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基于小组和家庭练习的太极项目在改善冠心病患者身体机能、心理社会健康中的应用
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注册号：

Registration number：

 ChiCTR-IIC-17013986 

最近更新日期：

Date of Last Refreshed on：

 2017-12-16 15:44:21 

注册时间：

Date of Registration：

 2017-12-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于小组和家庭练习的太极项目在改善冠心病患者身体机能、心理社会健康中的应用

Public 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 Pilot Randomized Controlled Trial

注册题目简写：

English Acronym：

A mixed Tai Chi Program for coronary heart disease

研究课题的正式科学名称：

基于小组和家庭练习的太极项目在改善冠心病患者身体机能、心理社会健康中的应用

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 Pilot Randomized Controlled Trial

研究课题代号(代码)：

Study subject ID：

 CREC Ref.No. 2017.353-T

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：

CUHK_CCRB00572

申请注册联系人：

Ting LIU 

研究负责人：

Ting LIU 

Applicant：

Ting LIU 

Study leader：

Ting LIU 

申请注册联系人电话：

Applicant telephone：

 +852 3943 9909

研究负责人电话：

Study leader's
telephone：

+852 3943 9909

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)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/500

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/500

申请注册联系人通讯地址：

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

研究负责人通讯地址：

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

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, China

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：

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

Applicant's institution：

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

研究负责人所在单位：

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

Affiliation of the Leader：

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：

 CREC Ref. No. 2017.353-T

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：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2017-09-29 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：

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

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：

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

Primary sponsor's address：

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

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Not applicable

Source(s) of funding：

Not applicable

研究疾病：

冠心病  

Target disease：

coronary heart disease

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：

横断面 

Study design：

Cross-sectional 

研究目的：

基于小组和家庭练习的太极项目在改善冠心病患者身体机能、心理社会健康中的应用  

Objectives of 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: A Pilot Randomized Controlled Trial

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) will have cardiac surgery planned during the following 6 months;
(2) presence of unstable angina, severe congestive heart failure or severe pulmonary disease;
(3) suffered from severe cognitive or sensory impairment (Abbreviated Mental Test score < 7)
(4) have difficulty or inability to walk, or other incapacitating disabilities that may limit the practice of Tai Chi;
(5) have previous training and practiced TC, or participated in other formal physical activity, within six months prior to the commencement of study.

Exclusion criteria：

(1) will have cardiac surgery planned during the following 6 months;
(2) presence of unstable angina, severe congestive heart failure or severe pulmonary disease;
(3) suffered from severe cognitive or sensory impairment (Abbreviated Mental Test score < 7)
(4) have difficulty or inability to walk, or other incapacitating disabilities that may limit the practice of Tai Chi;
(5) have previous training and practiced TC, or participated in other formal physical activity, within six months prior to the commencement of study.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-12-20 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 20

Group：

Two groups

Sample size：

干预措施：

Simplified 24-form Tai Chi, 60 min/session, 12 weeks, Tai Chi session 2/week for the first two-week, 3/week for the second two-week, and 4/week for the th versus usual care and non-exercise community activities

干预措施代码：

Intervention：

Simplified 24-form Tai Chi, 60 min/session, 12 weeks, Tai Chi session 2/week for the first two-week, 3/week for the second two-week, and 4/week for the th versus 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)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

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

单位级别：

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

Institution
hospital：

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

Level of the institution：

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

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：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

测量方法：

senior fitness tests：(a) two-minute step test to assess aerobic endurance; (b) chair stand test to evaluate leg strength; (c) chair sit-and-reach stand test to assess leg flexibility; (d) one-leg stand test to examine the stationary balance; (e) 8-foot-and-go test to assess the dynamic balance

Measure time point of outcome：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

Measure method：

senior fitness tests：(a) two-minute step test to assess aerobic endurance; (b) chair stand test to evaluate leg strength; (c) chair sit-and-reach stand test to assess leg flexibility; (d) one-leg stand test to examine the stationary balance; (e) 8-foot-and-go test to assess the dynamic balance

指标中文名：

Feasibility

指标类型：

次要指标

Outcome：

Feasibility

Type：

Secondary indicator

测量时间点：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

测量方法：

including drop-out rate, attendance at class and individual home-based TC practice

Measure time point of outcome：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

Measure method：

including drop-out rate, attendance at class and individual home-based TC practice

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：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

测量方法：

using Chinese Perceived Stress Scale

Measure time point of outcome：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

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：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

测量方法：

using the Centre for Epidemiological Studies of Depression

Measure time point of outcome：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

Measure method：

using the Centre for Epidemiological Studies of Depression

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：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

测量方法：

using Interpersonal Support Evaluation List

Measure time point of outcome：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

Measure method：

using Interpersonal Support Evaluation List

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：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

测量方法：

using the 12-item Short Form Health Survey

Measure time point of outcome：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

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：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

测量方法：

using the Chinese version of the self-efficacy for exercise and Tai Chi exercise self-efficacy

Measure time point of outcome：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

Measure method：

using the Chinese version of the self-efficacy for exercise and Tai Chi exercise self-efficacy

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：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

测量方法：

After an 8- to 10-h fasting, blood samples will be taken by using a finger-stick for the following measurements using autoanalyzers: blood lipid profiles and fasting blood sugar. BMI will be calculated as weight (kg) divided by the square of height (m). BF% could be calculated by a body fat monitor

Measure time point of outcome：

baseline (T0), 6 weeks (post group-based intervention) (T1), and 12 weeks (post-intervention) (T2)

Measure method：

After an 8- to 10-h fasting, blood samples will be taken by using a finger-stick for the following measurements using autoanalyzers: blood lipid profiles and fasting blood sugar. BMI will be calculated as weight (kg) divided by the square of height (m). BF% could be calculated by a body fat monitor

采集人体标本：

Collecting sample(s)
from participants：

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 岁 years
最大 Max age 90 岁 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）：

Randomized parallel control experiments

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

Randomized parallel control experiments

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

否No

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）：

Not stated

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

Not stated

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：

Not stated

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2017-12-16 15:44:21
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