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隨機對照研究調查產前運動教育干預對改善懷孕婦女腰背痛之效果
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注册号：

Registration number：

 ChiCTR-INR-17011308 

最近更新日期：

Date of Last Refreshed on：

 2017-05-05 13:31:40 

注册时间：

Date of Registration：

 2017-05-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

隨機對照研究調查產前運動教育干預對改善懷孕婦女腰背痛之效果

Public title：

A randomized controlled trial to evaluate the effectiveness of an ehealth antenatal exercise intervention in improving lumbopelvic pain in Hong Kong chinese pregnant women

注册题目简写：

English Acronym：

研究课题的正式科学名称：

隨機對照研究調查產前運動教育干預對改善懷孕婦女腰背痛之效果

Scientific title：

A randomized controlled trial to evaluate the effectiveness of an ehealth antenatal exercise intervention in improving lumbopelvic pain in Hong Kong chinese pregnant women

研究课题代号(代码)：

Study subject ID：

 CREC IRB no.: 2017.139-T

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：

CUHK_CCRB00555

申请注册联系人：

Au Yeung Elce 

研究负责人：

Au Yeung Elce 

Applicant：

Au Yeung Elce 

Study leader：

Au Yeung Elce 

申请注册联系人电话：

Applicant telephone：

 +852 35053713

研究负责人电话：

Study leader's
telephone：

+852 35053713

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：

 ae483@ha.org.hk

研究负责人电子邮件：

Study leader's E-mail：

 ae483@ha.org.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/445

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/445

申请注册联系人通讯地址：

School of Midwifery, Prince of Wales Hospital, Shatin, Hong Kong

研究负责人通讯地址：

School of Midwifery, Prince of Wales Hospital, Shatin, Hong Kong

Applicant address：

School of Midwifery, Prince of Wales Hospital, Shatin, Hong Kong

Study leader's address：

School of Midwifery, Prince of Wales Hospital, Shatin, Hong Kong

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：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

Affiliation of the Leader：

The Chinese University of Hong Kong

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：

 2017.139_T

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：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2017-03-29 00:00:00

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：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

School of Midwifery, Prince of Wales Hospital, Shatin, Hong Kong

Primary sponsor's address：

School of Midwifery, Prince of Wales Hospital, Shatin, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Not Applicable

Source(s) of funding：

Not Applicable

研究疾病：

懷孕婦女腰背痛  

Target disease：

lumbopelvic pain

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：

調查產前運動教育干預對改善懷孕婦女腰背痛之效果  

Objectives of Study：

To evaluate the effectiveness of an ehealth antenatal exercise intervention in improving lumbopelvic pain in Hong Kong chinese pregnant women

药物成份或治疗方案详述：

The intervention include: smartphone apps, information booklet, counseling, telephone boosters at 4th and 8th week of recruitment. Counseling at recruitment, information booklet and apps provide readily available information; Aiming at achieving 150 minutes of antenatal exercise per week, total 12 weeks. Usual antenatal care (control): information leaflet and counseiling; telephone booster at 4th and 8th weeks of recruitment, once in 12 weeks. 

Description for medicine or protocol of treatment in detail：

The intervention include: smartphone apps, information booklet, counseling, telephone boosters at 4th and 8th week of recruitment. Counseling at recruitment, information booklet and apps provide readily available information; Aiming at achieving 150 minutes of antenatal exercise per week, total 12 weeks. Usual antenatal care (control): information leaflet and counseiling; telephone booster at 4th and 8th weeks of recruitment, once in 12 weeks. 

纳入标准：

Inclusion criteria

排除标准：

1. contraindication against performing antenatal exercise as listed by the American College of Obstetricians and Gynecologist (2015);
2. any current or past history of psychiatric disease;
3. refusal to participate in the study.

Exclusion criteria：

1. contraindication against performing antenatal exercise as listed by the American College of Obstetricians and Gynecologist (2015);
2. any current or past history of psychiatric disease;
3. refusal to participate in the study.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-05-15 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 134

Group：

Two groups

Sample size：

干预措施：

usual antenatal care and antenatal exercise intervention versus Usual antenatal care

干预措施代码：

Intervention：

usual antenatal care and antenatal exercise intervention versus Usual antenatal care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 The Chinese University of Hong Kong 

单位级别：

 The Chinese University of Hong Kong 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

The Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

the prevalence of LPP

指标类型：

主要指标

Outcome：

the prevalence of LPP

Type：

Primary indicator

测量时间点：

at recruitment and 12th week

测量方法：

A numeric pain rating scale (NPRS)

Measure time point of outcome：

at recruitment and 12th week

Measure method：

A numeric pain rating scale (NPRS)

指标中文名：

functional disability of LPP

指标类型：

主要指标

Outcome：

functional disability of LPP

Type：

Primary indicator

测量时间点：

at recruitment and 12th week

测量方法：

Hong Kong version of Roland Morris Disability Questionnaire

Measure time point of outcome：

at recruitment and 12th week

Measure method：

Hong Kong version of Roland Morris Disability Questionnaire

指标中文名：

physical activity level

指标类型：

次要指标

Outcome：

physical activity level

Type：

Secondary indicator

测量时间点：

at recruitment and 12th week

测量方法：

Chinese version of Pregnancy Physical Activity Questionnaire

Measure time point of outcome：

at recruitment and 12th week

Measure method：

Chinese version of Pregnancy Physical Activity Questionnaire

指标中文名：

risk of antenatal depression

指标类型：

次要指标

Outcome：

risk of antenatal depression

Type：

Secondary indicator

测量时间点：

at recruitment and 12th week

测量方法：

Chinese version of Edinburgh Postnatal Depression Scale (EPDS)

Measure time point of outcome：

at recruitment and 12th week

Measure method：

Chinese version of Edinburgh Postnatal Depression Scale (EPDS)

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 岁 years
最大 Max age 45 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

Block randomization

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

Block randomization

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Single-blind Trial subjects

Blinding：

Single-blind Trial subjects

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

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）：

Not stated

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

Not stated

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：

Not stated

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2017-05-05 13:31:41
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