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Effects of Swiss ball balance training on arterial stiffness and heart rate variability in young and middle-aged adults
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注册号:

Registration number:

ChiCTR2200055940 

最近更新日期:

Date of Last Refreshed on:

2022-01-27 

注册时间:

Date of Registration:

2022-01-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

瑞士球平衡训练对青年和中老年人动脉硬度和心率变异性的影响 

Public title:

Effects of Swiss ball balance training on arterial stiffness and heart rate variability in young and middle-aged adults 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

瑞士球平衡训练对青年和中老年人动脉硬度和心率变异性的影响 

Scientific title:

Effects of Swiss ball balance training on arterial stiffness and heart rate variability in young and middle-aged adults 

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:

朱蔚莉 

研究负责人:

朱蔚莉 

Applicant:

Weili Zhu 

Study leader:

Weili Zhu 

申请注册联系人电话:

Applicant telephone:

010-82099063 

研究负责人电话:

Study leader's telephone:

010-82099063 

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:

weili_zhu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

weili_zhu@163.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:

北京市海淀区北三环西路11号 

研究负责人通讯地址:

北京市海淀区北三环西路11号 

Applicant address:

11 Bei San Huan Xi Road, Haidian District, Beijing 

Study leader's address:

11 Bei San Huan Xi Road, Haidian District, Beijing 

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:

首都体育学院 

Applicant's institution:

Capital University of Physical Education and Sports 

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:

2022A04 

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:

首都体育学院伦理道德专门委员会 

Name of the ethic committee:

Ethics Committee of Capital University of Physical Education and Sports  

伦理委员会批准日期:

Date of approved by ethic committee:

2022-01-12 

伦理委员会联系人:

付全 

Contact Name of the ethic committee:

Quan Fu 

伦理委员会联系地址:

北京市海淀区北三环西路11号 

Contact Address of the ethic committee:

11 Bei San Huan Xi Road, Haidian District, Beijing 

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:

首都体育学院 

Primary sponsor:

Capital University of Physical Education and Sports 

研究实施负责(组长)单位地址:

北京市海淀区北三环西路11号 

Primary sponsor's address:

11 Bei San Huan Xi Road, Haidian District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都体育学院

具体地址:

北京市海淀区北三环西路11号

Institution
hospital:

Capital University of Physical Education and Sports

Address:

11 Bei San Huan Xi Road, Haidian District, Beijing

经费或物资来源:

自筹 

Source(s) of funding:

Self-funded 

研究疾病:

心血管健康 

Target disease:

cardiovascular health 

研究疾病代码:

 

Target disease code:

 

研究类型:

预防性研究 

Study type:

Prevention 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

探究瑞士球平衡训练对对青年和中老年人动脉硬度和心率变异性的影响及其相关机制 

Objectives of Study:

To investigate the effects of Swiss ball balance training on arterial stiffness and heart rate variability and related mechanism in young and middle-aged adults  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机交叉对照 

Study design:

Cross-over 

纳入标准:

①年龄18周岁以上; ②受试者无器官疾病史和药物过敏史,无药物滥用和嗜烟嗜酒史; ③体格检查及实验室检查、12导联心电图和生命体征检查经研究者判定为健康受试者; ④试验2周前未使用过任何处方药、非处方药和中成药。 

Inclusion criteria

①over 18 years of age; ②The subject has no history of organ disease and drug allergy, no history of drug abuse, smoking or alcoholism; ③Physical examination, laboratory examination, 12-lead electrocardiogram and vital signs examination were judged as healthy subjects by the researcher; ④No prescription drugs, over-the-counter drugs, or proprietary Chinese medicines were used 2 weeks before the test. 

排除标准:

①对波生坦或其辅料中任何成分过敏者,或者服用维生素C(VC),维生素E等抗氧化药物; ②筛选前6个月和试验期间吸烟、酗酒,过量饮用浓茶、咖啡及含咖啡因的饮料; ③筛选前6个月内有处方药物滥用史和非法药物滥用史; ④正参加其它临床试验的受试者; ⑤研究人员认为其他原因不适合临床试验者。 

Exclusion criteria:

① Those who are allergic to bosentan or any ingredients in its excipients, or take vitamin C (VC), vitamin E and other antioxidant drugs; ② Smoking, alcohol abuse, excessive drinking of strong tea, coffee and caffeinated beverages during the 6 months before screening and during the trial; ③Have a history of prescription drug abuse and illegal drug abuse within 6 months before screening; ④ Subjects who are participating in other clinical trials; ⑤ Researchers believe that other reasons are not suitable for clinical trials. 

研究实施时间:

Study execute time:

From2022-02-01To 2022-12-30 

征募观察对象时间:

Recruiting time:

From2022-02-01To 2022-02-28 

干预措施:

Interventions:

组别:

4

样本量:

22

Group:

four

Sample size:

干预措施:

瑞士球上不同姿势维持平衡

干预措施代码:

Intervention:

Maintain balance in different postures on the Swiss ball

Intervention code:

组别:

2

样本量:

40

Group:

two

Sample size:

干预措施:

瑞士球上维持平衡

干预措施代码:

Intervention:

Balance on the Swiss ball

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都体育学院 

单位级别:

高等院校 

Institution
hospital:

Capital University of Physical Education and Sports  

Level of the institution:

university 

测量指标:

Outcomes:

指标中文名:

心-踝血管指数

指标类型:

主要指标 

Outcome:

Cardio-ankle vascular 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:

心率变异性

指标类型:

主要指标 

Outcome:

heart rate variability

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

一氧化氮

指标类型:

主要指标 

Outcome:

Nitric oxide

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

皮内素-1

指标类型:

主要指标 

Outcome:

endothelin-1

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

活性氧簇

指标类型:

主要指标 

Outcome:

ROS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超氧化物歧化酶

指标类型:

主要指标 

Outcome:

SOD

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

丙二醛

指标类型:

主要指标 

Outcome:

MDA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总抗氧化能力

指标类型:

主要指标 

Outcome:

TAC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

谷胱甘肽过氧化物酶

指标类型:

主要指标 

Outcome:

GPX

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:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

实验人员用计算软件产生随机数进行随机分组。

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

The experimenters used computing software to generate random numbers for random grouping.

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):

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):

国家人口健康科学数据中心:https://www.ncmi.cn/

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

National Population Health Data Center:https://www.ncmi.cn/

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:

通过电子采集和管理系统

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

Through the electronic acquisition and management system

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-01-27
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