中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2300072788
最近更新日期： Date of Last Refreshed on：	2023-08-23 08:42:29
注册时间： Date of Registration：	2023-06-25 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	Effects of a multicomponent intervention on functional ability in community-dwelling older people: a randomized controlled trial
Public title：	Effects of a multicomponent intervention on functional ability in community-dwelling older people: a randomized controlled trial
注册题目简写：
English Acronym：
研究课题的正式科学名称：	Effects of a multicomponent intervention on functional ability in community-dwelling older people: a randomized controlled trial
Scientific title：	Effects of a multicomponent intervention on functional ability in community-dwelling older people: 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：

申请注册联系人：	Ms. Grace Sin Man LEUNG	研究负责人：	Dr. Ruby Ho Yan YU
Applicant：	Ms. Grace Sin Man LEUNG	Study leader：	Dr. Ruby Ho Yan YU
申请注册联系人电话： Applicant telephone：	+852 3943 0376	研究负责人电话： Study leader's telephone：	+852 3943 5142
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：	gracesmleung@cuhk.edu.hk	研究负责人电子邮件： Study leader's E-mail：	rubyyu@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：	Suite 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong Special Administrative Region, China	研究负责人通讯地址：	Suite 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong Special Administrative Region, China
Applicant address：	Suite 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong Special Administrative Region, China	Study leader's address：	Suite 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong Special Administrative Region, China
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：	CUHK Jockey Club Institute of Ageing
Applicant's institution：	CUHK Jockey Club Institute of Ageing
研究负责人所在单位：	CUHK Jockey Club Institute of Ageing
Affiliation of the Leader：	CUHK Jockey Club Institute of Ageing

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：	CRE Ref. No. 2023.024	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：	Joint CUHK-NTEC Clinical Research Ethics Committee (CREC)
Name of the ethic committee：	Joint CUHK-NTEC Clinical Research Ethics Committee (CREC)
伦理委员会批准日期： Date of approved by ethic committee：	2023-05-15 00:00:00
伦理委员会联系人：	Envy Lee
Contact Name of the ethic committee：	Envy Lee
伦理委员会联系地址：	8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong
Contact Address of the ethic 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 3505 3935	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 Hong Kong Jockey Club Charities Trust

Primary sponsor：

The Hong Kong Jockey Club Charities Trust

研究实施负责（组长）单位地址：

Suite 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong Special Administrative Region, China

Primary sponsor's address：

Suite 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong Special Administrative Region, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	China	省(直辖市)：	Hong Kong Special Administrative Region	市(区县)：
Country：	China	Province：	Hong Kong Special Administrative Region	City：
单位(医院)：	CUHK Jockey Club Institute of Ageing	具体地址：	Suite 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong Special Administrative Region, China
Institution hospital：	CUHK Jockey Club Institute of Ageing	Address：	Suite 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong Special Administrative Region, China

经费或物资来源：

The Hong Kong Jockey Club Charities Trust

Source(s) of funding：

The Hong Kong Jockey Club Charities Trust

研究疾病：

Functional ability

Target disease：

Functional ability

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：

To conduct a 12-week group-based multicomponent intervention for 300 persons aged 60 years or older to improve functional ability, and to promote healthy ageing.

Objectives of Study：

To conduct a 12-week group-based multicomponent intervention for 300 persons aged 60 years or older to improve functional ability, and to promote healthy ageing.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

1. Community-dwelling older men or women aged 60 years and older;
2. Understand Cantonese;
3. With limited mobility without mobility disability (Short Physical Performance Battery score = 3-9);
4. Assessed with possible sarcopenia (low muscle strength (handgrip strength M: < 28 kg, F: < 18 kg) or low physical performance (5-chair rise test >= 12 s));
5. Diagonised with sarcopenia (low appendicular skeletal muscle mass (bioelectrical impedance analysis M: < 7.0kg/m2, F: < 5.7kg/m2) and low muscle strength (handgrip strength M: < 28 kg, F: < 18 kg) and/or low physical performance (5-chair rise test >= 12 s));
6. With history of falls in the past year;
7. With physical pre-frailty/frailty (FRAIL score >= 1);
8. With cognitive impairment (Montreal Cognitive Assessment 5-Minute Protocol Hong Kong Version score <= age and education corrected percentile cutoff, without doctor diagnosed dementia);
9. With impaired vitality (Mini Nutritional Assessment Short-Form score <= 11/low muscle strength (handgrip strength M: < 28 kg, F: < 18 kg).

