ChiCTR1800015213 版本V1.0 版本创建时间2018/03/15 21:12:26 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR1800015213 

最近更新日期：

Date of Last Refreshed on：

 2018-03-15 21:12:13 

注册时间：

Date of Registration：

 2018-03-15 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

運動介入計畫對血液透析病人身體功能相關變項之成效

Public title：

Three-month intradialytic cycling exercise improves physical functional performance and strengthens muscle in haemodialysis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

運動介入計畫對血液透析病人身體功能相關變項之成效

Scientific title：

Three-month intradialytic cycling exercise improves physical functional performance and strengthens muscle in haemodialysis

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：

劉月敏 

研究负责人：

葉美玲 

Applicant：

Yueh-Min Liu 

Study leader：

Mei-Ling Yeh 

申请注册联系人电话：

Applicant telephone：

 +886 2 24372093

研究负责人电话：

Study leader's
telephone：

+886 2 28227101

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：

 minmin19680921@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 meiling@ntunhs.edu.tw

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：

中國臺灣基隆中山區復興路336號

研究负责人通讯地址：

中國臺灣省臺北市明德路365號

Applicant address：

336 Fuxing Road, Zhongshan District, Keelung, Taiwan, China

Study leader's address：

365 Minte Road, Taipei, Taiwan, 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：

經國管理暨健康學院

Applicant's institution：

Ching Kuo Institute of Management and Health

研究负责人所在单位：

經國管理暨健康學院

Affiliation of the Leader：

Ching Kuo Institute of Management and Health

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：

 CTH-102-3-5-002

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：

天主教耕莘醫療財團法人耕莘醫院

Name of the ethic committee：

Cardinal Tien Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 1990-01-01 00:00:00

伦理委员会联系人：

Ting-Ywan Chou

Contact Name of the ethic committee：

Ting-Ywan Chou

伦理委员会联系地址：

中國臺灣新臺北市新店區中正路362號

Contact Address of the ethic committee：

362, Zhongzheng Road, Xindian District, New Taipei City 23155, Taiwan, 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：

血液透析中心

Primary sponsor：

Hemodialysis center

研究实施负责（组长）单位地址：

中國臺灣新臺北市新店區中正路362號

Primary sponsor's address：

362 Zhongzheng Road, Xindian District, New Taipei City 23155, Taiwan, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

臺灣

市(区县)：

Country：

China

Province：

Taiwan

City：

New Taipei

单位(医院)：

天主教耕莘醫療財團法人耕莘醫院

具体地址：

中國臺灣新臺北市新店區中正路362號

Institution
hospital：

Cardinal Tien Hospital

Address：

362 Zhongzheng Road, Xindian District, New Taipei City 23155, Taiwan, China

经费或物资来源：

天主教耕莘醫療財團法人耕莘醫院

Source(s) of funding：

Cardinal Tien Hospital

研究疾病：

終末期腎病  

Target disease：

End stage of renal 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：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

運動介入計畫對血液透析病人身體功能相關變項  

Objectives of Study：

This study aimed to evaluate the effects of intra-dialytic aerobic and resistance cycling exercise program (ARCEP) on physical function, depression, fatigue, and HRQoL in HD patients, and further confirmed the mediator effects of exercise self-efficacy and resilience in the exercise group.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

(1) age above 20 years old and consented to join the study;
(2) receive HD 3 times a week at least 3 months;
(3) not miss more than two dialysis sessions in the prior month;
(4) Kt/V (dialysis efficacy) ≧1.2 and stable on HD;
(5) ambulatory with or without using the assistance device, can walk for at least 50 meters;
(6) have arteriovenous grafts or native fistulas; and
(7) basic comprehension and communication in Chinese or Taiwanese.

Inclusion criteria

(1) age above 20 years old and consented to join the study;
(2) receive HD 3 times a week at least 3 months;
(3) not miss more than two dialysis sessions in the prior month;
(4) Kt/V (dialysis efficacy) ≧1.2 and stable on HD;
(5) ambulatory with or without using the assistance device, can walk for at least 50 meters;
(6) have arteriovenous grafts or native fistulas; and
(7) basic comprehension and communication in Chinese or Taiwanese.

排除标准：

(1) active infection or inflammation;
(2) autoimmunity disorders;
(3) cerebrovascular accidents within prior 6 months;
(4) presence of severe muscle weakness or interfering skeletal deformity;
(5) history of repeated episodes of hypoglycemia;
(6) cardiopulmonary contraindications to resistance exercise such as myocardial infarction within prior 6 months, unstable angina, and uncompensated congestive heart failure;
(7) lower limb amputation; and
(8) history of prior regular exercise program.

Exclusion criteria：

(1) active infection or inflammation;
(2) autoimmunity disorders;
(3) cerebrovascular accidents within prior 6 months;
(4) presence of severe muscle weakness or interfering skeletal deformity;
(5) history of repeated episodes of hypoglycemia;
(6) cardiopulmonary contraindications to resistance exercise such as myocardial infarction within prior 6 months, unstable angina, and uncompensated congestive heart failure;
(7) lower limb amputation; and
(8) history of prior regular exercise program.

研究实施时间：

Study execute time：

从 From 2012-09-01 00:00:00至 To 2014-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2013-06-01 00:00:00 至 To 2014-08-31 00:00:00

干预措施：

Interventions：

组别：

exercise group

样本量：

 38

Group：

exercise group

Sample size：

干预措施：

Three-month intradialytic cycling exercise

干预措施代码：

Intervention：

Three-month intradialytic cycling exercise

Intervention code：

组别：

control group

样本量：

 38

Group：

control group

Sample size：

干预措施：

exercise

干预措施代码：

Intervention：

exercise

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 臺灣 

市(区县)：

  

Country：

China

Province：

Taiwan

City：

New Taipei

单位(医院)：

 天主教耕莘醫療財團法人耕莘醫院 

单位级别：

 Regional hospital 

Institution
hospital：

cardinal Tien Hospital

Level of the institution：

Regional hospital

测量指标：

Outcomes：

指标中文名：

To determine the effects of exercise program during HD on the primary outcomes of physical function, depression, fatigue, and HRQoL in HD patients

指标类型：

主要指标

Outcome：

To determine the effects of exercise program during HD on the primary outcomes of physical function, depression, fatigue, and HRQoL in HD patients

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：

No

组织：

Sample Name：

No

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 24 岁 years
最大 Max age 79 岁 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）：

This was randomized controlled trial. The procedure of randomization was done by using a computer generated random numbers. One of the Ph.D student (Wang) generated the random number sequence and she was not involved in the study.

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

This was randomized controlled trial. The procedure of randomization was done by using a computer generated random numbers. One of the Ph.D student (Wang) generated the random number sequence and she was not involved in the study.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

是Yes

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. web-based public database

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

2020. web-based public database

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：

Electronic Data.

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

All participants who met the inclusion criteria were assigned into two groups. The control group received nursing routine care. The exercise group received not only nursing routine care but the 3-month exercise program. Data were repeatedly collected at baseline, Mon 1, Mon 2, and Mon 3. At the end of each monthly exercise routine, the control and exercise group underwent physical function measurements, which involved 6MWT, STS-10, and STS-60. Totally, four measurement periods were conducted. Data were collected over a 14 months from June, 2013 to August, 2014.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2018-03-15 21:12:13