今天是:2019-06-17 星期一

养肺运动处方对COPD患者的康复效果
下载XML文档

注册号:

Registration number:

ChiCTR1800017405 

最近更新日期:

Date of Last Refreshed on:

2018-07-28 

注册时间:

Date of Registration:

2018-07-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

养肺运动处方对COPD患者的康复效果 

Public title:

Effects of pulmonary rehabilitation prescription on COPD patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

养肺运动处方对COPD患者的康复效果 

Scientific title:

Effects of pulmonary rehabilitation prescription on COPD patients 

研究课题代号(代码):

Study subject ID:

中国国家体育总局国家健身项目(2017B021),上海市科学技术委员会定向研究经费(18DZ1200600) 

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:

李培君 

研究负责人:

刘晓丹 

Applicant:

Peijun Li 

Study leader:

Xiaodan Liu 

申请注册联系人电话:

Applicant telephone:

+86 18901997471 

研究负责人电话:

Study leader's telephone:

+86 15800668700 

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:

lpj0227@163.com 

研究负责人电子邮件:

Study leader's E-mail:

hzhp403@126.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:

中国上海市杨浦区恒仁路188号 

研究负责人通讯地址:

中国上海市浦东新区蔡伦路300号 

Applicant address:

188 Hengren Road, Yangpu District, Shanghai, China 

Study leader's address:

300 Cailun Road, Pudong New Distinct, 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:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

上海中医药大学 

Primary sponsor:

Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市浦东新区蔡伦路300号 

Primary sponsor's address:

300 Cailun Road, Pudong New Distinct, 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):

上海中医药大学附属岳阳中西医结合医院

具体地址:

上海市虹口区甘河路110号

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine

Address:

110 Ganhe Road, Hongkou District, Shanghai

经费或物资来源:

中国国家体育总局国家健身项目(2017B021),上海市科学技术委员会定向研究经费(18DZ1200600) 

Source(s) of funding:

the national fitness project of General Administration of Sport of China (No. 2017B021), the directed research grants from Science and Technology Commission of Shanghai Municipality (No. 18DZ1200600) 

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:

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:

本研究的主要目的是评价“慢性阻塞性肺疾病养肺运动处方”对COPD患者综合病情的干预效果,并通过对比不同运动干预方法对COPD的作用,明确养肺运动处方在干预COPD病情方面的作用角色。为COPD患者提供简单易学、可操作、富于乐趣的干预方法,以延缓COPD病情进展。 

Objectives of Study:

The main purpose of this study was to evaluate the effect of "pulmonary rehabilitation prescription" on COPD patients. The secondary objective was to determine the role of pulmonary rehabilitation prescription in the intervention of COPD by comparing the effects of different exercise intervention methods on COPD. To provide a simple, easy-to-learn, operable and fun intervention for COPD patients to delay the progression of the disease. 

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2018版GOLD诊断标准的COPD患者; (2)参与试验前4周处于稳定期; (3)性别不限,年龄40-80岁; (4)自愿参加; (5)参与试验前至少6个月没有规律运动(每周≥2次的运动认为是规律运动)。 

Inclusion criteria

(1) diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (2018); (2) clinically stable in the past 4 weeks; (3) of either sex and between the age of 40–80 years; (4) volunteer to participate; (5) and have not exercised regularly for at least 6 months before the study (at least twice a week).  

排除标准:

(1)处于COPD急性加重期; (2)存在影响运动表现的并发症; (3)有运动限制的心血管或神经肌肉系统疾病; (4)有肢体肌力训练的禁忌症; (5)有肌电测试的禁忌症。 

Exclusion criteria:

(1) presented with an exacerbation of the disease; (2) with physical comorbidities that prevented them from performing exercise; (3) with exercise-limiting cardiovascular or neuromuscular diseases; (4) not suitable for an assessment of muscle strength of the limbs; (5) with contraindications to electromyography tests. 

研究实施时间:

Study execute time:

From2018-03-16To 2019-11-30 

干预措施:

Interventions:

组别:

对照组

样本量:

20

Group:

1

Sample size:

干预措施:

常规西药治疗

干预措施代码:

Intervention:

Conventional treatment

Intervention code:

组别:

步行锻炼组

样本量:

20

Group:

2

Sample size:

干预措施:

常规西医治疗+每天2次20-30min步行锻炼,每周5天

干预措施代码:

Intervention:

Conventional treatment + walking

Intervention code:

组别:

养肺运动处方组

样本量:

20

Group:

3

Sample size:

干预措施:

常规西医治疗+每天2次30-40min养肺运动处方,每周5天

干预措施代码:

Intervention:

Conventional treatment + pulmonary rehabilitation prescription

Intervention code:

组别:

抗阻运动组

样本量:

20

Group:

4

Sample size:

干预措施:

常规西医治疗+每天2次30-40min上下肢抗阻运动,每周5天

干预措施代码:

Intervention:

Conventional treatment + Upper and lower extremities resistance movement

Intervention code:

组别:

养肺运动处方联合抗阻运动组

样本量:

20

Group:

5

Sample size:

干预措施:

常规西医治疗+养肺运动处方+抗阻运动

干预措施代码:

Intervention:

Conventional treatment + Upper and lower extremities resistance movement + pulmonary rehabilitation prescription

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):

上海中医药大学附属岳阳中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

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:

省部共建高校 

Institution
hospital:

Shanghai University of Sport  

Level of the institution:

University 

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:

呼吸肌肌力

指标类型:

主要指标 

Outcome:

respiratory muscle strength

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动能力

指标类型:

主要指标 

Outcome:

exercise capacity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

表面肌电

指标类型:

次要指标 

Outcome:

Surface electromyography

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量

指标类型:

次要指标 

Outcome:

quality of life

Type:

Secondary indicator 

测量时间点:

测量方法:

SGRQ

Measure time point of outcome:

Measure method:

指标中文名:

呼吸困难

指标类型:

次要指标 

Outcome:

dyspnea

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心理功能

指标类型:

次要指标 

Outcome:

psychological function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身体成分

指标类型:

次要指标 

Outcome:

body composition

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体力活动水平

指标类型:

次要指标 

Outcome:

physical activity level

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

自我效能

指标类型:

次要指标 

Outcome:

General Self-Efficacy Scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

认知功能

指标类型:

次要指标 

Outcome:

cognitive function

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 40 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):

由不直接参与纳入受试者的工作人员,采用简单随机分组方法产生随机序列,装入不透光的密封信封。

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

A random sequence was generated by a simple random grouping method by a staff member who was not directly involved in the inclusion of the objects, and was filled with an opaque sealed envelope.

盲法:

N/A

Blinding:

N/A

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):

网络平台 网址:www.chictr.org.cn/

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

Network platform web site: www.chictr.org.cn/

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:

数据包括原始记录、病例记录表等数据,采用spss数据库。

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

Data include the original records, case records and other data, using the SPSS database.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-07-28
返回列表