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A randomized controlled trial of combined physical exercise-working memory training on slowing down cognitive decline in elders with mild clinical Alzheimer’s disease
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注册号:

Registration number:

ChiCTR-IOR-15005942 

最近更新日期:

Date of Last Refreshed on:

2016-03-05 

注册时间:

Date of Registration:

2015-02-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

運動訓練與工作記憶訓練對減慢輕度阿氏痴呆症長者認知能力下降之隨機對比研究 

Public title:

A randomized controlled trial of combined physical exercise-working memory training on slowing down cognitive decline in elders with mild clinical Alzheimer’s disease 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

運動訓練與工作記憶訓練對減慢輕度阿氏痴呆症長者認知能力下降之隨機對比研究 

Scientific title:

A randomized controlled trial of combined physical exercise-working memory training on slowing down cognitive decline in elders with mild clinical Alzheimer’s disease 

研究课题代号(代码):

Study subject ID:

2014.566 

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_CCT00445 

申请注册联系人:

鄧穎瑜 

研究负责人:

林翠華 

Applicant:

Ms Harriet W Y Tang 

Study leader:

Prof. Linda CW Lam 

申请注册联系人电话:

Applicant telephone:

+852 28314305 

研究负责人电话:

Study leader's telephone:

+852 26076027 

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:

harriet@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

cwlam@cuhk.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/284 

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/284 

申请注册联系人通讯地址:

Room 3A, Block E, Staff Quarters, Prince of Wales Hospital, 46 Ngan Shing Street, Shatin 

研究负责人通讯地址:

Department of Psychiatry, G/F Multi-Centre, Tai Po Hospital, Tai Po. NT, Hong Kong 

Applicant address:

Room 3A, Block E, Staff Quarters, Prince of Wales Hospital, 46 Ngan Shing Street, Shatin 

Study leader's address:

Department of Psychiatry, G/F Multi-Centre, Tai Po Hospital, Tai Po. NT, 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:

Department of Psychiatry, The Chinese University of Hong Kong 

Applicant's institution:

Department of Psychiatry, 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:

Nil 

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:

The Chinese University of Hong Kong 

Name of the ethic committee:

The Chinese University of Hong Kong 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-12-18 

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:

Department of Psychiatry, The Chinese University of Hong Kong 

Primary sponsor:

Department of Psychiatry, The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

Department of Psychiatry, The Chinese University of Hong Kong 

Primary sponsor's address:

Department of Psychiatry, The Chinese University of 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:

Health and Medical Research Fund 

Source(s) of funding:

Health and Medical Research Fund 

研究疾病:

Mild clinical Alzheimer’s disease 

Target disease:

Mild clinical Alzheimer’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 

研究目的:

運動訓練與工作記憶訓練對減慢輕度阿氏痴呆症長者認知能力下降 

Objectives of Study:

combined physical exercise-working memory training on slowing down cognitive decline in elders with mild clinical Alzheimers' disease. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. Subjects from 60 to 90 years old; 2. DSM-5 diagnosis of Major Neurocognitive Disorder due to AD (22), which would satisfy the criteria for significant cognitive decline in at least one of six areas of cognition (memory, perceptual-motor, complex attention, language, executive function and social cognition) and functional disturbance, with clinical or biological features indicative of AD; 3. CDR of 1 indicating mild dementia; and 4. Ambulatory with low risk of fall as assessed by the physiotherapist (co-A). 

Inclusion criteria

1. Subjects from 60 to 90 years old; 2. DSM-5 diagnosis of Major Neurocognitive Disorder due to AD (22), which would satisfy the criteria for significant cognitive decline in at least one of six areas of cognition (memory, perceptual-motor, complex attention, language, executive function and social cognition) and functional disturbance, with clinical or biological features indicative of AD; 3. CDR of 1 indicating mild dementia; and 4. Ambulatory with low risk of fall as assessed by the physiotherapist (co-A). 

排除标准:

1. Past history of bipolar affective disorder or psychosis; 2. Physical frailty affecting attendance to training sessions; 3. Already attending regular cognitive training; 4. History of major neurological deficit including history of stroke, or traumatic brain injury; and 5. Significant communicative impairments. 

Exclusion criteria:

1. Past history of bipolar affective disorder or psychosis; 2. Physical frailty affecting attendance to training sessions; 3. Already attending regular cognitive training; 4. History of major neurological deficit including history of stroke, or traumatic brain injury; and 5. Significant communicative impairments. 

