有氧运动对不同种族间心血管系统影响研究

注册号:

Registration number:

ChiCTR-IPR-15006684 

最近更新日期:

Date of Last Refreshed on:

2015-07-07 10:19:55 

注册时间:

Date of Registration:

2015-06-28 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

有氧运动对不同种族间心血管系统影响研究

Public title:

Racial Difference in Cardiovascular Response Following Aerobic Exercise

注册题目简写:

English Acronym:

研究课题的正式科学名称:

有氧运动对不同种族间心血管系统影响研究

Scientific title:

Racial Difference in Cardiovascular Response Following Aerobic Exercise

研究课题代号(代码):

Study subject ID:

美国国立卫生研究院IR01HL093249-01A1

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:

孙朋 

研究负责人:

Fernhall Bo 

Applicant:

Sun Peng 

Study leader:

Fernhall Bo 

申请注册联系人电话:

Applicant telephone:

+86 13816295402

研究负责人电话:

Study leader's
telephone:

+86 13816295402

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:

psun@tyxx.ecnu.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

pengsun81@gmail.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:

上海市东川路500号,华东师范大学 青少年健康评价与运动干预教育部重点实验室

研究负责人通讯地址:

美国伊利诺伊大学香槟校区南古德温大街906号

Applicant address:

Key Laboratory of Adolescent Health Assessment and Exercise Intervention, Ministry of Education, East China Normal University, 500 Dongchuan Road, Shanghai, China

Study leader's address:

906 South Goodwin Ave, Urbana, IL 61801 USA

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:

华东师范大学

Applicant's institution:

East China Normal University

研究负责人所在单位:

Affiliation of the Leader:

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:

10432

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:

伊利诺伊大学香槟分校的伦理审查委员会

Name of the ethic committee:

University of Illinois at Urbana-Champaign institutional review board

伦理委员会批准日期:

Date of approved by ethic committee:

2011-03-02 00:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

伦理委员会联系地址:

Contact Address of the ethic committee:

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:

伊利诺伊大学香槟校区

Primary sponsor:

University of Illinois at Urbana-Champaign

研究实施负责(组长)单位地址:

美国伊利诺伊大学香槟校区南古德温大街906号

Primary sponsor's address:

906 South Goodwin Ave, Urbana, IL 61801 USA

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

美国

省(直辖市):

伊利诺伊州

市(区县):

Country:

United States

Province:

IL

City:

单位(医院):

伊利诺伊大学香槟校区

具体地址:

美国伊利诺伊大学香槟校区南古德温大街906号

Institution
hospital:

University of Illinois at Urbana-Champaign

Address:

906 South Goodwin Ave, Urbana, IL 61801 USA

经费或物资来源:

美国国立卫生研究院,IR01HL093249-01A1

Source(s) of funding:

Nation Institute of Health of Health, IR01HL093249-01A1

研究疾病:

心血管健康  

Target disease:

Cariovascular Health

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:

I期临床试验 

Study phase:

1

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

该研究的主要目的是探讨有氧运动后健康的非洲裔美国人、美国白人和中国人的心血管系统的功能变化。  

Objectives of Study:

The main purpose of the proposed study is to examine an aspect of cardiovascular health in African Americans and white Americans and Chinese health individuals following aerobic exercise.

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:

高血压、心血管疾病、代谢疾病、吸烟史。

Exclusion criteria:

Hypertension, cardiovascular disease, metabolic disease, and smoking history

研究实施时间:

Study execute time:

From 2011-03-02 00:00:00 To 2013-10-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2011-03-02 00:00:00 To 2013-02-20 00:00:00

干预措施:

Interventions:

组别:

3

样本量:

90

Group:

30

Sample size:

干预措施:

有氧运动

干预措施代码:

Intervention:

aerobic exercise

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

美国

省(直辖市):

伊利诺伊州 

市(区县):

 

Country:

United States

Province:

IL

City:

单位(医院):

伊利诺伊大学香槟校区 

单位级别:

高校 

Institution
hospital:

University of Illinois at Urbana-Champaign

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

运动后低血压

指标类型:

主要指标

Outcome:

Post-exercise Hypotension

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:

标本中文名:

血压

组织:

Sample Name:

blood pressure

Tissue:

人体标本去向

使用后销毁  

说明

Fate of sample:

Destruction after use  

Note:

征募研究对象情况:

Recruiting status:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 40 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):

双盲

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

double blind

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:

Blinding:

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

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):

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

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:

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

注册人:

Name of Registration:

 2015-07-07 10:19:55