ChiCTR2000033777 版本V1.0 版本创建时间2020/06/14 01:27:19 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：

 ChiCTR2000033777 

最近更新日期：

Date of Last Refreshed on：

 2020-06-12 00:00:07 

注册时间：

Date of Registration：

 2020-06-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effects of a live streaming Mindfulness Yoga - Practice Awareness through Cognitive-based Exercise (MY-PACE) Program on balance and gait for People with Parkinson’s Disease: A Randomised Controlled Trial

Public title：

Effects of a live streaming Mindfulness Yoga - Practice Awareness through Cognitive-based Exercise (MY-PACE) Program for 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 live streaming Mindfulness Yoga - Practice Awareness through Cognitive-based Exercise (MY-PACE) Program on balance and gait for People with Parkinson’s Disease: A Randomised Controlled Trial

Scientific title：

Effects of a live streaming Mindfulness Yoga - Practice Awareness through Cognitive-based Exercise (MY-PACE) Program on balance and gait for People with Parkinson’s Disease: A Randomised Controlled Trial

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：

Lam Chun Chung 

研究负责人：

Dr. Jojo Yan Yan Kwok 

Applicant：

Lam Chun Chung 

Study leader：

Dr. Jojo Yan Yan Kwok 

申请注册联系人电话：

Applicant telephone：

 +852 39176659

研究负责人电话：

Study leader's
telephone：

+852 39176644

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：

 leol@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：

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

研究负责人通讯地址：

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

Applicant address：

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

Study leader's address：

School of Nursing, 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：

香港大學李嘉誠醫學院護理學院

Applicant's institution：

School of Nursing, LKS Faculty of Medicine, Hong Kong

研究负责人所在单位：

香港大學李嘉誠醫學院護理學院

Affiliation of the Leader：

School of Nursing, LKS Faculty of Medicine, 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：

 UW 19-535

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：

 2020-04-20 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：

香港薄扶林道102號瑪麗醫院行政大樓9樓901室

Contact Address of the ethic committee：

Rm 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：

 yipcf@ha.org.hk

研究实施负责（组长）单位：

香港大學李嘉誠醫學院護理學院

Primary sponsor：

School of Nursing, LKS Faculty of Medicine, Hong Kong

研究实施负责（组长）单位地址：

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

Primary sponsor's address：

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

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

University Fund

Source(s) of funding：

University Fund

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 examine the comparative effects between Mindfulness Yoga – Practice Awareness through Cognitive-based Exercise (MY-PACE) and usual care service only for Chinese patients with mild-to-moderate PD, on the following physio-psycho-cognitive outcomes: a)functional mobility (primary outcome), b)perceived balance confidence (primary outcome), c)gait, d)PD-related motor symptoms, e)anxiety and depressive symptoms, f)mindfulness, g)cognitive function, and, h)HRQOL.  

Objectives of Study：

To examine the comparative effects between Mindfulness Yoga – Practice Awareness through Cognitive-based Exercise (MY-PACE) and usual care service only for Chinese patients with mild-to-moderate PD, on the following physio-psycho-cognitive outcomes: a)functional mobility (primary outcome), b)perceived balance confidence (primary outcome), c)gait, d)PD-related motor symptoms, e)anxiety and depressive symptoms, f)mindfulness, g)cognitive function, and, h)HRQOL.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

To be eligible for inclusion, individuals must be
(1) diagnosed with idiopathic PD (Hoehn and Yahr stage I-III);
(2) aged >=18 years;
(3) able to walk with or without an assistive device;
(4) able to give written consent, and
(5) have access to smartphone/ tablet device and Internet connection.

Inclusion criteria

To be eligible for inclusion, individuals must be
(1) diagnosed with idiopathic PD (Hoehn and Yahr stage I-III);
(2) aged >=18 years;
(3) able to walk with or without an assistive device;
(4) able to give written consent, and
(5) have access to smartphone/ tablet device and Internet connection.

