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Main study: Effects of a Group- plus Home-based Tai Chi Program on Improving Physical Function and Psychosocial Well-being in Patients with Coronary Heart Disease
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注册号:

Registration number:

ChiCTR1800015728 

最近更新日期:

Date of Last Refreshed on:

2018-04-17 

注册时间:

Date of Registration:

2018-04-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

Main study: Effects of a Group- plus Home-based Tai Chi Program on Improving Physical Function and Psychosocial Well-being in Patients with Coronary Heart Disease 

Public title:

Main study: Effects of a Group- plus Home-based Tai Chi Program on Improving Physical Function and Psychosocial Well-being in Patients with Coronary Heart Disease 

注册题目简写:

 

English Acronym:

A mixed Tai Chi program on CHD patients 

研究课题的正式科学名称:

Effects of a Group- plus Home-based Tai Chi Program on Improving Physical Function and Psychosocial Well-being in Patients with Coronary Heart Disease: A Randomized Controlled Trial  

Scientific title:

Effects of a Group- plus Home-based Tai Chi Program on Improving Physical Function and Psychosocial Well-being in Patients with Coronary Heart Disease: A Randomized Controlled Trial  

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:

劉婷 

研究负责人:

劉婷 

Applicant:

Ting LIU 

Study leader:

Ting LIU 

申请注册联系人电话:

Applicant telephone:

+852 6580 1740 

研究负责人电话:

Study leader's telephone:

+852 6580 1740 

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:

liuting@link.cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

liuting@link.cuhk.edu.hk 

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:

中國香港特別行政區香港中文大學那打素護理學院利黃瑤璧樓601室 

研究负责人通讯地址:

中國香港特別行政區香港中文大學那打素護理學院利黃瑤璧樓601室 

Applicant address:

Room 601, Esther Lee Building, The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong Special Administrative Region, China 

Study leader's address:

Room 601, Esther Lee Building, The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong Special Administrative Region 

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:

香港中文大學那打素護理學院 

Applicant's institution:

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong 

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:

2017.353-T 

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:

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee 

Name of the ethic committee:

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-09-29 

伦理委员会联系人:

Envy Lee 

Contact Name of the ethic committee:

Envy Lee 

伦理委员会联系地址:

中國香港特別行政區新界沙田威爾士親王醫院呂志和臨床科學大樓8/F 

Contact Address of the ethic committee:

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+852 3505 3935 

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:

香港中文大學那打素護理學院 

Primary sponsor:

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

中國香港特別行政區香港中文大學那打素護理學院利黃瑤璧樓601室 

Primary sponsor's address:

Room 601, Esther Lee Building, The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong Special Administrative Region 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中國

省(直辖市):

香港特別行政區

市(区县):

Country:

China

Province:

Hong Kong Special Administrative Region

City:

单位(医院):

香港中文大學那打素護理學院

具体地址:

中國香港特別行政區香港中文大學那打素護理學院利黃瑤璧樓601室

Institution
hospital:

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

Address:

Room 601, Esther Lee Building, The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong Special Administrative Region

经费或物资来源:

This study does not have funding support. Principle investigator (PI) is a PhD student, and this study is the PhD project. the PI will not seek funding from any parties 

Source(s) of funding:

This study does not have funding support. Principle investigator (PI) is a PhD student, and this study is the PhD project. the PI will not seek funding from any parties 

研究疾病:

冠心病 

Target disease:

coronary heart disease (CHD)  

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+II期 

Study phase:

1-2 

研究目的:

The study aims to conduct a group- plus home-based Tai Chi program for patients with CHD, which will beneficial in improving physical and psychosocial well-being. 

Objectives of Study:

The study aims to conduct a group- plus home-based Tai Chi program for patients with CHD, which will beneficial in improving physical and psychosocial well-being. 

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 

Study design:

Parallel 

纳入标准:

(1) have been diagnosed with CHD; (2) age > 18 years old; (3) be able to communicate in Chinese; (4) do not participate in regular exercise (performed planned, structured physical activity at least 30 min at moderate intensity at least 3 d/week for at least 3 months). 

Inclusion criteria

(1) have been diagnosed with CHD; (2) age > 18 years old; (3) be able to communicate in Chinese; (4) do not participate in regular exercise (performed planned, structured physical activity at least 30 min at moderate intensity at least 3 d/week for at least 3 months). 

排除标准:

(1) Had been planned to under go cardiac surgery during the following 6 months; (2) presence of unstable angina, severe congestive heart failure or severe pulmonary disease; (3 )New York Heart Functional Classification IV; (4) have been diagnosed with anxiety, depression or other mental illness; or have active treatment for mental illness; (5) suffered from severe cognitive or sensory impairment (with the score of Abbreviated Mental Test lower than seven) (Sahadevan, Tan, & Chan, 2000); (6) have difficulty or inability to walk, or other incapacitating disabilities that may limit the practice of TC. 

