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Promoting healthy ageing through light volleyball intervention in Hong Kong: study protocol for a randomised controlled trial
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注册号:

Registration number:

ChiCTR1900026657 

最近更新日期:

Date of Last Refreshed on:

2019-10-17 

注册时间:

Date of Registration:

2019-10-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

Promoting healthy ageing through light volleyball intervention in Hong Kong: study protocol for a randomised controlled trial 

Public title:

Promoting healthy ageing through light volleyball intervention in Hong Kong: study protocol for a randomised controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Promoting healthy ageing through light volleyball intervention in Hong Kong: study protocol for a randomised controlled trial 

Scientific title:

Promoting healthy ageing through light volleyball intervention in Hong Kong: study protocol for a randomised controlled trial 

研究课题代号(代码):

Study subject ID:

R2010-18 

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:

Ka Man Leung 

研究负责人:

Ka Man Leung 

Applicant:

Ka Man Leung 

Study leader:

Ka Man Leung 

申请注册联系人电话:

Applicant telephone:

+852 34118033 

研究负责人电话:

Study leader's telephone:

+852 34118033 

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:

kmleung@hkbu.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

kmleung@hkbu.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:

中國香港特別行政區九龍九龍塘浸會大學道15號學術與管理大樓AAB 917 

研究负责人通讯地址:

中國香港特別行政區九龍九龍塘浸會大學道15號學術與管理大樓AAB 917 

Applicant address:

AAB 917, Academic and Administration Building, 15 Baptist University Road, Baptist University Road Campus, Kowloon Tong, Kowloon, Hong Kong, China 

Study leader's address:

AAB 917, Academic and Administration Building, 15 Baptist University Road, Baptist University Road Campus, Kowloon Tong, 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:

香港浸會大學 

Applicant's institution:

Hong Kong Baptist University 

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:

REC/18-19/0056 

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:

研究倫理委員會 

Name of the ethic committee:

Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-09-28 

伦理委员会联系人:

Research Ethics Committee 

Contact Name of the ethic committee:

Research Ethics Committee 

伦理委员会联系地址:

Research Ethics Committee 

Contact Address of the ethic committee:

Research Ethics Commitee 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+852 34115127 

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:

University Grants Committee 

Primary sponsor:

University Grants Committee  

研究实施负责(组长)单位地址:

7/F Shui On Centre.6-8 Harbour Road, Wan Chai, Hong Kong, China 

Primary sponsor's address:

7/F Shui On Centre.6-8 Harbour Road, Wan Chai, Hong Kong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

Research Impact Fund 

Source(s) of funding:

Research Impact Fund 

研究疾病:

aging 

Target disease:

aging 

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:

The study aims to investigate the effectiveness of Light Volleyball (LVB) intervention on physical and psychological health attributes among older adults at a larger scale in Hong Kong, the study will compare the effectiveness of LVB with Taichi and control group 

Objectives of Study:

The study aims to investigate the effectiveness of Light Volleyball (LVB) intervention on physical and psychological health attributes among older adults at a larger scale in Hong Kong, the study will compare the effectiveness of LVB with Taichi and control group 

药物成份或治疗方案详述:

About 315 participants will be randomly assigned into LVB group, TC group and control group in 1:1:1 ratio. Data will be collected at baseline (pretest), after a 16-week intervention (posttest), and 6 months and 12 months after intervention. The intervention will be based on the previous program specifically designed for older adults in LVB [17] and in TC [18]. Each program consists of 32 training sessions, with 2 x 90-minutes sessions per week. The duration of the proposed intervention is consistent with the recommendation of U.S. Department of Health and Human Services, HHS [22]. The LVB Groups program will be delivered by registered coaches from Light Volleyball Association of HKG (LVBAHK). Content for this program is designed by the project co-ordinator (PC) and LVBAHK, which was found to be effective for improving health of older adults [17]. The TC Group will utilize a simplified 24-form Yang Style TC that is designed for easy learning and mastery. Participants will be led by a qualified TC instructor, and they will replicate instructors motions, postures, and movement speed. Any incorrect performance will be rectified by the instructor in the class. During the intervention, the control group participants will be instructed to maintain their normal daily activity and join regular non-exercise social gatherings in order to balance the psychosocial effect (i.e., maintain the internal validity of the study) of regular gatherings for the LVB and TC groups.  