Inclusion criteria

1. Community-dwelling older men or women aged 60 years and older;
2. Understand Cantonese;
3. With limited mobility without mobility disability (Short Physical Performance Battery score = 3-9);
4. Assessed with possible sarcopenia (low muscle strength (handgrip strength M: < 28 kg, F: < 18 kg) or low physical performance (5-chair rise test >= 12 s));
5. Diagonised with sarcopenia (low appendicular skeletal muscle mass (bioelectrical impedance analysis M: < 7.0kg/m2, F: < 5.7kg/m2) and low muscle strength (handgrip strength M: < 28 kg, F: < 18 kg) and/or low physical performance (5-chair rise test >= 12 s));
6. With history of falls in the past year;
7. With physical pre-frailty/frailty (FRAIL score >= 1);
8. With cognitive impairment (Montreal Cognitive Assessment 5-Minute Protocol Hong Kong Version score <= age and education corrected percentile cutoff, without doctor diagnosed dementia);
9. With impaired vitality (Mini Nutritional Assessment Short-Form score <= 11/low muscle strength (handgrip strength M: < 28 kg, F: < 18 kg).

排除标准：

1. Unable to get up from a chair (with or without using the armrests) and stand for 20 seconds; 2. Receive treatment for medical conditions that preclude physical activity; 3. Diagnosis of dementia, dementia suspected by a clinician, or terminal illness; 4. Interviewer-adjudicated severe visual or hearing impairment; 5. Participation in a structured physical activity program, nutritional activities or board game activities; 6. Contraindications to safely engage in trial activities as judged by health professionals (e.g., doctors, nurses, physiotherapists etc.).

Exclusion criteria：

1. Unable to get up from a chair (with or without using the armrests) and stand for 20 seconds; 2. Receive treatment for medical conditions that preclude physical activity; 3. Diagnosis of dementia, dementia suspected by a clinician, or terminal illness; 4. Interviewer-adjudicated severe visual or hearing impairment; 5. Participation in a structured physical activity program, nutritional activities or board game activities; 6. Contraindications to safely engage in trial activities as judged by health professionals (e.g., doctors, nurses, physiotherapists etc.).

研究实施时间：

Study execute time：

从 From 2023-07-01 00:00:00至 To 2024-06-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-07-01 00:00:00 至 To 2024-03-31 00:00:00

干预措施：

Interventions：

组别：	1	样本量：	100
Group：	1	Sample size：	100
干预措施：	Multicomponent intervention group without goal-setting	干预措施代码：
Intervention：	Multicomponent intervention group without goal-setting	Intervention code：

组别：	2	样本量：	100
Group：	2	Sample size：	100
干预措施：	Multicomponent intervention group with goal-setting	干预措施代码：
Intervention：	Multicomponent intervention group with goal-setting	Intervention code：

组别：	3	样本量：	100
Group：	3	Sample size：	100
干预措施：	receiving the HLE program	干预措施代码：
Intervention：	receiving the HLE program	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	China	省(直辖市)：	Hong Kong Special Administrative Region	市(区县)：
Country：	China	Province：	Hong Kong Special Administrative Region	City：
单位(医院)：	CUHK Jockey Club Institute of Ageing	单位级别：	N/A
Institution hospital：	CUHK Jockey Club Institute of Ageing	Level of the institution：	N/A

