ChiCTR2100054145 版本V1.0 版本创建时间2022/11/06 19:25:04 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：

 ChiCTR2100054145 

最近更新日期：

Date of Last Refreshed on：

 2021-12-10 01:17:40 

注册时间：

Date of Registration：

 2021-12-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

A randomised controlled trial on effects of a home-based exercise programme incorporating mindfulness and yoga practice on motor symptoms for people with Parkinson’s Disease

Public title：

A randomised controlled trial on effects of a home-based exercise programme incorporating mindfulness and yoga practice on motor symptoms for people with Parkinson’s Disease

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effects of a Home-based Exercise Programme Incorporating Mindfulness and Yoga Practice on Balance and Mobility for People with Parkinson’s Disease: A Randomised Controlled

Scientific title：

Effects of a Home-based Exercise Programme Incorporating Mindfulness and Yoga Practice on Balance and Mobility for People with Parkinson’s Disease: A Randomised Controlled

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：

Charis Ann Lai 

研究负责人：

Jojo Yan Yan Kwok 

Applicant：

Charis Ann Lai 

Study leader：

Jojo Yan Yan Kwok 

申请注册联系人电话：

Applicant telephone：

 +852-39179861

研究负责人电话：

Study leader's
telephone：

+852-39176644

申请注册联系人传真 ：

Applicant Fax：

 +852-28726079

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：

 charisal@hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 jojoyyk@hku.hk

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：

4/F, William MW Mong Block, 21 Sassoon Road, Pokfulam, Hong Kong, China

研究负责人通讯地址：

4/F, William MW Mong Block, 21 Sassoon Road, Pokfulam, Hong Kong, China

Applicant address：

4/F, William MW Mong Block, 21 Sassoon Road, Pokfulam, Hong Kong, China

Study leader's address：

4/F, William MW Mong Block, 21 Sassoon Road, Pokfulam, Hong Kong, 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：

香港大學

Applicant's institution：

The University of Hong Kong

研究负责人所在单位：

香港大學

Affiliation of the Leader：

The 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：

 UW19-535

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：

Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB)

Name of the ethic committee：

Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB)

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-09-14 00:00:00

伦理委员会联系人：

Mr Chris Yip

Contact Name of the ethic committee：

Mr Chris Yip

伦理委员会联系地址：

Room 901, 9/F, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong, China

Contact Address of the ethic committee：

Room 901, 9/F, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852-22553923

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 hkwirb@ha.org.hk

研究实施负责（组长）单位：

N/A

Primary sponsor：

N/A

研究实施负责（组长）单位地址：

N/A

Primary sponsor's address：

N/A

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong SAR

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

The University of Hong Kong

具体地址：

3 Sassoon Road, Pokfulam, Hong Kong

Institution
hospital：

The University of Hong Kong

Address：

3 Sassoon Road, Pokfulam, Hong Kong

经费或物资来源：

Early Career Scheme, 2021-2022 Research Grants Council

Source(s) of funding：

Early Career Scheme, 2021-2022 Research Grants Council

研究疾病：

Parkinson's disease  

Target disease：

Parkinson's 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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To compare the effects of Mindfulness Yoga-Practice Awareness through Cognitive-based Exercise (MY-PACE) and usual care on perceived freezing of gait (FOG), perceived balance confidence, functional balance, severity of motor symptoms, stress, mindfulness and HRQOL among PD patients.  

Objectives of Study：

To compare the effects of Mindfulness Yoga-Practice Awareness through Cognitive-based Exercise (MY-PACE) and usual care on perceived freezing of gait (FOG), perceived balance confidence, functional balance, severity of motor symptoms, stress, mindfulness and HRQOL among PD patients.

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. diagnosed with idiopathic PD (Hoehn and Yahr stage I-III);
2. aged >=18 years;
3. able to stand unaided and walk with or without an assistive device;
4. have access to the Internet and a smartphone/tablet/laptop;
5. willing to download zoom;
6. able to give written consent.