排除标准：

Individuals will be excluded if they:
(1) are currently participating in any other behavioural or pharmacological trial;
(2) have significant cognitive impairment as indicated by the Hong Kong Montreal Cognitive Assessment 5-min protocol (HK-MoCA), cutoff scores based on the age and education corrected normative data will be used [11] [12], or
(3) 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：

Individuals will be excluded if they:
(1) are currently participating in any other behavioural or pharmacological trial;
(2) have significant cognitive impairment as indicated by the Hong Kong Montreal Cognitive Assessment 5-min protocol (HK-MoCA), cutoff scores based on the age and education corrected normative data will be used [11] [12], or
(3) 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 2020-06-22 00:00:00至 To 2022-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-06-22 00:00:00 至 To 2022-06-22 00:00:00

干预措施：

Interventions：

组别：

Experimental group

样本量：

 56

Group：

Experimental group

Sample size：

干预措施：

Live streaming Mindfulness Yoga - Practice Awareness through Cognitive-based Exercise (MY-PACE) via Zoom

干预措施代码：

Intervention：

Live streaming Mindfulness Yoga - Practice Awareness through Cognitive-based Exercise (MY-PACE) via Zoom

Intervention code：

组别：

Control group

样本量：

 56

Group：

Control group

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)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Hong Kong Parkinson’s Disease Foundation 

单位级别：

  

Institution
hospital：

Hong Kong Parkinson’s Disease Foundation

Level of the institution：

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)：

 Hong Kong Parkinson’s Disease Association 

单位级别：

  

Institution
hospital：

Hong Kong Parkinson’s Disease Association

Level of the institution：

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)：

 Community Rehabilitation Network 

单位级别：

  

Institution
hospital：

Community Rehabilitation Network

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：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

测量方法：

Berg and Balance Scale (BBS)

Measure time point of outcome：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

Measure method：

Berg and Balance Scale (BBS)

指标中文名：

Perceived balance confidence

指标类型：

主要指标

Outcome：

Perceived balance confidence

Type：

Primary indicator

测量时间点：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

测量方法：

Activities-specific Balance Confidence (ABC) Scale (Chinese version)

Measure time point of outcome：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

Measure method：

Activities-specific Balance Confidence (ABC) Scale (Chinese version)

指标中文名：

Gait

指标类型：

次要指标

Outcome：

Gait

Type：

Secondary indicator

测量时间点：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

测量方法：

Freezing of Gait Questionnaire (Chinese version)

Measure time point of outcome：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

Measure method：

Freezing of Gait Questionnaire (Chinese version)

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：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

测量方法：

Movement Disorder Society-Unified Parkinson’s Disease Rating Scale(MDS-UPDRS)(Chinese version) part III

Measure time point of outcome：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

Measure method：

Movement Disorder Society-Unified Parkinson’s Disease Rating Scale(MDS-UPDRS)(Chinese version) part III

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：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

测量方法：

Hospital Anxiety and Depression Scale (HADS)(Chinese-Cantonese)

Measure time point of outcome：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

Measure method：

Hospital Anxiety and Depression Scale (HADS)(Chinese-Cantonese)

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：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

测量方法：

HK-MoCA-5-min

Measure time point of outcome：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

Measure method：

HK-MoCA-5-min

指标中文名：

Mindfulness

指标类型：

次要指标

Outcome：

Mindfulness

Type：

Secondary indicator

测量时间点：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

测量方法：

Five-Facet Mindfulness Questionnaire (Short-form)(Chinese version)

Measure time point of outcome：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

Measure method：

Five-Facet Mindfulness Questionnaire (Short-form)(Chinese version)

指标中文名：

HRQOL

指标类型：

次要指标

Outcome：

HRQOL

Type：

Secondary indicator

测量时间点：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

测量方法：

Parkinson's Disease Questionnaire-8 (PDQ-8) (Chinese version)

Measure time point of outcome：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

Measure method：

Parkinson's Disease Questionnaire-8 (PDQ-8) (Chinese version)

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：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

测量方法：

Self-reported

Measure time point of outcome：

(i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention

Measure method：

Self-reported

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）：

Eligible participants will be randomly assigned into one of the following conditions on 1:1 basis using a randomization table produced using computer-assisted random number generator.

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

Eligible participants will be randomly assigned into one of the following conditions on 1:1 basis using a randomization table produced using computer-assisted random number generator.

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：

Single-blinded

Blinding：

Single-blinded

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）：

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：

N/A

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

N.A.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2020-06-12 00:00:07