Description for medicine or protocol of treatment in detail:

About 315 participants will be randomly assigned into LVB group, TC group and control group in 1:1:1 ratio. Data will be collected at baseline (pretest), after a 16-week intervention (posttest), and 6 months and 12 months after intervention. The intervention will be based on the previous program specifically designed for older adults in LVB [17] and in TC [18]. Each program consists of 32 training sessions, with 2 x 90-minutes sessions per week. The duration of the proposed intervention is consistent with the recommendation of U.S. Department of Health and Human Services, HHS [22]. The LVB Groups program will be delivered by registered coaches from Light Volleyball Association of HKG (LVBAHK). Content for this program is designed by the project co-ordinator (PC) and LVBAHK, which was found to be effective for improving health of older adults [17]. The TC Group will utilize a simplified 24-form Yang Style TC that is designed for easy learning and mastery. Participants will be led by a qualified TC instructor, and they will replicate instructors motions, postures, and movement speed. Any incorrect performance will be rectified by the instructor in the class. During the intervention, the control group participants will be instructed to maintain their normal daily activity and join regular non-exercise social gatherings in order to balance the psychosocial effect (i.e., maintain the internal validity of the study) of regular gatherings for the LVB and TC groups.  

研究设计:

半随机对照 

Study design:

Quasi-randomized controlled 

纳入标准:

1) 65 years old or above; 2) less than 150 mins of moderate physical activities per week; 3) absence of diagnosed cognitive impairment; 4) living in the community independently; 5) passing score on the timed-up-and-go test (TUG) and Abbreviated Mental Test (AMT). 

Inclusion criteria

1) 65 years old or above; 2) less than 150 mins of moderate physical activities per week; 3) absence of diagnosed cognitive impairment; 4) living in the community independently; 5) passing score on the timed-up-and-go test (TUG) and Abbreviated Mental Test (AMT). 

排除标准:

1. exceeds 20 seconds on the TUG; or 2. AMT score less than 6; 3. exhibit steady hypertension (160/90mmHg or above), arthritis, and neurological disorder. 

Exclusion criteria:

1. exceeds 20 seconds on the TUG; or 2. AMT score less than 6; 3. exhibit steady hypertension (160/90mmHg or above), arthritis, and neurological disorder. 

研究实施时间:

Study execute time:

From2019-06-01To 2023-06-05 

干预措施:

Interventions:

组别:

Group 1

样本量:

105

Group:

Group 1

Sample size:

干预措施:

Lightvolleyball

干预措施代码:

Intervention:

Lightvolleyball

Intervention code:

组别:

Group 2

样本量:

105

Group:

Group 2

Sample size:

干预措施:

Taichi

干预措施代码:

Intervention:

Taichi

Intervention code:

组别:

Control group

样本量:

105

Group:

Control grpup

Sample size:

干预措施:

Control

干预措施代码:

Intervention:

Control

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):

香港浸會大學 

单位级别:

Sport and Physical Education 

Institution
hospital:

Hong Kong Baptist University  

Level of the institution:

Sport and Physical Education 

测量指标:

Outcomes:

指标中文名:

functional fitness

指标类型:

主要指标 

Outcome:

functional fitness

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Balance Test

指标类型:

主要指标 

Outcome:

Balance Test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Resilience

指标类型:

主要指标 

Outcome:

Resilience

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Quality of life

指标类型:

主要指标 

Outcome:

Quality of life

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

PA enjoyment

指标类型:

主要指标 

Outcome:

PA enjoyment

Type:

Primary 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:

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 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):

Trained research assistant are responsible for generating the random number sequence. Participants are randomly allocated to the groups using the excel.

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

Trained research assistant are responsible for generating the random number sequence. Participants are randomly allocated to the groups using the excel.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

nil

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

nil

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:

nil

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

nil

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-10-17
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