Inclusion criteria

1. diagnosed with idiopathic PD (Hoehn and Yahr stage I-III);
2. aged >=18 years;
3. able to stand unaided and walk with or without an assistive device;
4. have access to the Internet and a smartphone/tablet/laptop;
5. willing to download zoom;
6. able to give written consent.

排除标准：

1. have been regularly practicing instructor-led mind-body interventions once a week or more during the past 6 months;
2. are currently participating in any other behavioural or pharmacological trial;
3. have cognitive impairment as indicated by the abbreviated mental test lower than 6;
4. have serious medical conditions except PD, or other contraindication to mild-to-moderate physical exertion that might limit their full participation (e.g. severe hearing or vision impairment, significant orthopaedic problems, etc.).

Exclusion criteria：

1. have been regularly practicing instructor-led mind-body interventions once a week or more during the past 6 months;
2. are currently participating in any other behavioural or pharmacological trial;
3. have cognitive impairment as indicated by the abbreviated mental test lower than 6;
4. have serious medical conditions except PD, or other contraindication to mild-to-moderate physical exertion that might limit their full participation (e.g. severe hearing or vision impairment, significant orthopaedic problems, etc.).

研究实施时间：

Study execute time：

从 From 2022-01-01 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-03-01 00:00:00 至 To 2024-01-01 00:00:00

干预措施：

Interventions：

组别：

Group 1

样本量：

 66

Group：

Group 1

Sample size：

干预措施：

Live stream yoga intervention

干预措施代码：

Intervention：

Live stream yoga intervention

Intervention code：

组别：

Group 2

样本量：

 66

Group：

Group 2

Sample size：

干预措施：

Usual care

干预措施代码：

Intervention：

Usual 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 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 香港大学 

单位级别：

  

Institution
hospital：

University of Hong Kong

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Functional Balance

指标类型：

主要指标

Outcome：

Functional Balance

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Freezing of Gait

指标类型：

次要指标

Outcome：

Freezing of Gait

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Functional Mobility

指标类型：

次要指标

Outcome：

Functional Mobility

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Gait patterns with and without obstacle

指标类型：

次要指标

Outcome：

Gait patterns with and without obstacle

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Perceived balance confidence

指标类型：

次要指标

Outcome：

Perceived balance confidence

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

PD-related motor symptoms

指标类型：

次要指标

Outcome：

PD-related motor symptoms

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Anxiety and depressive symptoms

指标类型：

次要指标

Outcome：

Anxiety and depressive symptoms

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Cognitive function and attention

指标类型：

次要指标

Outcome：

Cognitive function and attention

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Mindfulness

指标类型：

次要指标

Outcome：

Mindfulness

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Health-Related Quality of Life, HRQOL

指标类型：

次要指标

Outcome：

Health-Related Quality of Life, HRQOL

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Incidence, reason and consequence of fall

指标类型：

次要指标

Outcome：

Incidence, reason and consequence of fall

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：

标本中文名：

N/A

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

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 100 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）：

All eligible participants will be assigned with a sequential participant number. A computer-generated randomization sequence will be generated, participants will be assigned to either one of the three groups by an independent research assistant.

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

All eligible participants will be assigned with a sequential participant number. A computer-generated randomization sequence will be generated, participants will be assigned to either one of the three groups by an independent research assistant.

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：

All outcome assessors will be blinded to subject allocation.

Blinding：

All outcome assessors will be blinded to subject allocation.

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）：

The data will be available upon request after the study period.

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

The data will be available upon request after the study period.

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：

The study leader will be responsible for using a data management plan (DMP) to describe the use of data, and depositing a dataset in the University of Hong Kong Scholars Hub.

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

The study leader will be responsible for using a data management plan (DMP) to describe the use of data, and depositing a dataset in the University of Hong Kong Scholars Hub.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-12-10 01:17:40