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Combining mind body physical exercise, cognitive training, and nurse-led risk factor modification to enhance cognition among older adults with mild cognitive impairment: a randomized controlled trial
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注册号：

Registration number：

 ChiCTR1900026857 

最近更新日期：

Date of Last Refreshed on：

 2023-11-26 22:53:13 

注册时间：

Date of Registration：

 2019-10-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Combining mind body physical exercise, cognitive training, and nurse-led risk factor modification to enhance cognition among older adults with mild cognitive impairment: a randomized controlled trial

Public title：

Combining mind body physical exercise, cognitive training, and nurse-led risk factor modification to enhance cognition among older adults with mild cognitive impairment: a randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Combining mind body physical exercise, cognitive training, and nurse-led risk factor modification to enhance cognition among older adults with mild cognitive impairment: a randomized controlled trial

Scientific title：

Combining mind body physical exercise, cognitive training, and nurse-led risk factor modification to enhance cognition among older adults with mild cognitive impairment: a randomized controlled trial

研究课题代号(代码)：

Study subject ID：

 Health and Medical Research Fund (16170421)

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：

ZHANG Dexing Daisy 

研究负责人：

Prof. Samuel Yeung Shan WONG  

Applicant：

ZHANG Dexing Daisy 

Study leader：

Prof. Samuel Yeung Shan WONG  

申请注册联系人电话：

Applicant telephone：

 +852 2252 8774

研究负责人电话：

Study leader's
telephone：

+852 2252 8774

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：

 zhangdxdaisy@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 yeungshanwong@cuhk.edu.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：

中國香港沙田香港中文大學醫學院賽馬會公共衞生及基層醫療學院威爾士親王醫院

研究负责人通讯地址：

中國香港沙田香港中文大學醫學院賽馬會公共衞生及基層醫療學院威爾士親王醫院

Applicant address：

4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

Study leader's address：

4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T., 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：

香港中文大學醫學院賽馬會公共衞生及基層醫療學院威爾士親王醫院

Applicant's institution：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學醫學院賽馬會公共衞生及基層醫療學院威爾士親王醫院

Affiliation of the Leader：

JC School of Public Health and Primary Care, 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：

 CREC 2016.342

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC)

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-08-08 00:00:00

伦理委员会联系人：

Ms Envy Lee

Contact Name of the ethic committee：

Ms Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田威爾士親王醫院呂志和臨床科學大樓8/F香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Contact Address of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee 8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2632 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 crec@cuhk.edu.hk

研究实施负责（组长）单位：

香港中文大學醫學院賽馬會公共衞生及基層醫療學院

Primary sponsor：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

香港中文大學醫學院賽馬會公共衞生及基層醫療學院

Primary sponsor's address：

4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T., Hong Kong, 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)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

香港中文大學醫學院賽馬會公共衞生及基層醫療學院

具体地址：

香港中文大學醫學院賽馬會公共衞生及基層醫療學院

Institution
hospital：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

Address：

4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

经费或物资来源：

Health and Medical Research Fund (16170421)

Source(s) of funding：

Health and Medical Research Fund (16170421)

研究疾病：

mild cognitive impairment  

Target disease：

mild cognitive impairment

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The aim of this study is to examine the effectiveness of a complex intervention: cognitive training, mind body physical exercise, and nurse-led risk factor modification (CPR) on reducing cognitive decline among the older adults aged between 60 and 80 years with MCI when compared to health advice (HA) in primary care.  

Objectives of Study：

The aim of this study is to examine the effectiveness of a complex intervention: cognitive training, mind body physical exercise, and nurse-led risk factor modification (CPR) on reducing cognitive decline among the older adults aged between 60 and 80 years with MCI when compared to health advice (HA) in primary care.

药物成份或治疗方案详述：

There will three groups. The first group will be provided with cognitive training, mind body physical exercise, and nurse-led risk factor modification (CPR), The second group will be provided with nurse-led risk factor modification (RFM). The third group will be provided with health advice (HA).  

Description for medicine or protocol of treatment in detail：

There will three groups. The first group will be provided with cognitive training, mind body physical exercise, and nurse-led risk factor modification (CPR), The second group will be provided with nurse-led risk factor modification (RFM). The third group will be provided with health advice (HA).  

纳入标准：

Inclusion criteria

排除标准：

(1) a diagnosis of dementia;
(2) concurrent treatment with structured cognitive training, regular physical exercises including Tai Chi or other lifestyle modifications (e.g., diet) although no restrictions will be imposed on leisure activity;
(3) a past history of bipolar affective disorder or psychosis;
(4) one or more significant communicative impairments.
The use of psychotropic medication; this does NOT constitute an exclusion criterion, but any use of anti-dementia and other psychotropic medications should be kept on a stable dosage for at least three months before enrolment and also throughout the study.

Exclusion criteria：

(2) concurrent treatment with structured cognitive training, regular physical exercises including Tai Chi or other lifestyle modifications (e.g., diet) although no restrictions will be imposed on leisure activity;
(3) a past history of bipolar affective disorder or psychosis;
(4) one or more significant communicative impairments.
The use of psychotropic medication; this does NOT constitute an exclusion criterion, but any use of anti-dementia and other psychotropic medications should be kept on a stable dosage for at least three months before enrolment and also throughout the study.

