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Comparative effects of Yi Jin Jing versus Tai Chi exercise training on benign prostatic hyperplasia-related outcomes in older adults: study protocol for a randomized controlled trial
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注册号:

Registration number:

ChiCTR-IOR-16007698 

最近更新日期:

Date of Last Refreshed on:

2016-02-06 

注册时间:

Date of Registration:

2016-01-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

比较易筋经运动与太极拳运动对老年男性前列腺增生相关结果的影响:随机对照研究方案 

Public title:

Comparative effects of Yi Jin Jing versus Tai Chi exercise training on benign prostatic hyperplasia-related outcomes in older adults: study protocol for a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

运动健身改善老年人体质的生物信息综合评估系统研究 

Scientific title:

Research on the comprehensive evaluation system of physical fitness of the aged people with physical exercise 

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:

刘向云 

研究负责人:

刘向云 

Applicant:

Liu Xiang Yun 

Study leader:

Liu Xiang Yun 

申请注册联系人电话:

Applicant telephone:

+86 13764053378 

研究负责人电话:

Study leader's telephone:

+86 13764053378 

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:

h6yf@163.com 

研究负责人电子邮件:

Study leader's E-mail:

h6yf@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:

中国上海市杨浦区恒仁路188号 

研究负责人通讯地址:

中国上海市杨浦区恒仁路188号 

Applicant address:

188 Hengren Road, Yangpu District, Shanghai, China 

Study leader's address:

188 Hengren Road, Yangpu District, Shanghai, 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:

上海体育学院 

Applicant's institution:

Shanghai University of 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:

[上体]伦审字(201003)号 

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:

上海体育学院科学研究伦理委员会 

Name of the ethic committee:

Scientific research ethics committee of Shanghai University of Sports 

伦理委员会批准日期:

Date of approved by ethic committee:

 

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:

上海体育学院 

Primary sponsor:

Shanghai University of Sports 

研究实施负责(组长)单位地址:

中国上海市杨浦区恒仁路188号 

Primary sponsor's address:

188 Hengren Road, Yangpu District, Shanghai, 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):

上海市

市(区县):

杨浦区

Country:

China

Province:

Shanghai

City:

Yangpu

单位(医院):

上海体育学院

具体地址:

上海市杨浦区恒仁路188号科研楼417室

Institution
hospital:

Shanghai University of Sports

Address:

Room 417, Research Building, 188 Hengren Road, Shanghai

经费或物资来源:

上海市科学研究委员会 

Source(s) of funding:

Shanghai science and Technology Commission 

研究疾病:

良性前列腺增生 

Target disease:

benign prostate hyperplasia 

研究疾病代码:

A18.111+ 

Target disease code:

A18.111+ 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

探讨长期易筋经运动对老年男性前列腺体积的影响,初步阐明运动防治良性前列腺增生的机理 

Objectives of Study:

To investigate the effects of long-term Yi Jin Jing exercise for older men with prostate volume, preliminary clarify the mechanism of exercise control benign prostatic hyperplasia. 

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) 年龄60-70; 2) 过去6个月体重变化不超过2%; 3) 过去3个月是久坐不动的生活方式或者无运动锻炼或者每周偶尔锻炼不到一次,每次20分钟; 4)过去3个月没有易筋经和/或者太极拳运动; 5)最近6个月期间没有无心血管疾病,没有服用与BPH相关的药物或者其他治疗; 6)志愿参入本研究6个月,并提供书面知情同意书。 

Inclusion criteria

1) an age of between 60 to 70 years; 2) a relatively stable body weight over the past six months with the weight change less than 2%; 3) a sedentary life or no exercise for the past three months, or having exercise occasionally with less than one time a week and 20 minutes each time; 4) no training experience for Yi Jin Jing and/or Tai Chi in past three months; 5) apparently healthy, free of cardiovascular diseases, and no treatment with the BPH drugs or other therapies during recent six months; and 6) voluntary participation in this research for at least 6 months and provision of written informed consent. 

排除标准:

1)有下列疾病标志和症状或者有疾病但不被限制的,包括克罗恩病、结节病、慢性腹泻、心脏病、类风湿关节炎、系统性红斑狼疮(SLE),和癌症; 2)在过去的六个月正在服用相关药物,如胰岛素依赖型糖尿病(IDDM)和抗生素; 3)排除与研究目的有任何冲突的因素。 

Exclusion criteria:

1) signs and symptoms of the following diseases or having the diseases, but not limited to, including Crohns disease, sarcoidosis, chronic diarrhea, heart disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), and cancer; 2) currently taking the relevant drugs, such as insulin-dependent diabetes mellitus (IDDM) and antibiotics, in the last six months; and 3) any conflict to the objectives of this study. 

研究实施时间:

Study execute time:

From2016-02-15To 2016-12-31 

征募观察对象时间:

Recruiting time:

From2016-02-18To 2016-10-18 

干预措施:

Interventions:

组别:

3

样本量:

150

Group:

three

Sample size:

干预措施:

运动干预

干预措施代码:

Intervention:

Exercise intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海市 

市(区县):

杨浦区 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海体育学院 

单位级别:

省级单位 

Institution
hospital:

Shanghai university of sports  

Level of the institution:

Provincial units 

测量指标:

Outcomes:

指标中文名:

前列腺体积

指标类型:

主要指标 

Outcome:

prostate volume

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:

前列腺

组织:

前列腺

Sample Name:

prostate

Tissue:

prostate

人体标本去向

其它 

说明

Fate of sample:

Others 

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 60 years
最大 Max age 70 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

由陈廷将B超检测的参入者的前列腺体积数据输入Excel表,用随机数字表产生随机序列,然后用随机平行对照试验法进行研究。

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

Input the incorporation of prostate volume data into excel table by B ultrasound detected By Chen ting ,and generated random sequence with the random number table, and then study which will be used by random parallel control test method in the paper.

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

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):

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

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:

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-01-04
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