今天是:2019-06-18 星期二

肺康复对缓解期慢性阻塞性肺病患者生活质量改善的研究
下载XML文档

注册号:

Registration number:

ChiCTR1900023807 

最近更新日期:

Date of Last Refreshed on:

2019-06-12 

注册时间:

Date of Registration:

2019-06-12 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

肺康复对缓解期慢性阻塞性肺病患者生活质量改善的研究 

Public title:

Improvement of quality of life in patients with chronic obstructive pulmonary disease in remission stage by lung rehabilitation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肺康复对缓解期慢性阻塞性肺病患者生活质量改善的研究 

Scientific title:

Improvement of quality of life in patients with chronic obstructive pulmonary disease in remission stage by lung rehabilitation 

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:

张蕊 

研究负责人:

张蕊 

Applicant:

Zhang Rui 

Study leader:

Zhang Rui 

申请注册联系人电话:

Applicant telephone:

+86 13811929366 

研究负责人电话:

Study leader's telephone:

+86 13811929366 

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:

zhangrui2779@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangrui2779@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:

北京市昌平区鼓楼北街9号 

研究负责人通讯地址:

北京市昌平区鼓楼北街9号 

Applicant address:

9 Gulou Street North, Changping, Beijing, China 

Study leader's address:

9 Gulou Street North, Changping, Beijing, 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:

北京市昌平区医院 

Applicant's institution:

Beijing Changping District Hospital 

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:

京昌平卫伦理备字(2019)001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:

昌平区医院伦理委员会 

Name of the ethic committee:

Changping Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

张彦虎 

Contact Name of the ethic committee:

Zhang Yanhu 

伦理委员会联系地址:

北京市昌平区鼓楼北街9号 

Contact Address of the ethic committee:

9 Gulou Street North, Changping, Beijing, 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:

北京市昌平区医院 

Primary sponsor:

Beijing Changping District Hospital 

研究实施负责(组长)单位地址:

北京市昌平区鼓楼北街9号 

Primary sponsor's address:

9 Gulou Street North, Changping, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京市昌平区医院

具体地址:

北京市昌平区鼓楼北街9号

Institution
hospital:

Beijing Changping District Hospital

Address:

9 Gulou Street North, Changping, Beijing, China

经费或物资来源:

区科研专项经费(资助) 

Source(s) of funding:

Special Funds for Regional Scientific Research (Subsidies) 

研究疾病:

慢性阻塞性肺疾病 

Target disease:

Chronic obstructive pulmonary disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

慢性阻塞性肺疾病是一种常见、多发、高致残率和高病死率的慢性呼吸道疾病,严重影响了患者的生活质量。通过全面准确的进行病情评估,制定个体化性肺康复计划,使患者达到稳定或逆转疾病的全身表现,减少急性发作次数,减少住院次数,提高生活质量,回归家庭回归社会,从而达到肺康复的目的。 

Objectives of Study:

Chronic obstructive pulmonary disease (COPD) is a common, multiple, high disability and mortality chronic respiratory disease, which seriously affects the quality of life of patients. Through a comprehensive and accurate assessment of the condition, individualized lung rehabilitation plan is formulated to stabilize or reverse the overall performance of the disease, reduce the number of acute attacks, reduce the number of hospitalizations, improve the quality of life, return to the family and society, so as to achieve the goal of lung rehabilitation. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

诊断符合我国《慢性阻塞性肺疾病防治指南》制定的诊断标准。稳定期慢阻肺患者。 

Inclusion criteria

The diagnosis conforms to the diagnostic criteria established in the Guidelines for the Prevention and Treatment of Chronic Obstructive Pulmonary Disease (COPD). Stable COPD patients. 

排除标准:

非稳定期慢阻肺患者 

Exclusion criteria:

Chronic obstructive pulmonary disease in unstable phase 

研究实施时间:

Study execute time:

From2018-02-01To 2019-10-01 

干预措施:

Interventions:

组别:

肺康复训练组

样本量:

100

Group:

Experimental group

Sample size:

干预措施:

呼吸功能锻炼,肢体运动锻炼

干预措施代码:

Intervention:

Routine management plus respiratory function exercise, limb exercise

Intervention code:

组别:

对照组

样本量:

100

Group:

Control group

Sample size:

干预措施:

常规药物治疗,每2周进行饮食指导、规范用氧、戒烟等常规内容的电话随访

干预措施代码:

Intervention:

Routine management

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市昌平区医院 

单位级别:

三级 

Institution
hospital:

Beijing Changping District Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

圣乔治生活质量评分

指标类型:

主要指标 

Outcome:

St. George's Quality of Life Score

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:

组织:

Sample Name:

nothing

Tissue:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 42 years
最大 Max age 80 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):

非随机分组

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

N/A

盲法:

N/A

Blinding:

N/A

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):

ResMan临床试验公共管理平台

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

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:

病例记录表 ResMan

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

CRF ResMan

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-06-12
返回列表