八段锦运动对慢性心衰患者健康干预的随机对照研究

注册号:

Registration number:

ITMCTR2200005717

最近更新日期:

Date of Last Refreshed on:

2022-03-15

注册时间:

Date of Registration:

2022-03-15

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

八段锦运动对慢性心衰患者健康干预的随机对照研究

Public title:

A Randomized Controlled Study on the Health Intervention of Duanjin Exercise on Patients with Chronic Heart Failure

注册题目简写:

English Acronym:

研究课题的正式科学名称:

八段锦运动对慢性心衰患者健康干预的随机对照研究

Scientific title:

A Randomized Controlled Study on the Health Intervention of Duanjin Exercise on Patients with Chronic Heart Failure

研究课题的正式科学名称简写:

Scientific title acronym:

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:

ChiCTR2200057606 ; ChiMCTR2200005717

申请注册联系人:

孙美侠

研究负责人:

庄贺

Applicant:

sunmeixia

Study leader:

zhuanghe

申请注册联系人电话:

Applicant telephone:

18133522642

研究负责人电话:

Study leader's telephone:

18678836978

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:

1598151743@qq.com

研究负责人电子邮件:

Study leader's E-mail:

529521283@qq.com

申请单位网址(自愿提供):

Study leader's 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:

山东省济南市长清区大学科技园大学路4655号

研究负责人通讯地址:

山东省济南市长清区大学科技园大学路4655号

Applicant address:

No.4655, University Road, University Science Park, Changqing District, Jinan City, Shandong Province

Study leader's address:

No.4655, University Road, University Science Park, Changqing District, Jinan City, Shandong Province

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:

山东中医药大学

Applicant's institution:

Shandong university of traditional Chinese medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

(2021)临床科研申报第(154)号)

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

山东中医药大学附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of Affiliated Hospital of Shandong University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2021/8/9 0:00:00

伦理委员会联系人:

陈柏楠

Contact Name of the ethic committee:

chenbonan

伦理委员会联系地址:

山东省济南市经十路16369号

Contact Address of the ethic committee:

No.16369, Jingshi Road, Jinan City, Shandong Province

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:

山东中药大学

Primary sponsor:

Shandong university of traditional Chinese medicine

研究实施负责(组长)单位地址:

山东省济南市长清区大学科技园大学路4655号

Primary sponsor's address:

No.4655, University Road, University Science Park, Changqing District, Jinan City, Shandong Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山东

市(区县):

Country:

China

Province:

Shandong

City:

单位(医院):

山东中医药大学附属医院

具体地址:

山东省济南市经十路16369号

Institution
hospital:

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Address:

No.16369, Jingshi Road, Jinan City, Shandong Province

经费或物资来源:

山东省中药管理局

Source(s) of funding:

Shandong Provincial Administration of Traditional Chinese Medicine

研究疾病:

慢性心力衰竭

研究疾病代码:

Target disease:

Chronic heart failure

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

I期临床试验

Phase I clinical trial

研究目的:

明确八段锦运动对CHF患者的心功能改善,探讨其临床有效性的作用靶点及可能作用机制,为八段锦运动对CHF患者康复疗效提供循证医学证据。

Objectives of Study:

To clarify the improvement of cardiac function of patients with CHF by Baduanjin exercise, explore the target and possible mechanism of its clinical effectiveness, and provide evidence-based medicine evidence for the rehabilitation effect of Baduanjin exercise on patients with CHF.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

①经检查确诊为冠心病患者,年龄45~70岁; ②均有心衰的临床表现,且多普勒彩色超声显示左心室射血分数(LVEF)低于50%;③患者心衰病情稳定,常规药物治疗能够缓解; ④患者非文盲,能够理解研究组人员给予的任何指令,服从安排; ⑤知情同意,签署知情同意书。

Inclusion criteria

① Patients diagnosed with coronary heart disease by examination, aged 45 ~ 70 years; ② All patients had clinical manifestations of heart failure, and Doppler color ultrasound showed that left ventricular ejection fraction (LVEF) was less than 50%; ③ The patient's heart failure is stable and can be alleviated by conventional drug treatment; ④ The patient is non-illiterate, can understand any instructions given by the research group and obey the arrangement; ⑤ Informed consent, sign informed consent form.

排除标准:

①伴严重的肝、肾、脑、肺等功能异常,有严重主动脉狭窄、严重心律失常、不稳定性心绞痛等; ②患者曾接受过心肺复苏或电除颤治疗,或安装有心脏起搏器; ③精神疾病未实施有效控制; ④恶性肿瘤; ⑤合并慢性阻塞性肺疾病(COPD)、未控制高血压、血糖者;⑥其他疾病或情况影响本次研究。

Exclusion criteria:

① With severe liver, kidney, brain and lung dysfunction, severe aortic stenosis, severe arrhythmia, unstable angina pectoris, etc. ② The patient has received cardiopulmonary resuscitation or electric defibrillation treatment, or has a pacemaker; ③ Mental illness has not been effectively controlled; ④ Malignant tumor; ⑤ Patients with chronic obstructive pulmonary disease (COPD), uncontrolled hypertension and blood sugar; ⑥ Other diseases or conditions affect this study.

研究实施时间:

Study execute time:

From 2021-11-01

To      2023-12-31

征募观察对象时间:

Recruiting time:

From 2022-03-31

To      2023-12-31

干预措施:

Interventions:

组别:

试验组 对照组

样本量:

72

Group:

Experimental group and control group

Sample size:

干预措施:

改良八段锦运动

干预措施代码:

Intervention:

Improved Baduanjin Sports

Intervention code:

样本总量 Total sample size : 72

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

山东济南

市(区县):

Country:

China

Province:

Jinan, Shandong province

City:

单位(医院):

山东中医药大学附属医院

单位级别:

省级

Institution/hospital:

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Level of the institution:

Provincial level

测量指标:

Outcomes:

指标中文名:

心功能指数

指标类型:

主要指标

Outcome:

cardiac function index

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清AngⅡ、Hcy、SOD、BNP浓度水平

指标类型:

主要指标

Outcome:

Serum AngⅡ ⅱ, Hcy, SOD, BNP concentration level

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:

正在进行

Recruiting

年龄范围:

最小
Min age years
最大
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

随机数字表

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

Random number table

盲法:

单盲(评估者盲)

Blinding:

single-blind (appraiser's blindness)

是否共享原始数据:

IPD sharing:

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):

EDC

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

EDC

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:

根据本课题研究计划方案,制定病例报告表(Case Report Form,CRF),并按时准确完成CRF的填写。应用SPSS25.0版软件进行数据录入,建立数据库。相关性分析采用Pearson相关性分析。计量资料用( )统计表示,计数资料用构成比统计表示,取P<0.05为差异具有统计学意义。

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

According to the research plan of this project, make a Case Report Form,CRF), and complete the CRF on time and accurately. Use SPSS25.0 software to enter data and establish a database. Pearson correlation analysis was used for correlation analysis. The measurement data is expressed by () statistics, and the counting data is expressed by composition ratio statistics, and the difference is statistically significant when p < 0.05.

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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