研究实施时间：

Study execute time：

从 From 2019-11-01 00:00:00至 To 2024-11-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-11-01 00:00:00 至 To 2023-06-01 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 152

Group：

1

Sample size：

干预措施：

cognitive training, mind body physical exercise, and nurse-led risk factor modification (CPR)

干预措施代码：

Intervention：

cognitive training, mind body physical exercise, and nurse-led risk factor modification (CPR)

Intervention code：

组别：

2

样本量：

 152

Group：

2

Sample size：

干预措施：

risk factor modification (RFM)

干预措施代码：

Intervention：

risk factor modification (RFM)

Intervention code：

组别：

3

样本量：

 152

Group：

3

Sample size：

干预措施：

health advice control (HA)

干预措施代码：

Intervention：

health advice control (HA)

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)：

 瀝源健康院 

单位级别：

 無 

Institution
hospital：

Lek Yuen Health Centre

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

The Chinese version of the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog)

指标类型：

主要指标

Outcome：

The Chinese version of the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog)

Type：

Primary indicator

测量时间点：

at baseline, 6, 12 and 15 months post baseline

测量方法：

face to face interview

Measure time point of outcome：

at baseline, 6, 12 and 15 months post baseline

Measure method：

face to face interview

指标中文名：

CDR sum of box

指标类型：

次要指标

Outcome：

CDR sum of box

Type：

Secondary indicator

测量时间点：

at baseline, 6, 12 and 15 months post baseline

测量方法：

face to face interview

Measure time point of outcome：

at baseline, 6, 12 and 15 months post baseline

Measure method：

face to face interview

指标中文名：

The Disability Assessment for Dementia (DAD)

指标类型：

次要指标

Outcome：

The Disability Assessment for Dementia (DAD)

Type：

Secondary indicator

测量时间点：

at baseline, 6, 12 and 15 months post baseline

测量方法：

face to face interview

Measure time point of outcome：

at baseline, 6, 12 and 15 months post baseline

Measure method：

face to face interview

指标中文名：

Quality of life (EQ5D)

指标类型：

次要指标

Outcome：

Quality of life (EQ5D)

Type：

Secondary indicator

测量时间点：

at baseline, 6, 12 and 15 months post baseline

测量方法：

face to face interview

Measure time point of outcome：

at baseline, 6, 12 and 15 months post baseline

Measure method：

face to face interview

指标中文名：

Depression and anxiety

指标类型：

次要指标

Outcome：

Depression and anxiety

Type：

Secondary indicator

测量时间点：

at baseline, 6, 12 and 15 months post baseline

测量方法：

face to face interview

Measure time point of outcome：

at baseline, 6, 12 and 15 months post baseline

Measure method：

face to face interview

指标中文名：

Cigarette smoking, alcohol drinking, diet and physical exercise

指标类型：

次要指标

Outcome：

Cigarette smoking, alcohol drinking, diet and physical exercise

Type：

Secondary indicator

测量时间点：

at baseline, 6, 12 and 15 months post baseline

测量方法：

face to face interview

Measure time point of outcome：

at baseline, 6, 12 and 15 months post baseline

Measure method：

face to face interview

指标中文名：

Health service utilization

指标类型：

次要指标

Outcome：

Health service utilization

Type：

Secondary indicator

测量时间点：

at baseline, 6, 12 and 15 months post baseline

测量方法：

face to face interview

Measure time point of outcome：

at baseline, 6, 12 and 15 months post baseline

Measure method：

face to face interview

指标中文名：

Common diseases

指标类型：

次要指标

Outcome：

Common diseases

Type：

Secondary indicator

测量时间点：

at baseline, 6, 12 and 15 months post baseline

测量方法：

face to face interview

Measure time point of outcome：

at baseline, 6, 12 and 15 months post baseline

Measure method：

face to face interview

指标中文名：

Demographic data

指标类型：

附加指标

Outcome：

Demographic data

Type：

Additional indicator

测量时间点：

at baseline

测量方法：

face to face interview

Measure time point of outcome：

at baseline

Measure method：

face to face interview

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

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 60 岁 years
最大 Max age 80 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）：

Computer-generated allocation sequencing will be done in blocks of eight in each intervention venue to ensure the balanced allocation of participants in each venue. This will be done by a statistician who is independent from the study.

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

Computer-generated allocation sequencing will be done in blocks of eight in each intervention venue to ensure the balanced allocation of participants in each venue. This will be done by a statistician who is independent from the study.

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：

The persons who conduct the assessments or data analyses will be blinded to group allocation.

Blinding：

The persons who conduct the assessments or data analyses will be blinded to group allocation.

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

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）：

Available upon request after trial completion

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

Available upon request after trial completion

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：

Demographic data (sex, age, educational level, and socio-economic status, e.g., household income by household size) will be collected at baseline. All other measures will be collected at baseline, 6, 12 and 15 months. All the data will be locked in a cabinet or saved in pass-word-protected computers to ensure data safety. Only the research team will have the access to the data.

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

Demographic data (sex, age, educational level, and socio-economic status, e.g., household income by household size) will be collected at baseline. All other measures will be collected at baseline, 6, 12 and 15 months. All the data will be locked in a cabinet or saved in pass-word-protected computers to ensure data safety. Only the research team will have the access to the data.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2019-10-24 20:05:59
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