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Sarcopenia and oral frailty in long-term care residents with sight loss: A Clinical Perspective
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注册号:

Registration number:

ChiCTR2200055126 

最近更新日期:

Date of Last Refreshed on:

2022-01-01 

注册时间:

Date of Registration:

2022-01-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请于伦理委员会批准后才开始征募参试者,并与我们联系上传伦理批件。 Sarcopenia and oral frailty in long-term care residents with sight loss: A Clinical Perspective 

Public title:

Sarcopenia and oral frailty in long-term care residents with sight loss: A Clinical Perspective 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Relationship between sarcopenia and oral frailty in long-term care residents with sight loss 

Scientific title:

Relationship between sarcopenia and oral frailty in long-term care residents with sight loss 

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:

Armstrong Chiu Tat San 

研究负责人:

Armstrong Chiu Tat San 

Applicant:

Armstrong Chiu Tat San 

Study leader:

Armstrong Chiu Tat San 

申请注册联系人电话:

Applicant telephone:

+852 3723 8382 

研究负责人电话:

Study leader's telephone:

+852 3723 8382 

申请注册联系人传真 :

Applicant Fax:

+852 3723 8382 

研究负责人传真:

Study leader's fax:

+852 3723 8382 

申请注册联系人电子邮件:

Applicant E-mail:

armstrong.chiu@hksb.org.hk 

研究负责人电子邮件:

Study leader's E-mail:

armstrong.chiu@hksb.org.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

https://www.hksb.org.hk/en/service/231327/KowloonHomefortheAgedBlind/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://www.hksb.org.hk/en/service/231327/KowloonHomefortheAgedBlind/ 

申请注册联系人通讯地址:

Kowloon Home for the Aged Blind, W702, 7/F, West Wing, 248 Nam Cheong Street Shumshuipo, Kowloon, Hong Kong, China 

研究负责人通讯地址:

Kowloon Home for the Aged Blind, W702, 7/F, West Wing, 248 Nam Cheong Street Shumshuipo, Kowloon, Hong Kong, China 

Applicant address:

Kowloon Home for the Aged Blind, W702, 7/F, West Wing, 248 Nam Cheong Street Shumshuipo, Kowloon, Hong Kong, China 

Study leader's address:

Kowloon Home for the Aged Blind, W702, 7/F, West Wing, 248 Nam Cheong Street Shumshuipo, Kowloon, Hong Kong, 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:

香港九龍盲人安老院 

Applicant's institution:

Kowloon Home for the Aged Blind 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

N/A 

Primary sponsor:

N/A 

研究实施负责(组长)单位地址:

N/A 

Primary sponsor's address:

N/A 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

N/A 

Source(s) of funding:

N/As 

研究疾病:

Sacropenia 

Target disease:

Sarcopenia 

研究疾病代码:

M62.84 

Target disease code:

M62.84 

研究类型:

卫生服务研究 

Study type:

Health services reaserch 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

This was a cross-sectional design study that aimed at comparing the tongue thickness between healthy people and older individuals with sarcopenia. 

Objectives of Study:

This was a cross-sectional design study that aimed at comparing the tongue thickness between healthy people and older individuals with sarcopenia. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

The tongue thickness of the subjects was examined by the MIRUKO ? Portable Ultrasound (Nippon Sigmax Co. Ltd, Tokyo, Japan). The average of distance between the midpoint of the lower end of the geniohyoid muscle to the tongue dorsum calculated during the three trials was considered to be the tongue thickness. Muscle mass, Skeletal Muscle Mass(SMM), and skeletal muscle index (SMI) was measured by bioelectrical impedance analysis (BIA) using InBody S10 (InBody Co. Ltd, Seoul, Korea).  