测量指标：

Outcomes：

指标中文名：	Balance	指标类型：	主要指标
Outcome：	Balance	Type：	Primary indicator
测量时间点：	Pre-, mid- and post-intervention	测量方法：	Balance test
Measure time point of outcome：	Pre-, mid- and post-intervention	Measure method：	Balance test

指标中文名：	Gait speed	指标类型：	主要指标
Outcome：	Gait speed	Type：	Primary indicator
测量时间点：	Pre-, mid- and post-intervention	测量方法：	4-meter gait speed test
Measure time point of outcome：	Pre-, mid- and post-intervention	Measure method：	4-meter gait speed test

指标中文名：	Muscle endurance	指标类型：	主要指标
Outcome：	Muscle endurance	Type：	Primary indicator
测量时间点：	Pre-, mid- and post-intervention	测量方法：	5-chair rise test
Measure time point of outcome：	Pre-, mid- and post-intervention	Measure method：	5-chair rise test

指标中文名：	Grip strength	指标类型：	次要指标
Outcome：	Grip strength	Type：	Secondary indicator
测量时间点：	Pre-, mid- and post-intervention	测量方法：	Dynamometer
Measure time point of outcome：	Pre-, mid- and post-intervention	Measure method：	Dynamometer

指标中文名：	Knee extension strength	指标类型：	次要指标
Outcome：	Knee extension strength	Type：	Secondary indicator
测量时间点：	Pre-, mid- and post-intervention	测量方法：	Dynamometer
Measure time point of outcome：	Pre-, mid- and post-intervention	Measure method：	Dynamometer

指标中文名：	Cardiovascular fitness	指标类型：	次要指标
Outcome：	Cardiovascular fitness	Type：	Secondary indicator
测量时间点：	Pre-, mid- and post-intervention	测量方法：	3-min step test
Measure time point of outcome：	Pre-, mid- and post-intervention	Measure method：	3-min step test

指标中文名：	Appendicular skeletal muscle index	指标类型：	次要指标
Outcome：	Appendicular skeletal muscle index	Type：	Secondary indicator
测量时间点：	Pre-, mid- and post-intervention	测量方法：	Bioelectrical impedance analysis
Measure time point of outcome：	Pre-, mid- and post-intervention	Measure method：	Bioelectrical impedance analysis

指标中文名：	Risk of falls	指标类型：	次要指标
Outcome：	Risk of falls	Type：	Secondary indicator
测量时间点：	Pre-, mid- and post-intervention	测量方法：	Time up and go test
Measure time point of outcome：	Pre-, mid- and post-intervention	Measure method：	Time up and go test

指标中文名：	Sarcopenia-specific Quality of Life	指标类型：	次要指标
Outcome：	Sarcopenia-specific Quality of Life	Type：	Secondary indicator
测量时间点：	Pre-, and post-intervention	测量方法：	SarQoL
Measure time point of outcome：	Pre-, and post-intervention	Measure method：	SarQoL

指标中文名：	Frailty	指标类型：	次要指标
Outcome：	Frailty	Type：	Secondary indicator
测量时间点：	Pre-, mid- and post-intervention	测量方法：	FRAIL scale
Measure time point of outcome：	Pre-, mid- and post-intervention	Measure method：	FRAIL scale

指标中文名：	Global cognitive function	指标类型：	次要指标
Outcome：	Global cognitive function	Type：	Secondary indicator
测量时间点：	Pre-, and post-intervention	测量方法：	Montreal Cognitive Assessment-5min
Measure time point of outcome：	Pre-, and post-intervention	Measure method：	Montreal Cognitive Assessment-5min

指标中文名：	Executive function	指标类型：	次要指标
Outcome：	Executive function	Type：	Secondary indicator
测量时间点：	Pre-, and post-intervention	测量方法：	The Frontal Assessment Battery
Measure time point of outcome：	Pre-, and post-intervention	Measure method：	The Frontal Assessment Battery

指标中文名：	Nutritional status	指标类型：	次要指标
Outcome：	Nutritional status	Type：	Secondary indicator
测量时间点：	Pre-, and post-intervention	测量方法：	Mini Nutritional Assessment-Short Form
Measure time point of outcome：	Pre-, and post-intervention	Measure method：	Mini Nutritional Assessment-Short Form

