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A 3-arm Randomized Controlled Trial on the Effects of Dance Movement Intervention and Exercises on Elderly with Early Dementia
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注册号:

Registration number:

ChiCTR-IOR-15006541 

最近更新日期:

Date of Last Refreshed on:

2015-06-11 

注册时间:

Date of Registration:

2015-06-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

 

Public title:

A 3-arm Randomized Controlled Trial on the Effects of Dance Movement Intervention and Exercises on Elderly with Early Dementia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

 

Scientific title:

A 3-arm Randomized Controlled Trial on the Effects of Dance Movement Intervention and Exercises on Elderly with Early Dementia 

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:

 

研究负责人:

 

Applicant:

Jacob Cheung 

Study leader:

Dr. Rainbow Ho 

申请注册联系人电话:

Applicant telephone:

+852 28315173 

研究负责人电话:

Study leader's telephone:

+852 28315169 

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:

cheungjk@hku.hk 

研究负责人电子邮件:

Study leader's E-mail:

tinho@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:

 

研究负责人通讯地址:

 

Applicant address:

2/F, The Hong Kong Jockey Club Building for Interdisciplinary Research 5 Sassoon Road, Pokfulam Hong Kong 

Study leader's address:

2/F, The Hong Kong Jockey Club Building for Interdisciplinary Research 5 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:

 

Applicant's institution:

Centre on Behavioral Health, 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 14-121 

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:

 

Name of the ethic committee:

Institutional Review Board of the University of Hong Kong 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-03-04 

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:

 

Primary sponsor:

Dr. Rainbow Ho 

研究实施负责(组长)单位地址:

 

Primary sponsor's address:

2/F, The Hong Kong Jockey Club Building for Interdisciplinary Research 5 Sassoon Road, Pokfulam Hong Kong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

省(直辖市):

市(区县):

Country:

Hong Kong

Province:

Hong Kong

City:

单位(医院):

具体地址:

Institution
hospital:

The University of Hong Kong

Address:

2/F, The Hong Kong Jockey Club Building for Interdisciplinary Research 5 Sassoon Road, Pokfulam Hong Kong

经费或物资来源:

 

Source(s) of funding:

Research Grants Council, University Grants Committee, General Research Fund 

研究疾病:

 

Target disease:

Dementia 

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:

 

Objectives of Study:

The primary objective of the proposed study is to explore the effects of a dance movement based intervention on dementia-related indicators such as neuropsychiatric symptoms (behavior, psychosis, apathy), psychosocial well-being (depression, loneliness and current affective state), physiological stress (indicated by cortisol), cognitive functioning (executive function, episodic memory, visuospatial construction) and daily functioning. The secondary objectives of this study are to explore the proposed intervention's effect on dementia prognoses and examine how cortisol levels relate to neuropsychiatric, psychosocial, cognitive and functional measures in early dementia. 

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:

 

Inclusion criteria

1. CDR of 0.5–1; 2. Chinese patients aged 65 to 90; 3. Community dwelling; 4. Mobility of at least the upper limbs and body; 5. Sufficient visual and auditory abilities to complete assessments. -Stable doses of medication for at least 30 days before screening. 

排除标准:

 

Exclusion criteria:

1. Concurrent major psychiatric disorder (e.g. major depressive disorder, bipolar disorder, schizophrenia) or drug and alcohol abuse; 2. Severe illness or pain that would lead to significant deterioration in health, or that would limit participation in the interventions (e.g. metastatic cancer, musculoskeletal disorders, etc.). 

研究实施时间:

Study execute time:

FromTo  

干预措施:

Interventions:

组别:

样本量:

67

Group:

Dance Movement

Sample size:

干预措施:

干预措施代码:

Intervention:

Heart Rate from dance movement intervention

Intervention code:

组别:

样本量:

67

Group:

Exercise

Sample size:

干预措施:

干预措施代码:

Intervention:

Heart Rate from mild exercise

Intervention code:

组别:

样本量:

67

Group:

Waitlist Control Group

Sample size:

干预措施:

干预措施代码:

Intervention:

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

 

省(直辖市):

 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

Tung Wah Hospital Group  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

指标类型:

主要指标 

Outcome:

Cognitive functioning

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

Psychosocial wellbeing

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

Neuropsychiatric Symptoms

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

Daily Functioning

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标 

Outcome:

Salivary Cortisol

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:

组织:

Sample Name:

Questionniares

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

3 years

标本中文名:

组织:

Sample Name:

Salivary Cortisol

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

3 years

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 65 years
最大 Max age 100 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

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

Computer generated numbers for randomization

盲法:

Blinding:

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:

 2015-06-11
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