今天是:2017-04-26 星期三

太极拳运动对缺血性脑卒中高危人群高危因素及心肺功能改善效果的随机对照研究
下载XML文档

注册号:

Registration number:

ChiCTR-TRC-13003601 

最近更新日期:

Date of Last Refreshed on:

2016-03-11 

注册时间:

Date of Registration:

2013-07-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

太极拳运动对缺血性脑卒中高危人群高危因素及心肺功能改善效果的随机对照研究 

Public title:

Tai Chi for the cardiopulmonary function and relative risk factors of ischemic stroke in community older population:a randomized controlled study 

研究课题的正式科学名称:

太极拳运动对缺血性脑卒中高危人群高危因素及内脏功能改善效果的随机对照研究 

Scientific title:

Tai Chi for the cardiopulmonary function and relative risk factors of ischemic stroke in community older population:a randomized controlled study 

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:

郑欣、李俊喆 

研究负责人:

郑国华、陈立典 

Applicant:

Xin Zheng, JunZhe Li 

Study leader:

Guohua Zheng, Lidian Chen 

申请注册联系人电话:

Applicant telephone:

+86 15280031733 

研究负责人电话:

Study leader's telephone:

+86 13290802149 

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:

zhengxin123366816@126.com 

研究负责人电子邮件:

Study leader's E-mail:

zhgh_1969@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):

 

申请注册联系人通讯地址:

福建省福州市闽侯县上街华佗路1号 

研究负责人通讯地址:

福建省福州市闽侯县上街华佗路1号 

Applicant address:

1 Huatuo Road, Minhou Shangjie, Fuzhou, Fujian, China 

Study leader's address:

1 Huatuo Road, Minhou Shangjie, Fuzhou, Fujian, China 

申请注册联系人邮政编码:

Applicant postcode:

350108 

研究负责人邮政编码:

Study leader's postcode:

350108 

申请人所在单位:

福建中医药大学康复医学院 

Applicant's institution:

The Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine 

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:

2013-020-02 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

福建中医药大学附属人民医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of The Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-08 

研究实施负责(组长)单位:

国家中医药管理局中医康复研究中心 

Primary sponsor:

Traditional Chinese Medicine Rehabilitation Research Center of State Administration of Traditional Chinese Medicine of the People's Republic of China 

研究实施负责(组长)单位地址:

福建省福州市闽侯县上街华佗路1号 

Primary sponsor's address:

1 Huatuo Road, Minhou Shangjie, Fuzhou, Fujian, 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):

福建

市(区县):

福州

Country:

China

Province:

Fujian

City:

Fuzhou

单位(医院):

福建中医药大学

具体地址:

福州闽侯上街华佗路1号

Institution
hospital:

Fujian university of traditional Chinese medicine

Address:

1 Huatuo Road, Minhou Shangjie, Fuzhou, Fujian, China

经费或物资来源:

福建中医药大学 

Source(s) of funding:

Fujian University of Traditional Chinese Medicine 

研究疾病:

缺血性脑卒中 

Target disease:

Ischemic stroke 

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:

其它 

Study phase:

Other 

研究目的:

采取严格的随机对照研究设计,系统评价太极拳运动对社区缺血性脑卒中高危老年人群心肺功能、脑血管功能及脑卒中危险因素的改善效果,为推广太极拳运动预防脑卒中提供有力的证据。 

Objectives of Study:

We will perform a rigorous randomized controlled trial to systematically evaluate the effect of Tai Chi for the cariopulmonary function, cerebrovascular function and risk factor of ischemic stroke in community elderly population. The aim is to provide a powerful evidence of Tai Chi for primary prevention of stroke. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

1、符合脑卒中高危人群的判断标准; 2、近1年内未进行经常性体育锻炼(经常性体育锻炼的标准是每周锻炼≥3 次、每次≥30 分钟、持续时间超过3个月); 3、年龄:55-70岁;  4、知情同意,自愿参加。 符合以上标准者,可纳入研究。 

Inclusion criteria

1. Confirmed diagnosis of high risk groups of stroke in accordance with diagnostic criteria published by ministry of Health P.R. China; 2. Nearly 1 year not taking regular physical exercise (the standard of regular physical exercise is exercise for 30 minutes or more at a time, three times or more every week, lasting more than 3 months); 3. An age of 55 to 70 years; 4. Informed consent and voluntary to participate in;Meeting the above criteria simultaneously can be incorporated into the study. 

