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評估踏板運動對提高輕度認知障礙患者認知功能、改善抑鬱及生活質量的效果研究
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注册号：

Registration number：

 ChiCTR-IOR-16009300 

最近更新日期：

Date of Last Refreshed on：

 2016-09-30 20:05:59 

注册时间：

Date of Registration：

 2016-09-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

評估踏板運動對提高輕度認知障礙患者認知功能、改善抑鬱及生活質量的效果研究

Public title：

The effectiveness of a moderate-intensity stepping exercise program on cognitive and psychological outcomes of Chinese elders with mild cognitive impairment : A randomized controlled trial

注册题目简写：

English Acronym：

Aerobic stepping for mild cognitive impairment

研究课题的正式科学名称：

評估踏板運動對提高輕度認知障礙患者認知功能、改善抑鬱及生活質量的效果研究

Scientific title：

The effectiveness of a moderate-intensity stepping exercise program on cognitive and psychological outcomes of Chinese elders with mild cognitive impairment : A randomized 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：

CUHK_CCRB00531

申请注册联系人：

Song Dan 

研究负责人：

Song Dan 

Applicant：

Song Dan 

Study leader：

Song Dan 

申请注册联系人电话：

Applicant telephone：

 +852 39439307

研究负责人电话：

Study leader's
telephone：

+852 39439307

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：

 songdan@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 songdan@link.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/401

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/401

申请注册联系人通讯地址：

Rm 601, Esther Lee Building, the Nethersole School of Nursing, the Chinese University of Hong Kong

研究负责人通讯地址：

Rm 601, Esther Lee Building, the Nethersole School of Nursing, the Chinese University of Hong Kong

Applicant address：

Rm 601, Esther Lee Building, the Nethersole School of Nursing, the Chinese University of Hong Kong

Study leader's address：

Rm 601, Esther Lee Building, the Nethersole School of Nursing, the Chinese University of 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：

The Nethersole School of Nursing, the Chinese University of Hong Kong

Applicant's institution：

The Nethersole School of Nursing, the Chinese University of Hong Kong

研究负责人所在单位：

The Nethersole School of Nursing, the Chinese University of Hong Kong

Affiliation of the Leader：

The Nethersole School of Nursing, 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：

 2016.287-T

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：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2016-09-19 00:00:00

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：

The Nethersole School of Nursing, the Chinese University of Hong Kong

Primary sponsor：

The Nethersole School of Nursing, the Chinese University of Hong Kong

研究实施负责（组长）单位地址：

The Nethersole School of Nursing, the Chinese University of Hong Kong

Primary sponsor's address：

The Nethersole School of Nursing, 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：

None

Source(s) of funding：

None

研究疾病：

輕度認知障礙  

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

評估踏板運動對提高輕度認知障礙患者認知功能、改善抑鬱及生活質量的效果  

Objectives of Study：

To determine the effects of moderate-intensity stepping exercise program on cognitive function, depressive symptoms and health-related quality of life in MCI patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1. individuals who have a diagnosed psychiatric condition at enrollment except depression;
2. individual who are taking anti-depressant agent which confounds the psychological outcomes;
3. individuals who have severe neurological disorders(e.g. stroke, Parkinson's disease);
4. individuals who have contraindications to exercise training, including myocardial infarction or cardiac surgery within six months, unstable angina, uncontrolled arrhythmia, acute congestive heart failure, third degree heart block, and uncontrolled diabetes mellitus;
5. individuals who have acute exacerbation of osteoarthritis;
6. individuals who have impaired hearing or vision which hinders them from answering the questionnaires;
7. individuals who have malignant conditions, such as cancer and HIV, which may be associated with response bias;
8. individuals who have regular participation in more than 150 minutes /week of planned exercise of any kind.

Exclusion criteria：

1. individuals who have a diagnosed psychiatric condition at enrollment except depression;
2. individual who are taking anti-depressant agent which confounds the psychological outcomes;
3. individuals who have severe neurological disorders(e.g. stroke, Parkinson's disease);
4. individuals who have contraindications to exercise training, including myocardial infarction or cardiac surgery within six months, unstable angina, uncontrolled arrhythmia, acute congestive heart failure, third degree heart block, and uncontrolled diabetes mellitus;
5. individuals who have acute exacerbation of osteoarthritis;
6. individuals who have impaired hearing or vision which hinders them from answering the questionnaires;
7. individuals who have malignant conditions, such as cancer and HIV, which may be associated with response bias;
8. individuals who have regular participation in more than 150 minutes /week of planned exercise of any kind.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-03-01 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 120

Group：

Two groups

Sample size：

干预措施：

16-week program, with three 60-minute group sessions (group size: around 10) per week of moderate-intensity aerobic stepping exercise versus health education classes bi-weekly session for 16 weeks

干预措施代码：

Intervention：

16-week program, with three 60-minute group sessions (group size: around 10) per week of moderate-intensity aerobic stepping exercise versus health education classes bi-weekly session for 16 weeks

Intervention code：

组别：

Description of the intervention

样本量：

 0

Group：

Description of the intervention

Sample size：

干预措施：

The proposed exercise intervention is a supervised, group-format, moderate- intensity aerobic stepping exercise located on the indoor area in the community healthcare center.

