今天是:2020-08-11 星期二

抗阻力量训练对成年男性血清维生素D浓度的影响:随机对照试验
下载XML文档

注册号:

Registration number:

ChiCTR2000030876 

最近更新日期:

Date of Last Refreshed on:

2020-03-16 

注册时间:

Date of Registration:

2020-03-16 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

抗阻力量训练对成年男性血清维生素D浓度的影响:随机对照试验 

Public title:

Effects of resistance training on serum 25(OH)D concentrations in young men: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

抗阻力量训练对成年男性血清维生素D浓度的影响:随机对照试验 

Scientific title:

Effects of resistance training on serum 25(OH)D concentrations in young men: 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:

马晓凯 

研究负责人:

曹振波 

Applicant:

Xiao-Kai Ma 

Study leader:

Zhen-Bo Cao 

申请注册联系人电话:

Applicant telephone:

+86 18521539175 

研究负责人电话:

Study leader's telephone:

+86 18317101562 

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:

maxkchn@163.com 

研究负责人电子邮件:

Study leader's E-mail:

caozb_edu@yahoo.co.jp 

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:

上海市杨浦区恒仁路200号 

研究负责人通讯地址:

上海市杨浦区长海路399号 

Applicant address:

200 Hengren Road, Yangpu District, Shanghai, China 

Study leader's address:

399 Changhai 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 Sport 

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:

2016001 

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:

Ethics Committee of Shanghai University of Sport 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-12-25 

伦理委员会联系人:

程蓉 

Contact Name of the ethic committee:

Rong Cheng 

伦理委员会联系地址:

上海市杨浦区长海路399号 

Contact Address of the ethic committee:

399 Changhai Road, Yangpu District, Shanghai, China 

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 Sport 

研究实施负责(组长)单位地址:

上海市杨浦区长海路399号 

Primary sponsor's address:

399 Changhai 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(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海体育学院

具体地址:

上海市杨浦区长海路399号

Institution
hospital:

Shanghai University of Sport

Address:

399 Chang Hai Road

经费或物资来源:

国家自然科学基金委员会 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

维生素D缺乏 

Target disease:

vitamin D deficiency 

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:

探索性研究/预试验 

Study phase:

研究目的:

探究抗阻力量训练是否可改善血清维生素D营养状态,是否与体成分的变化有关。 

Objectives of Study:

This study aimed to examine the effect of chronic resistance training on serum 25-hydroxyvitamin D [25(OH)D] concentrations and determine whether 25(OH)D concentration variations are influenced by body composition changes.  

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)19~39岁健康男性,无任何非传染性慢性疾病(糖尿病、心脏病骨代谢疾病等)病史及家族史,无任何肢体障碍; (2)非肥胖人群,BMI<28 kg/m2; (3)近半年内没有摄取任何维生素及矿物质元素补充剂的习惯; (4)近半年内无运动锻炼习惯; 

Inclusion criteria

(1) healthy male aged 19 to 39 with no medical history or family history of any noncommunicable chronic diseases (diabetes, heart disease, bone metabolism, etc.) and no physical disorders; (2) non-obese people, BMI<28 kg/m2; (3) have not taken any vitamin or mineral supplements in the past six months; (4) no exercise habit in the past six months; 

排除标准:

经常服用维生素D补充剂或使用防晒霜的参与者 

Exclusion criteria:

Participants using vitamin D supplements or sunscreen regularly were excluded. 

研究实施时间:

Study execute time:

From2016-03-21To 2016-06-23 

征募观察对象时间:

Recruiting time:

From2015-12-25To 2016-03-20 

干预措施:

Interventions:

组别:

抗阻力量训练组

样本量:

9

Group:

resistance training group

Sample size:

干预措施:

12周抗阻力量训练,12RM,1周3次

干预措施代码:

Intervention:

12 weeks of progressive resistance training, 12 repetitions maximum, 3 times a week

Intervention code:

组别:

对照组

样本量:

9

Group:

no-exercise control group

Sample size:

干预措施:

干预措施代码:

Intervention:

N

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(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海体育学院 

单位级别:

大学 

Institution
hospital:

Shanghai University of Sport  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

血清25羟基维生素D

指标类型:

主要指标 

Outcome:

Serum 25-hydroxyvitamin D

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌肉量

指标类型:

主要指标 

Outcome:

Muscle mass

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体脂率

指标类型:

主要指标 

Outcome:

Body fat percentage

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨密度

指标类型:

主要指标 

Outcome:

Bone mineral density

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中高强度身体活动水平

指标类型:

主要指标 

Outcome:

Moderate-vigorous physical activity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

日光照射时间

指标类型:

主要指标 

Outcome:

Sun exposure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清全段甲状旁腺激素

指标类型:

主要指标 

Outcome:

Serum intact Parathyroid Hormone

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清胰岛素样生长因子1

指标类型:

主要指标 

Outcome:

Serum Insulin-like Growth Factor-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:

血清成纤维细胞生长因子21

指标类型:

主要指标 

Outcome:

Serum Fibroblast growth factor 21

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

最大重复次数

指标类型:

主要指标 

Outcome:

Repetition Maximum

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身高

指标类型:

主要指标 

Outcome:

Height

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

主要指标 

Outcome:

Weight

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

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

独立于本项目的科研工作人员使用计算机生成随机数,然后排序并分组

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

The researcher working independently of this study used computers to generate random Numbers, then sorted and grouped them.

盲法:

Open label

Blinding:

Open label

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

试验完成6个月内公开,依托学校科研平台进行共享

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

The experimental datas will open within 6 months after the completion of the experiment. The scientific research data will be shared based on platform of schools.

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:

研究过程中所有数据均有固定人员采集,定期进行整理,监测数据完整及真实性,并分别录入Excel表格。

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

In the course of the study, all the data were collected by fixed stuff. The data were arranged regularly to monitor the integrity and authenticity of the data and to enter the EXCEL form respectively.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-03-16
返回列表