标

Outcome:

fall situation

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

TUG起立走计时测试

指标类型:

次要指标

Outcome:

time up and go test; TUG

Type:

Secondary 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 60 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):

无。

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

No.

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:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

通过发表论文公开数据

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

Public the data by paper

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:

数据采集:病例记录表 数据管理:Access数据库

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

CRF and Access will be used for data collection and management.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-11-26 19:39:30