干预措施代码：

Intervention：

The proposed exercise intervention is a supervised, group-format, moderate- intensity aerobic stepping exercise located on the indoor area in the community healthcare center.

Intervention code：

组别：

(continue)

样本量：

 0

Group：

(continue)

Sample size：

干预措施：

The program is consistent with the current guidelines of exercises for the older adults which recommend at least 150 minutes moderate-intensity aerobic exercise per week . The program will be implemented three sessions per week, 60 minutes per session.

干预措施代码：

Intervention：

The program is consistent with the current guidelines of exercises for the older adults which recommend at least 150 minutes moderate-intensity aerobic exercise per week . The program will be implemented three sessions per week, 60 minutes per session.

Intervention code：

组别：

(continue)

样本量：

 0

Group：

(continue)

Sample size：

干预措施：

Each session starts with a 10-minute warm-up period using self-paced walking and static stretching from head to toe, and followed by a session of moderate-intensity stepping exercise.

干预措施代码：

Intervention：

Each session starts with a 10-minute warm-up period using self-paced walking and static stretching from head to toe, and followed by a session of moderate-intensity stepping exercise.

Intervention code：

组别：

(continue)

样本量：

 0

Group：

(continue)

Sample size：

干预措施：

The stepping exercise involves step-on and step-off using a 10–cm high step bench; the bench is specifically designed for stepping exercise which is stable, skid-proof and has a bearing capacity of 200 kilograms;

干预措施代码：

Intervention：

The stepping exercise involves step-on and step-off using a 10–cm high step bench; the bench is specifically designed for stepping exercise which is stable, skid-proof and has a bearing capacity of 200 kilograms;

Intervention code：

组别：

(continue)

样本量：

 0

Group：

(continue)

Sample size：

干预措施：

the height of 10 cm is chosen because bench height is associated with mechanical load and this 10 cm high bench can reduce the risks of injury for the beginners and is suitable for elderly who are less physically active or have reduced joint flexibility .

干预措施代码：

Intervention：

the height of 10 cm is chosen because bench height is associated with mechanical load and this 10 cm high bench can reduce the risks of injury for the beginners and is suitable for elderly who are less physically active or have reduced joint flexibility .

Intervention code：

组别：

(continue)

样本量：

 0

Group：

(continue)

Sample size：

干预措施：

Upper limb movement will be added concurrently to facilitate overall body exercise. To enhance adherence and avoid injury risks, the exercise program will be introduced in a progressive manner with the duration gradually increasing from 20 minutes to the targeted 40 minutes in four weeks’ time.

干预措施代码：

Intervention：

Upper limb movement will be added concurrently to facilitate overall body exercise. To enhance adherence and avoid injury risks, the exercise program will be introduced in a progressive manner with the duration gradually increasing from 20 minutes to the targeted 40 minutes in four weeks’ time.

Intervention code：

组别：

(continue)

样本量：

 0

Group：

(continue)

Sample size：

干预措施：

Subjects will perform the bench stepping exercise in multiple bouts of at least 10 minutes each rather than in a single continuous bout to reach the targeted duration.

干预措施代码：

Intervention：

Subjects will perform the bench stepping exercise in multiple bouts of at least 10 minutes each rather than in a single continuous bout to reach the targeted duration.

Intervention code：

组别：

(continue)

样本量：

 0

Group：

(continue)

Sample size：

干预措施：

Moderate-intensity exercise will be monitored by a combination of the Borg Rate of Perceived Exertion (Borg RPE) and talk test. Borg RPE is a 15-point scale with scores ranging from 6-20, with higher scores indicating more perceived exertion.

干预措施代码：

Intervention：

Moderate-intensity exercise will be monitored by a combination of the Borg Rate of Perceived Exertion (Borg RPE) and talk test. Borg RPE is a 15-point scale with scores ranging from 6-20, with higher scores indicating more perceived exertion.

Intervention code：

组别：

(continue)

样本量：

 0

Group：

(continue)

Sample size：

干预措施：

Physical activity that results in a rating of 12-14 (descriptor: “somewhat hard”) on the Borg RPE is identified as reaching a moderate intensity.

干预措施代码：

Intervention：

Physical activity that results in a rating of 12-14 (descriptor: “somewhat hard”) on the Borg RPE is identified as reaching a moderate intensity.

