今天是:2020-07-07 星期二

肺康复对新型冠状病毒肺炎(COVID-19)患者康复期肺功能及生存质量的影响
下载XML文档

注册号:

Registration number:

ChiCTR2000029459 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

肺康复对新型冠状病毒肺炎(COVID-19)患者康复期肺功能及生存质量的影响 

Public title:

The effect of pulmonary rehabilitation for pulmonary function and quality of life in patients with novel coronavirus pneumonia (COVID-19) in rehabilitation period 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肺康复对新型冠状病毒肺炎(COVID-19)患者康复期肺功能及生存质量的影响 

Scientific title:

Pulmonary rehabilitation to improve pulmonary function and quality of life in patients with novel coronavirus pneumonia (COVID-19) in rehabilitation period 

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:

李正良 

研究负责人:

夏文广 

Applicant:

Zhengliang Li 

Study leader:

Wenguang Xia 

申请注册联系人电话:

Applicant telephone:

+86 17771435723 

研究负责人电话:

Study leader's telephone:

+86 13377897278 

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:

lizhengliang23@163.com 

研究负责人电子邮件:

Study leader's E-mail:

docxwg@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:

湖北省武汉市江汉区菱角湖路11号 

研究负责人通讯地址:

湖北省武汉市江汉区菱角湖路11号 

Applicant address:

11 Lingjiao Lake Road, Jianghan District, Wuhan, Hubei, China 

Study leader's address:

11 Lingjiao Lake Road, Jianghan District, Wuhan, Hubei, China  

申请注册联系人邮政编码:

Applicant postcode:

430000 

研究负责人邮政编码:

Study leader's postcode:

430000 

申请人所在单位:

1.湖北中医药大学附属新华医院2.湖北省中西医结合医院 

Applicant's institution:

1.Xinhua affiliated hospital, Hubei University of Chinese Medicine; 2. Hubei Provincial Hospital of Integrated Chinese and Western Medicine 

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:

2020007 

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:

湖北省中西医结合医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Hubei Provincial Hospital of Integrated Chinese and Western Medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-01 

伦理委员会联系人:

夏文广 

Contact Name of the ethic committee:

Wenguang Xia 

伦理委员会联系地址:

湖北省武汉市江汉区菱角湖路11号 

Contact Address of the ethic committee:

11 Lingjiao Lake Road, Jianghan District, Wuhan, Hubei, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 027-65600806 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

docxwg@163.com 

研究实施负责(组长)单位:

1.湖北中医药大学附属新华医院2.湖北省中西医结合医院 

Primary sponsor:

1.Xinhua affiliated hospital, Hubei University of Chinese Medicine; 2. Hubei Provincial Hospital of Integrated Chinese and Western Medicine 

研究实施负责(组长)单位地址:

湖北省武汉市江汉区菱角湖路11号 

Primary sponsor's address:

11 Lingjiao Lake Road, Jianghan District, Wuhan, Hubei, 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):

湖北

市(区县):

武汉市

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

1.湖北中医药大学附属新华医院2.湖北省中西医结合医院

具体地址:

湖北省武汉市江汉区菱角湖路11号

Institution
hospital:

1.Xinhua affiliated hospital, Hubei University of Chinese Medicine; 2. Hubei Provincial Hospital of Integrated Chinese and Western Medicine

Address:

11 Lingjiao Lake Road, Jianghan District, Wuhan, Hubei, China

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

new coronavirus pneumonia (COVID-19) 

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:

探究肺康复对新型冠状病毒感染的肺炎患者康复期肺功能及生存质量的影响 

Objectives of Study:

To explore the effect of Pulmonary rehabilitation to improve pulmonary function and quality of life in Patients with 2019-nCoV pneumonia (common type, rehabilitation period)  

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符合新型冠状病毒感染的肺炎的确诊病例; ②经过治疗后病毒核酸已转阴; ③年龄在18~70岁之间; ④意识清楚; ⑤知情同意并签署并自愿签订《知情同意书》。 

Inclusion criteria

1. patients diagnosed as Pneumonia caused by new coronavirus infection (2019-nCoV); 2. virus turned negative after treatment; 3. aged 18-70 years old; 4. patients with clear consciousness; 5. Signing the informed consent form. 

排除标准:

①合并严重的肝、肾、血液病变以及内分泌系统原发病者; ②孕妇或哺乳期妇女; ③患者有精神异常、有药物滥用或依赖史、对研究用药过敏、3个月内参加过其他临床研究等。  

Exclusion criteria:

1. Patients with serious illnesses, such as heart, liver, kidney, endocrine diseases and hematopoietic system disease; 2. Pregnant or lactating women; 3. Patients with mental confusion, with a history of drug abuse or dependence, who allergic to study medication, who have participated in another clinical trial within 3 months,or who have other conditions not suitable for clinical study. 

研究实施时间:

Study execute time:

From2020-02-03To 2021-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

50

Group:

experimental group

Sample size:

干预措施:

肺康复+常规治疗

干预措施代码:

Intervention:

Pulmonary rehabilitation+Conventional treatment

Intervention code:

组别:

对照组

样本量:

50

Group:

control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Conventional treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

1.湖北中医药大学附属新华医院2.湖北省中西医结合医院 

单位级别:

三甲医院 

Institution
hospital:

1.Xinhua affiliated hospital,Hubei University of Chinese Medicine 2.Hubei Provincial Hospital of Integrated Chinese and Western Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

肺功能

指标类型:

主要指标 

Outcome:

pulmonary function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

圣乔治呼吸问卷

指标类型:

主要指标 

Outcome:

St Georges respiratory questionnaire, SGRQ

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

日常生活活动能力评定

指标类型:

次要指标 

Outcome:

Modified Barthel Index, MBI

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件发生率

指标类型:

次要指标 

Outcome:

Incidence of adverse events

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

6 min步行试验

指标类型:

次要指标 

Outcome:

6-minute walk test, 6MWT

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 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):

负责随机的研究人员采用spss产生随机序列

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

SPSS was used to generate random sequences

盲法:

未说明

Blinding:

Not stated

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):

期刊论文和会议论文

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

journal article and conference paper

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:

通过病例记录表采集记录数据,建立电子数据库管理数据

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

Collect record data through case record table and establish electronic database management data

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-02
返回列表