ChiCTR1900025397 版本V1.0 版本创建时间2019/08/26 03:46:16 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：

 ChiCTR1900025397 

最近更新日期：

Date of Last Refreshed on：

 2019-08-26 03:46:01 

注册时间：

Date of Registration：

 2019-08-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effects of mindfulness of sound for Parkinson's disease

Public title：

Effects of mindfulness of sound for Parkinson's disease

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A randomized trial on the comparative effects of ‘mindfulness of sound’ versus stretching and resistance training exercises on physio-psycho-spiritual wellbeing in people with Parkinson’s disease

Scientific title：

A randomized trial on the comparative effects of ‘mindfulness of sound’ versus stretching and resistance training exercises on physio-psycho-spiritual wellbeing in people with Parkinson’s disease

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：

Leo Lam Chun Chung 

研究负责人：

Dr Jojo Kwok Yan Yan 

Applicant：

Leo Lam Chun Chung 

Study leader：

Dr Jojo Kwok Yan Yan 

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

研究负责人通讯地址：

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

Applicant address：

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

Study leader's address：

School of Nursing, 4/F William MW Mong Block, 21 Sassoon Road, Pokfulam, 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：

香港中文大學

Applicant's institution：

The University of Hong Kong

研究负责人所在单位：

香港中文大學

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：

 UW 19-446

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：

 2019-07-25 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：

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

Contact Address of the ethic committee：

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

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：

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：

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：

随机抽样 

Study design：

Randomly Sampling 

研究目的：

To examine the comparative effects of mindfulness of sound on psychological distress, motor symptoms, non-motor symptoms, mobility and gait, mindfulness attitude, and HRQOL of PD individuals, compared with stretching and resistant training exercises.  

Objectives of Study：

To examine the comparative effects of mindfulness of sound on psychological distress, motor symptoms, non-motor symptoms, mobility and gait, mindfulness attitude, and HRQOL of PD individuals, compared with stretching and resistant training exercises.

药物成份或治疗方案详述：

Participants from the mindfulness of sound will receive eight weekly 90-min sound meditation. Participants from the stretching and resistant training exercises group will receive eight weekly 90-min stretching and resistant training exercises during the study period. 

Description for medicine or protocol of treatment in detail：

Participants from the mindfulness of sound will receive eight weekly 90-min sound meditation. Participants from the stretching and resistant training exercises group will receive eight weekly 90-min stretching and resistant training exercises during the study period. 

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 stand unaided and walk with or without an assistive device, and
4. able to give written consent.

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 stand unaided and walk with or without an assistive device, and
4. able to give written consent.

排除标准：

Individuals will be excluded if they:
1. have been regularly practicing instructor-led mind-body interventions such as meditation, yoga, Tai Chi, Qigong, or dance 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, or
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：

Individuals will be excluded if they:
1. have been regularly practicing instructor-led mind-body interventions such as meditation, yoga, Tai Chi, Qigong, or dance 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, or
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 2019-08-26 00:00:00至 To 2021-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-08-26 00:00:00 至 To 2019-12-31 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：

Sound Meditation

干预措施代码：

Intervention：

Sound Meditation

Intervention code：

组别：

Control group

样本量：

 56

Group：

Control group

Sample size：

干预措施：

Stretching and resistance exercise

干预措施代码：

Intervention：

Stretching and resistance exercise

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)：

 Queen Mary Hospital 

单位级别：

 Queen Mary Hospital 

Institution
hospital：

Queen Mary Hospital

Level of the institution：

Queen Mary Hospital

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)：

 Tung Wah Hospital 

单位级别：

 Tung Wah Hospital 

Institution
hospital：

Tung Wah Hospital

Level of the institution：

Tung Wah Hospital

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 Society for Rehabilitation 

单位级别：

 Hong Kong Society for Rehabilitation 

Institution
hospital：

Hong Kong Society for Rehabilitation

Level of the institution：

Hong Kong Society for Rehabilitation

测量指标：

Outcomes：

指标中文名：

Psychological distress

指标类型：

主要指标

Outcome：

Psychological distress

Type：

Primary indicator

测量时间点：

(i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention

测量方法：

Hospital Anxiety and Depression Scale

Measure time point of outcome：

(i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention

Measure method：

Hospital Anxiety and Depression Scale

指标中文名：

Motor symptoms and non-motor symptoms

指标类型：

次要指标

Outcome：

Motor symptoms and non-motor symptoms

Type：

Secondary indicator

测量时间点：

(i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention

测量方法：

Movement Disorder Society – Unified Parkinson’s Disease Rating Scale

Measure time point of outcome：

(i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention

Measure method：

Movement Disorder Society – Unified Parkinson’s Disease Rating Scale

指标中文名：

Mobility

指标类型：

次要指标

Outcome：

Mobility

Type：

Secondary indicator

测量时间点：

(i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention

测量方法：

Timed-up-and-go test

Measure time point of outcome：

(i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention

Measure method：

Timed-up-and-go test

指标中文名：

Gait analysis

指标类型：

次要指标

Outcome：

Gait analysis

Type：

Secondary indicator

测量时间点：

(i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention

测量方法：

EncephaLog application

Measure time point of outcome：

(i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention

Measure method：

EncephaLog application

指标中文名：

Cognition

指标类型：

次要指标

Outcome：

Cognition

Type：

Secondary indicator

测量时间点：

(i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention

测量方法：

Montreal Cognitive Assessment 5-minute protocol, Hong Kong version

Measure time point of outcome：

(i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention

Measure method：

Montreal Cognitive Assessment 5-minute protocol, Hong Kong version

指标中文名：

Mindfulness attitude

指标类型：

次要指标

Outcome：

Mindfulness attitude

Type：

Secondary indicator

测量时间点：

(i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention

测量方法：

Five-Facet Mindfulness Questionnaire

Measure time point of outcome：

(i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention

Measure method：

Five-Facet Mindfulness Questionnaire

指标中文名：

Health-related quality of life

指标类型：

附加指标

Outcome：

Health-related quality of life

Type：

Additional indicator

测量时间点：

(i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention

测量方法：

Parkinson's Disease Questionnaire-8

Measure time point of outcome：

(i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention

Measure method：

Parkinson's Disease Questionnaire-8

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

No

组织：

Sample Name：

N/A

Tissue：

N/A

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

N/A

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 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）：

A computer-generated randomization sequence will be generated, and the random numbers will be sealed in sequentially numbered, opaque envelopes. After the completion of baseline assessment, participants will be assigned to either one of the two groups following the enclosed assignment in the sealed and opaque envelopes

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

A computer-generated randomization sequence will be generated, and the random numbers will be sealed in sequentially numbered, opaque envelopes. After the completion of baseline assessment, participants will be assigned to either one of the two groups following the enclosed assignment in the sealed and opaque envelopes

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

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：

无/No

注册人：

Name of Registration：

  2019-08-26 03:46:02