Intervention code：

组别：

(continue)

样本量：

 0

Group：

(continue)

Sample size：

干预措施：

The investigator will explain the Borg RPE scale to the subjects and instruct them to adjust their pace in order to achieve a feeling of ‘somewhat hard’ at the Borg RPE rating of 12-14.

干预措施代码：

Intervention：

The investigator will explain the Borg RPE scale to the subjects and instruct them to adjust their pace in order to achieve a feeling of ‘somewhat hard’ at the Borg RPE rating of 12-14.

Intervention code：

组别：

(continue)

样本量：

 0

Group：

(continue)

Sample size：

干预措施：

In addition to the Borg RPE, talk test will also be employed to monitor exercise intensity, by which subjects being able to talk with some slight effort during the training indicates that the intensity is appropriate, if talking is very difficult, the intensity would be too high.

干预措施代码：

Intervention：

In addition to the Borg RPE, talk test will also be employed to monitor exercise intensity, by which subjects being able to talk with some slight effort during the training indicates that the intensity is appropriate, if talking is very difficult, the intensity would be too high.

Intervention code：

组别：

(continue)

样本量：

 0

Group：

(continue)

Sample size：

干预措施：

RPE combined with the talk test is recommended as effective and practical method to monitor aerobic intensity. The training session will end with a 10-minute cool down session with self-paced walking and static stretching.

干预措施代码：

Intervention：

RPE combined with the talk test is recommended as effective and practical method to monitor aerobic intensity. The training session will end with a 10-minute cool down session with self-paced walking and static stretching.

Intervention code：

组别：

(continue)

样本量：

 0

Group：

(continue)

Sample size：

干预措施：

Vital signs including heart rate and blood pressure will be assessed before and after the training to detect those abnormal subjects for safety sake . Attendance and adverse events will be recorded. The PI (Register Nurse) and staff in the community healthcare center will manage any adverse events.

干预措施代码：

Intervention：

Vital signs including heart rate and blood pressure will be assessed before and after the training to detect those abnormal subjects for safety sake . Attendance and adverse events will be recorded. The PI (Register Nurse) and staff in the community healthcare center will manage any adverse events.

Intervention code：

组别：

Description of the Comparative Treatments

样本量：

 0

Group：

Description of the Comparative Treatments

Sample size：

干预措施：

In order to enhance the internal validity of the study findings, an attention placebo will be administered to the participants in the control group to allow for a placebo effect. Control groups subjects will receive eight bi-weekly health education classes, which lasted about 45-60 minutes per session.

干预措施代码：

Intervention：

In order to enhance the internal validity of the study findings, an attention placebo will be administered to the participants in the control group to allow for a placebo effect. Control groups subjects will receive eight bi-weekly health education classes, which lasted about 45-60 minutes per session.

Intervention code：

组别：

(continue)

样本量：

 0

Group：

(continue)

Sample size：

干预措施：

The topics of education classes include health preservation of traditional Chinese medicine, self-management of chronic illness, fall prevention, oral health, skin health, constipation management, pain management, and cataract.

干预措施代码：

Intervention：

The topics of education classes include health preservation of traditional Chinese medicine, self-management of chronic illness, fall prevention, oral health, skin health, constipation management, pain management, and cataract.

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 Nethersole School of Nursing, the Chinese University of Hong Kong 

单位级别：

 The Nethersole School of Nursing, the Chinese University of Hong Kong 

Institution
hospital：

The Nethersole School of Nursing, the Chinese University of Hong Kong

Level of the institution：

The Nethersole School of Nursing, the Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

cognitive function

指标类型：

主要指标

Outcome：

cognitive function

Type：

Primary indicator

测量时间点：

pre-test and post-test

测量方法：

Montreal cognitive assessmnet

Measure time point of outcome：

pre-test and post-test

Measure method：

Montreal cognitive assessmnet

指标中文名：

depressive symptoms

指标类型：

次要指标

Outcome：

depressive symptoms

Type：

Secondary indicator

测量时间点：

pre-test and post-test

测量方法：

Geriatric depression scale

Measure time point of outcome：

pre-test and post-test

Measure method：

Geriatric depression scale

指标中文名：

health-related quality of life

指标类型：

次要指标

Outcome：

health-related quality of life

Type：

Secondary indicator

测量时间点：

pre-test and post-test

测量方法：

Quality of Life –Alzheimer’s disease

Measure time point of outcome：

pre-test and post-test

Measure method：

Quality of Life –Alzheimer’s disease

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 岁 years
最大 Max age 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）：

Block randomisation with a block size of 20

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

Block randomisation with a block size of 20

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：

Single-blind for Investigator/research team

Blinding：

Single-blind for Investigator/research team

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

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：

注册人：

Name of Registration：

  2016-09-30 20:05:59
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