排除标准:

1、既往有脑卒中史者: 2、患有严重脏器衰竭、严重的心脑血管疾病、肌肉骨骼系统疾病以及其他运动禁忌症而不适宜进行太极拳运动者; 3、交流障碍者,如痴呆、精神异常等。 符合以上任何一条标准者,不予纳入研究。 

Exclusion criteria:

1. Having a history of stroke; 2. With severe organ failure, serious heart and cerebrovascular diseases, diseases of the musculoskeletal system and other contraindications that are not suitable for tai chi movement; 3. Communication disorder, such as dementia, mental disorder, etc.; Meeting any of the above criteria should not be included in the study. 

研究实施时间:

Study execute time:

From2013-10-01To 2015-09-30 

干预措施:

Interventions:

组别:

太极拳运动组

样本量:

85

Group:

Tai Chi exercise group

Sample size:

干预措施:

太极拳运动

干预措施代码:

Intervention:

tai chi

Intervention code:

组别:

对照组

样本量:

85

Group:

Control group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

福建 

市(区县):

福州 

Country:

China 

Province:

Fujian 

City:

Fuzhou 

单位(医院):

国家中医药管理局中医康复研究中心 

单位级别:

 

Institution
hospital:

Traditional Chinese Medicine Rehabilitation Research Center of State Administration of Traditional Chinese Medicine of the People's Republic of China  

Level of the institution:

 

国家:

中国 

省(直辖市):

福建 

市(区县):

福州 

Country:

China 

Province:

Fujian 

City:

Fuzhou 

单位(医院):

福建中医药大学附属康复医院 

单位级别:

专科医院 

Institution
hospital:

The Affiliated Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine  

Level of the institution:

Special hospital 

国家:

中国 

省(直辖市):

福建 

市(区县):

福州 

Country:

China 

Province:

Fujian 

City:

Fuzhou 

单位(医院):

五凤社区 

单位级别:

社区中心 

Institution
hospital:

Wufeng community center  

Level of the institution:

Community center 

国家:

中国 

省(直辖市):

福建 

市(区县):

福州 

Country:

China 

Province:

Fujian 

City:

Fuzhou 

单位(医院):

五凤社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Wufeng Community Medical Service Center  

Level of the institution:

Comunity Medical Service Center 

测量指标:

Outcomes:

指标中文名:

脑血管功能

指标类型:

主要指标 

Outcome:

Cerebrovascular function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心肺功能

指标类型:

主要指标 

Outcome:

Cardiopulmonary function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血脂

指标类型:

主要指标 

Outcome:

blood lipids

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

主要指标 

Outcome:

blood glucose

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

同型半胱氨酸

指标类型:

主要指标 

Outcome:

homocystein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

本体功能

指标类型:

次要指标 

Outcome:

Ontology function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

平衡能力

指标类型:

次要指标 

Outcome:

Balance control

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体质指标参数

指标类型:

次要指标 

Outcome:

Physical fitness parameters

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睡眠质量

指标类型:

次要指标 

Outcome:

Pittsburgh Sleep Quality Index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量

指标类型:

次要指标 

Outcome:

SF-36

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

POM

指标类型:

次要指标 

Outcome:

POM

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:

标本中文名:

血液

组织:

Sample Name:

Blood

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 55 years
最大 Max age 70 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):

循证医学中心采用SAS9.1软件中的PLAN语句生成随机序列

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

The random sequence are produced with PLAN statements of SAS 9.1 software by Center for Evidence-b

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):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

国家中医药管理局中医康复研究中心

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

Traditional Chinese Medicine Rehabilitation Research Center of State Administration of Traditional Chinese Medicine of the People's Republic of China

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

福建中医药大学中西医结合研究院循证医学中心

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Center for Evidence-based Chinese Medicine, Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine

注册人:

Name of Registration:

 2013-07-23
返回列表