Today is 2020-12-01

Motion Modelling for Sedentary Behavior during the novel coronavirus pneumonia (COVID-19) pandemic: 10-min High Intensity Interval Training (HIIT) with Music Therapy (MT)
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注册号:

Registration number:

ChiCTR2000038256 

最近更新日期:

Date of Last Refreshed on:

2020-09-15 

注册时间:

Date of Registration:

2020-09-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型冠状病毒肺炎(COVID-19)疫情下干预久坐行为的建模:结合音乐疗法的10分钟高强度间歇性运动 

Public title:

Motion Modelling for Sedentary Behavior during the novel coronavirus pneumonia (COVID-19) pandemic: 10-min High Intensity Interval Training (HIIT) with Music Therapy (MT) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

MT结合HIIT干预久坐行为初期的效能分析 

Scientific title:

The efficiency to incipiently intervene sedentary behavior by HIIT with MT 

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:

刘佳伶 

研究负责人:

刘佳伶 

Applicant:

Liu Jialing 

Study leader:

Liu Jialing 

申请注册联系人电话:

Applicant telephone:

+86 18881737077 

研究负责人电话:

Study leader's telephone:

+86 18881737077 

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:

550785118@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

550785118@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:

中国四川省南充市顺庆区涪江路234号川北医学院 

研究负责人通讯地址:

中国四川省南充市顺庆区涪江路234号川北医学院 

Applicant address:

234 Fujiang Road, Shunqing District, Nanchong, Sichuan, China 

Study leader's address:

234 Fujiang Road, Shunqing District, Nanchong, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

637000 

研究负责人邮政编码:

Study leader's postcode:

637000 

申请人所在单位:

川北医学院 

Applicant's institution:

North Sichuan Medical College 

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:

NSMC2020(04) 

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:

川北医学院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of North Sichuan Medical College 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-05-06 

伦理委员会联系人:

邓世山 

Contact Name of the ethic committee:

Deng Shishan 

伦理委员会联系地址:

中国四川省南充市顺庆区涪江路234号 

Contact Address of the ethic committee:

234 Fujiang Road, Shunqing District, Nanchong, Sichuan, 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:

川北医学院 

Primary sponsor:

North Sichuan Medical College 

研究实施负责(组长)单位地址:

中国四川省南充市顺庆区涪江路234号 

Primary sponsor's address:

234 Fujiang Road, Shunqing District, Nanchong, Sichuan, 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):

四川省

市(区县):

南充市

Country:

China

Province:

Sichuan

City:

Nanchong

单位(医院):

川北医学院

具体地址:

中国四川省南充市顺庆区涪江路234号

Institution
hospital:

North Sichuan Medical College

Address:

234 Fujiang Road, Shunqing District

经费或物资来源:

中国国家级大学生创新创业训练计划 

Source(s) of funding:

the Innovation and Entrepreneurship Training Program for College Students of China 

研究疾病:

新型冠状病毒肺炎(COVID-19); 久坐行为 

Target disease:

Novel Coronavirus Pneumonia (COVID-19); Sedentary Behavior 

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:

在COVID-19疫情期间,欲构建一个针对久坐人群的低成本易行的HIIT模型,并通过检测生理代谢、神经行为、心理认知和体感评估来验证该模型的实用价值。 

Objectives of Study:

For sedentary people isolated indoors during COVID-19 epidemic, we want to construct a low-cost, feasible HIIT model whose practical value will be verified by detecting changes in physiological metabolism, neurobehavioral, psychological cognition, and somatosensory assessment. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

志愿者为健康的18-25岁的医学专业大学生,在疫情期间至少居家隔离4个月以上,且每天久坐时间不小于6小时 

Inclusion criteria

Medical student volunteers should be healthy and 18-25 years of age who have stayed at home at least 4 months. Sedentary time is not less than 6 hours per day. 

排除标准:

规律性进行运动锻炼者,患有严重的慢性病或有手术史,个人行程安排与实验时间相冲突者 

Exclusion criteria:

Do sports termly, severe chronic diseases or operation history, schedule conflict.  

研究实施时间:

Study execute time:

From2020-08-01To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2020-09-07To 2020-09-13 

干预措施:

Interventions:

组别:

Case series

样本量:

118

Group:

Case series

Sample size:

干预措施:

120分钟久坐学习+伴随音乐进行10分钟高强度间歇性运动 + 伴随音乐进行10分钟高强度间歇性运动

干预措施代码:

Intervention:

120-min sedentary task + 10-min HIIT with MT + 10-min HIIT with MT

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

南充 

Country:

China 

Province:

Sichuan 

City:

Nanchong 

单位(医院):

川北医学院 

单位级别:

大学 

Institution
hospital:

North Sichuan Medical College  

Level of the institution:

college 

测量指标:

Outcomes:

指标中文名:

体质量指数

指标类型:

主要指标 

Outcome:

BMI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基础代谢率

指标类型:

主要指标 

Outcome:

BMR

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 rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

注意力指数

指标类型:

主要指标 

Outcome:

Attention 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:

放松度指数

指标类型:

主要指标 

Outcome:

Relaxaion 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:

Stroop反应时间

指标类型:

主要指标 

Outcome:

Reaction time of Stroop

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Stroop正确率

指标类型:

主要指标 

Outcome:

Accuracy of Stroop

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动自觉量表评分

指标类型:

主要指标 

Outcome:

Rate of perceived exertion (RPE)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动愉悦感

指标类型:

次要指标 

Outcome:

Rate of joy

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

时间流逝感

指标类型:

次要指标 

Outcome:

Rate of time passing

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

选择倾向性

指标类型:

次要指标 

Outcome:

Rate of tendency

Type:

Secondary 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:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 19 years
最大 Max age 25 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):

本实验主要采用自身前后对照研究

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

No

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

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):

2020.12.31; ResMan (www.medresman.org)

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

2020.12.31; ResMan (www.medresman.org)

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:

ResMan-www.medresman.org(所有受试者均为健康人,故不涉及病历)

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

ResMan-www.medresman.org (All of subjects are healthy without medical history.)

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-09-15
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