今天是:2019-07-21 星期日

不同有氧运动项目对甲基苯丙胺成瘾者药物戒断的效果对比及最佳运动项目的肠道菌群变化研究
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注册号:

Registration number:

ChiCTR1900024439 

最近更新日期:

Date of Last Refreshed on:

2019-07-12 

注册时间:

Date of Registration:

2019-07-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

不同有氧运动项目对甲基苯丙胺成瘾者药物戒断的效果对比及最佳运动项目的肠道菌群变化研究 

Public title:

Comparison of the effects of different aerobic exercise items on drug abstinence in methamphetamine addicts and the changes of intestinal microflora in the best exercise items 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

不同有氧运动项目对甲基苯丙胺成瘾者药物戒断的效果对比及最佳运动项目的肠道菌群变化研究 

Scientific title:

Comparison of the effects of different aerobic exercise items on drug abstinence in methamphetamine addicts and the changes of intestinal microflora in the best exercise items 

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:

廖帅雄 

研究负责人:

宋刚 

Applicant:

Liao Shuaixiong 

Study leader:

Song Gang 

申请注册联系人电话:

Applicant telephone:

+86 13018359719 

研究负责人电话:

Study leader's telephone:

+86 13028321422 

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:

1519189799@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

songgang77@qq.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:

重庆市北碚区西南大学体育学院 

研究负责人通讯地址:

重庆市北碚区西南大学体育学院 

Applicant address:

College of Physical Education, Southwest University, Beibei District, Chongqing 

Study leader's address:

College of Physical Education, Southwest University, Beibei District, Chongqing 

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:

西南大学体育学院 

Applicant's institution:

College of Physical Education, Southwest University 

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:

201905 

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:

西南大学医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Southwest University Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-07-09 

伦理委员会联系人:

吴宗辉 

Contact Name of the ethic committee:

Wu Zonghui 

伦理委员会联系地址:

重庆市北碚区西南大学医院 

Contact Address of the ethic committee:

Southwest University Hospital, Beibei District, Chongqing 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 13370707766 

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:

西南大学体育学院 

Primary sponsor:

College of physical Education, Southwest University 

研究实施负责(组长)单位地址:

重庆市北碚区西南大学体育学院 

Primary sponsor's address:

College of physical Education, Southwest University, Beibei District, Chongqing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆市

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

西南大学

具体地址:

北碚区

Institution
hospital:

Southwest university

Address:

Beibei District

经费或物资来源:

重庆市运动戒毒研究中心;国家体育总局体质评价与运动机能监控重点实验室 

Source(s) of funding:

Chongqing Research Center for Sports detoxification; Key Laboratory of physique Evaluation and Motor function Monitoring of the State General Administration of Sports 

研究疾病:

毒品成瘾 

Target disease:

Drug addiction 

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:

其它 

Study phase:

N/A 

研究目的:

1.探讨跳绳运动、动感单车运动和呼啦圈运动等不同有氧运动项目对药物成瘾者渴求度的影响,确立甲基苯丙胺成瘾者药物戒断的最佳有氧运动项目。 2.探究最佳有氧运动项目下甲基苯丙胺成瘾者肠道内变化显著的菌种,揭示运动性肠道菌群改善与药物戒断的相关性。 

Objectives of Study:

1. To explore the effects of different aerobic sports such as rope skipping, motor cycling and hula hoop exercise on the craving of drug addicts, and to establish the best aerobic exercise for drug abstinence of methamphetamine addicts. 2.To explore the bacteria with significant changes in the intestines of methamphetamine addicts under the best aerobic exercise, and to reveal the correlation between the improvement of exercise-induced intestinal flora and drug withdrawal. 

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 精神状态正常; 2 首次进行强制戒毒; 3 仅吸食冰毒一种毒品; 4 年龄在18—45周岁之间; 5 吸毒历史在5年以内; 6 文化程度在小学及以上; 7 智力评估分数在5分以上。 

Inclusion criteria

1 normal mental state; 2 compulsory detoxification for the first time; 3 use only one kind of methamphetamine; 4 aged between 18 and 45 years; 5 drug abuse history within 5 years; 6 education level in primary school and above; 7 intelligence assessment score above 5. 

排除标准:

1 脑部疾病史; 2 经过身体活动适应能力问卷(Physical Activity Readiness Questionnaire,PAR-Q)评估,因身体残疾或医疗问题阻止或禁止参加中等强度有氧运动。 

Exclusion criteria:

1 history of brain disease; 2 assessed by the physical adaptability questionnaire (Physical Activity Readiness Questionnaire,PAR-Q), physical disability or medical problems prevented or prohibited participation in moderate aerobic exercise. 

研究实施时间:

Study execute time:

From2019-08-01To 2020-01-01 

干预措施:

Interventions:

组别:

试验组1

样本量:

20

Group:

Experimental group 1

Sample size:

干预措施:

跳绳

干预措施代码:

E1

Intervention:

Jump rope

Intervention code:

组别:

试验组 2

样本量:

20

Group:

Experimental group 2

Sample size:

干预措施:

动感单车

干预措施代码:

E2

Intervention:

Spinning bicycle

Intervention code:

组别:

试验组 3

样本量:

20

Group:

Experimental group 3

Sample size:

干预措施:

呼啦圈

干预措施代码:

E3

Intervention:

Hula hoop

Intervention code:

组别:

对照组

样本量:

20

Group:

Control group

Sample size:

干预措施:

干预措施代码:

C

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆市 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆南岸女子强制隔离戒毒所 

单位级别:

强制隔离戒毒所 

Institution
hospital:

Chongqing South Bank Women's Compulsory Quarantine and Drug Addiction Center  

Level of the institution:

Compulsory Quarantine and Drug Addiction Center 

测量指标:

Outcomes:

指标中文名:

药物渴求度

指标类型:

主要指标 

Outcome:

Drug craving

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

情绪

指标类型:

主要指标 

Outcome:

Emotion

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道菌群

指标类型:

主要指标 

Outcome:

Intestinal flora

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:

粪便

组织:

大肠

Sample Name:

Feces

Tissue:

colon

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 18 years
最大 Max age 45 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

试验人员用随机表法产生随机序列。

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

The experimenter uses the random table method to generate the random sequence.

盲法:

open

Blinding:

open

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

公开时间:2020年4月1日; 网站:https://www.clinicaltrials.gov

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

Time: April 1, 2020; Website:https://www.clinicaltrials.gov

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:

数据采集:通过实验记录表采集;管理:转为电子表格储存。

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

Data acquisition: Collection through experimental recording tables;Management: Converted to spreadsheet storage.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-12
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