研究实施时间:

Study execute time:

From2015-02-14To  

干预措施:

Interventions:

组别:

Two groups

样本量:

376

Group:

Two groups

Sample size:

干预措施:

Physical exercise and Working memory training versus either physical exercise (PE) training, working memory (WM) training, combined PE-WM training, or caregiver education in six weeks intervention

干预措施代码:

Intervention:

Physical exercise and Working memory training versus either physical exercise (PE) training, working memory (WM) training, combined PE-WM training, or caregiver education in six weeks intervention

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:

Global cognitive function

指标类型:

主要指标 

Outcome:

Global cognitive function

Type:

Primary indicator 

测量时间点:

baseline, 6th week and 12th weeks

测量方法:

It will be measured by the Chinese version of the Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog)

Measure time point of outcome:

baseline, 6th week and 12th weeks

Measure method:

It will be measured by the Chinese version of the Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog)

指标中文名:

Clinical Dementia Rating (CDR)

指标类型:

次要指标 

Outcome:

Clinical Dementia Rating (CDR)

Type:

Secondary indicator 

测量时间点:

测量方法:

It's a semi-structured clinical interview for the severity of cognitive impairment rated along six dimensions of cognition and function (memory, orientation, judgment & problem solving, community affairs,home, hobbies and personal care. Scores in each dimension are combined to forma global rating ranging from 0 (not

Measure time point of outcome:

Measure method:

It's a semi-structured clinical interview for the severity of cognitive impairment rated along six dimensions of cognition and function (memory, orientation, judgment & problem solving, community affairs,home, hobbies and personal care. Scores in each dimension are combined to forma global rating ranging from 0 (not

指标中文名:

Working memory test

指标类型:

次要指标 

Outcome:

Working memory test

Type:

Secondary indicator 

测量时间点:

at baseline, 6th and 12th weeks

测量方法:

direct measure of improvement in task performance

Measure time point of outcome:

at baseline, 6th and 12th weeks

Measure method:

direct measure of improvement in task performance

指标中文名:

Memory and language tests

指标类型:

次要指标 

Outcome:

Memory and language tests

Type:

Secondary indicator 

测量时间点:

测量方法:

logical memory, 10 minutes list learning delay recall, category verbal fluency and trail making tests would be evaluated to examine the effects of both PE and WM training on other cognitive abilities.

Measure time point of outcome:

Measure method:

logical memory, 10 minutes list learning delay recall, category verbal fluency and trail making tests would be evaluated to examine the effects of both PE and WM training on other cognitive abilities.

指标中文名:

changes in neuropsychiatric symptoms across

指标类型:

次要指标 

Outcome:

changes in neuropsychiatric symptoms across

Type:

Secondary indicator 

测量时间点:

测量方法:

The Chinese Neuropsychiatric Inventory (NPI) would be used. NPI would evaluate potential mood and behavioral changes.

Measure time point of outcome:

Measure method:

The Chinese Neuropsychiatric Inventory (NPI) would be used. NPI would evaluate potential mood and behavioral changes.

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:

测量方法:

functional abilities in both basic and instrumental activities of daily living

Measure time point of outcome:

Measure method:

functional abilities in both basic and instrumental activities of daily living

指标中文名:

Subjective sense of exertion

指标类型:

次要指标 

Outcome:

Subjective sense of exertion

Type:

Secondary indicator 

测量时间点:

测量方法:

Revised Borg Scale will be used

Measure time point of outcome:

Measure method:

Revised Borg Scale will be used

指标中文名:

Quality of Life –AD.

指标类型:

次要指标 

Outcome:

Quality of Life –AD.

Type:

Secondary indicator 

测量时间点:

测量方法:

It is a 13 item instrument adopted as a generic measure for the quality of life in patients with Alzheimer’s disease.

Measure time point of outcome:

Measure method:

It is a 13 item instrument adopted as a generic measure for the quality of life in patients with Alzheimer’s disease.

指标中文名:

Leisure activity participation

指标类型:

次要指标 

Outcome:

Leisure activity participation

Type:

Secondary indicator 

测量时间点:

测量方法:

in order to measure behavioral change after participation of the study

Measure time point of outcome:

Measure method:

in order to measure behavioral change after participation of the study

指标中文名:

Adverse events

指标类型:

次要指标 

Outcome:

adverse event

Type:

Secondary indicator 

测量时间点:

at baseline, 6th week and 12th weeks

测量方法:

Measure time point of outcome:

at baseline, 6th week and 12th weeks

Measure method:

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 60 years
最大 Max age 90 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):

Randomized

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

Randomized

盲法:

Single-blind

Blinding:

Single-blind

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-02-03
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