指标中文名：	Depression	指标类型：	次要指标
Outcome：	Depression	Type：	Secondary indicator
测量时间点：	Pre-, and post-intervention	测量方法：	Geriatric Depression Scale
Measure time point of outcome：	Pre-, and post-intervention	Measure method：	Geriatric Depression Scale

指标中文名：	Subjective well-being	指标类型：	次要指标
Outcome：	Subjective well-being	Type：	Secondary indicator
测量时间点：	Pre-, and post-intervention	测量方法：	Evaluative wellbeing (or life satisfaction), hedonic wellbeing (feelings of happiness), and eudemonic wellbeing (sense of purpose and meaning in life)
Measure time point of outcome：	Pre-, and post-intervention	Measure method：	Evaluative wellbeing (or life satisfaction), hedonic wellbeing (feelings of happiness), and eudemonic wellbeing (sense of purpose and meaning in life)

指标中文名：	Self-rated health	指标类型：	次要指标
Outcome：	Self-rated health	Type：	Secondary indicator
测量时间点：	Pre-, mid- and post-intervention	测量方法：	Self-rated health scale
Measure time point of outcome：	Pre-, mid- and post-intervention	Measure method：	Self-rated health scale

指标中文名：	Functional status	指标类型：	次要指标
Outcome：	Functional status	Type：	Secondary indicator
测量时间点：	Pre-, and post-intervention	测量方法：	Instrumental Activities of Daily Living
Measure time point of outcome：	Pre-, and post-intervention	Measure method：	Instrumental Activities of Daily Living

指标中文名：	Pain	指标类型：	次要指标
Outcome：	Pain	Type：	Secondary indicator
测量时间点：	Pre-, mid- and post-intervention	测量方法：	Questionnaire
Measure time point of outcome：	Pre-, mid- and post-intervention	Measure method：	Questionnaire

指标中文名：	History of falls	指标类型：	次要指标
Outcome：	History of falls	Type：	Secondary indicator
测量时间点：	Pre-, and post-intervention	测量方法：	Questionnaire
Measure time point of outcome：	Pre-, and post-intervention	Measure method：	Questionnaire

指标中文名：	Hospitalization	指标类型：	次要指标
Outcome：	Hospitalization	Type：	Secondary indicator
测量时间点：	Pre-, and post-intervention	测量方法：	Questionnaire
Measure time point of outcome：	Pre-, and post-intervention	Measure method：	Questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	N/A	组织：
Sample Name：	N/A	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	Note：

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）：

To obtain an adequate sample size, community centres under the eHealth project with the largest number of participants who have orare at risk of sarcopenia will be selected. Fifteen centres will be randomly selected and allocated to either group 1(receiving the multicomponent intervention without goal-setting), group 2 (receiving the multicomponent intervention with goal-setting), or group 3 (receiving the HLE program). We choose cluster RCT because randomization at the cluster (centre) level will reduce the likelihood of experimental contamination. Group 1 - receiving the multicomponent intervention without goal-setting. Group 2 - receiving the multicomponent intervention with goal-setting. Group 3 - receiving the HLE program.

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

To obtain an adequate sample size, community centres under the eHealth project with the largest number of participants who have orare at risk of sarcopenia will be selected. Fifteen centres will be randomly selected and allocated to either group 1(receiving the multicomponent intervention without goal-setting), group 2 (receiving the multicomponent intervention with goal-setting), or group 3 (receiving the HLE program). We choose cluster RCT because randomization at the cluster (centre) level will reduce the likelihood of experimental contamination. Group 1 - receiving the multicomponent intervention without goal-setting. Group 2 - receiving the multicomponent intervention with goal-setting. Group 3 - receiving the HLE program.

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：	Not stated
Blinding：	Not stated
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	N/A
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	N/A
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：	N/A
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	N/A
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2023-06-25 17:14:38