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

The inclusion and exclusion criteria for the healthy subject group were i) aged 18 or above; ii) normal BMI ranged from 18.5-24.9; (iii) no diagnosis and history of sarcopenia; (iv). able to give written consent. The inclusion and exclusion criteria for the sarcopenia group were i) aged 18 or above; (ii) have confirmed diagnosis of sarcopenia; (iii); able to give written consent 

Inclusion criteria

The inclusion and exclusion criteria for the healthy subject group were i) aged 18 or above; ii) normal BMI ranged from 18.5-24.9; (iii) no diagnosis and history of sarcopenia; (iv). able to give written consent. The inclusion and exclusion criteria for the sarcopenia group were i) aged 18 or above; (ii) have confirmed diagnosis of sarcopenia; (iii); able to give written consent 

排除标准:

Older indiviual Subjects with a diagnosis of dementia, dysphagia, and other chronic diseases or subjects with oral abnormalities and maxillofacial dysfunction were excluded. Same as the healthy subject group, subjects a diagnosis of dementia, dysphagia, and other chronic diseases or subjects with oral abnormalities and maxillofacial dysfunction were excluded. 

Exclusion criteria:

Older indiviual Subjects with a diagnosis of dementia, dysphagia, and other chronic diseases or subjects with oral abnormalities and maxillofacial dysfunction were excluded. Same as the healthy subject group, subjects a diagnosis of dementia, dysphagia, and other chronic diseases or subjects with oral abnormalities and maxillofacial dysfunction were excluded. 

研究实施时间:

Study execute time:

From2021-04-01To 2022-12-30 

征募观察对象时间:

Recruiting time:

From2022-04-01To 2023-04-01 

干预措施:

Interventions:

组别:

Older Individuals with Sarcopenia

样本量:

60

Group:

Older Individuals with Sarcopenia

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

Healthy Subject

样本量:

60

Group:

Healthy Subject

Sample size:

干预措施:

S10 and ultrasound

干预措施代码:

Intervention:

S10 and ultrasound

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

香港盲人輔導會 

单位级别:

香港盲人輔導會 

Institution
hospital:

The Hong Kong Society for the Blind  

Level of the institution:

The Hong Kong Society for the Blind 

测量指标:

Outcomes:

指标中文名:

Tongue thickness

指标类型:

主要指标 

Outcome:

Tongue thickness

Type:

Primary indicator 

测量时间点:

Once off

测量方法:

ultrasound imaging

Measure time point of outcome:

Once off

Measure method:

ultrasound imaging

指标中文名:

SKI/ SMM/lean muscle mass

指标类型:

主要指标 

Outcome:

SKI/ SMM/lean muscle mass

Type:

Primary indicator 

测量时间点:

Once off

测量方法:

Body composition machine

Measure time point of outcome:

Once off

Measure method:

Body composition machine

指标中文名:

Weight/Height/BMI

指标类型:

主要指标 

Outcome:

Weight/Height/BMI

Type:

Primary indicator 

测量时间点:

Once off

测量方法:

Scale

Measure time point of outcome:

Once off

Measure method:

Scale

指标中文名:

Hand grip

指标类型:

主要指标 

Outcome:

Hand grip

Type:

Primary indicator 

测量时间点:

Once off

测量方法:

Jamar

Measure time point of outcome:

Once off

Measure method:

Jamar

指标中文名:

Tongue and Lip Strength

指标类型:

主要指标 

Outcome:

Tongue and Lip Strength

Type:

Primary indicator 

测量时间点:

Once off

测量方法:

IOPI

Measure time point of outcome:

Once off

Measure method:

IOPI

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

imaging

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 95 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):

a population-based sample of male and female were recruited by convenience sampling. Random numbers will be generated by computer software and based on the random number generated

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

a population-based sample of male and female were recruited by convenience sampling. Random numbers will be generated by computer software and based on the random number generated

盲法:

Not stated

Blinding:

Not stated

是否共享原始数据:

IPD sharing

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):

contact the PI of the study

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

contact the PI of the study

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 record form and encrypted computer data file

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

Data record form and encrypted computer data file

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-01-01
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