Exclusion criteria:

(1) Had been planned to under go cardiac surgery during the following 6 months; (2) presence of unstable angina, severe congestive heart failure or severe pulmonary disease; (3 )New York Heart Functional Classification IV; (4) have been diagnosed with anxiety, depression or other mental illness; or have active treatment for mental illness; (5) suffered from severe cognitive or sensory impairment (with the score of Abbreviated Mental Test lower than seven) (Sahadevan, Tan, & Chan, 2000); (6) have difficulty or inability to walk, or other incapacitating disabilities that may limit the practice of TC. 

研究实施时间:

Study execute time:

From2018-04-24To 2019-04-24 

征募观察对象时间:

Recruiting time:

From2018-04-24To  

干预措施:

Interventions:

组别:

Tai Chi group

样本量:

49

Group:

Tai Chi group

Sample size:

干预措施:

Tai Chi exercise

干预措施代码:

Intervention:

Tai Chi exercise

Intervention code:

组别:

Control group

样本量:

49

Group:

Control group

Sample size:

干预措施:

usual care and non-exercise community activities

干预措施代码:

Intervention:

usual care and non-exercise community activities

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

山東 

市(区县):

濟南 

Country:

China 

Province:

Shandong 

City:

Ji'nan 

单位(医院):

社區衛生服務中心 

单位级别:

社區衛生服務中心 

Institution
hospital:

community health service center  

Level of the institution:

community health service center 

测量指标:

Outcomes:

指标中文名:

Physical function (leg strength, leg flexibility, aerobic endurance, dynamic balance, and stationary balance)

指标类型:

主要指标 

Outcome:

Physical function (leg strength, leg flexibility, aerobic endurance, dynamic balance, and stationary balance)

Type:

Primary indicator 

测量时间点:

测量方法:

using several senior fitness tests

Measure time point of outcome:

Measure method:

using several senior fitness tests

指标中文名:

Perceived stress

指标类型:

次要指标 

Outcome:

Perceived stress

Type:

Secondary indicator 

测量时间点:

测量方法:

using Chinese Perceived Stress Scale

Measure time point of outcome:

Measure method:

using Chinese Perceived Stress Scale

指标中文名:

Depression

指标类型:

次要指标 

Outcome:

Depression

Type:

Secondary indicator 

测量时间点:

测量方法:

using the Centre for Epidemiological Studies of Depression

Measure time point of outcome:

Measure method:

using the Centre for Epidemiological Studies of Depression

指标中文名:

Quality of Life

指标类型:

次要指标 

Outcome:

Quality of Life

Type:

Secondary indicator 

测量时间点:

测量方法:

using the 12-item Short Form Health Survey

Measure time point of outcome:

Measure method:

using the 12-item Short Form Health Survey

指标中文名:

Exercise self-efficacy

指标类型:

次要指标 

Outcome:

Exercise self-efficacy

Type:

Secondary indicator 

测量时间点:

测量方法:

using the Chinese version of the self-efficacy for exercise (SEE-C) and Tai Chi exercise self-efficacy

Measure time point of outcome:

Measure method:

using the Chinese version of the self-efficacy for exercise (SEE-C) and Tai Chi exercise self-efficacy

指标中文名:

Social support

指标类型:

次要指标 

Outcome:

Social support

Type:

Secondary indicator 

测量时间点:

测量方法:

using Interpersonal Support Evaluation List

Measure time point of outcome:

Measure method:

using Interpersonal Support Evaluation List

指标中文名:

Cardiovascular risk factors, inculding blood pressure (BP), blood lipid profile (total cholesterol, triglyceride, high-density lipoprotein and low-density lipoprotein), blood sugar, body mass index (BMI) and body fat percentage (BF%)

指标类型:

次要指标 

Outcome:

Cardiovascular risk factors, inculding blood pressure (BP), blood lipid profile (total cholesterol, triglyceride, high-density lipoprotein and low-density lipoprotein), blood sugar, body mass index (BMI) and body fat percentage (BF%)

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:

组织:

Sample Name:

Blood

Tissue:

finger tip blood

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 90 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):

Principle investigator will use the website "randomization.com" to generate the random number sequence, with the random block size is seven

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

Principle investigator will use the website "randomization.com" to generate the random number sequence, with the random block size is seven

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

After complete the trial, through the publication

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

After complete the trial, through the publication

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:

Confidentiality and anonymity will be maintained during the data collection, storage, analysis and reporting procedures. all the data will be stored in locked closet and destroyed five years after the study.

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

Confidentiality and anonymity will be maintained during the data collection, storage, analysis and reporting procedures. all the data will be stored in locked closet and destroyed five years after the study.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-04-17
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