ChiCTR2500107039 版本V1.0 版本创建时间2025/08/01 17:38:07 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500107039 

最近更新日期：

Date of Last Refreshed on：

 2025-08-01 17:37:44 

注册时间：

Date of Registration：

 2025-08-01 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Effects of a Mindfulness Karate Program on Depressive Symptoms, Physical Fitness and Quality of Life in Community-Dwelling Older Adults: A Randomized Controlled Trial

Public title：

Effects of a Mindfulness Karate Program on Depressive Symptoms, Physical Fitness and Quality of Life in Community-Dwelling Older Adults: 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 Mindfulness Karate Program on Depressive Symptoms, Physical Fitness and Quality of Life in Community-Dwelling Older Adults: A Randomized Controlled Trial

Scientific title：

Effects of a Mindfulness Karate Program on Depressive Symptoms, Physical Fitness and Quality of Life in Community-Dwelling Older Adults: 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：

DUAN Yan Ping 

研究负责人：

CHEUNG Chun Hei 

Applicant：

DUAN Yan Ping 

Study leader：

CHEUNG Chun Hei 

申请注册联系人电话：

Applicant telephone：

 +852 3411 5638

研究负责人电话：

Study leader's
telephone：

+852 9090 5483

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：

 duanyp@hkbu.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 21211876@life.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：

AAB 933, Department of Sports and Health Sciences, Hong Kong Baptist University, Kowloon Tong, Hong Kong SAR, China

研究负责人通讯地址：

AAB 933, Department of Sports and Health Sciences, Hong Kong Baptist University, Kowloon Tong, Hong Kong SAR, China

Applicant address：

AAB 933, Department of Sports and Health Sciences, Hong Kong Baptist University, Kowloon Tong, Hong Kong SAR, China

Study leader's address：

AAB 933, Department of Sports and Health Sciences, Hong Kong Baptist University, Kowloon Tong, Hong Kong SAR, 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：

Hong Kong Baptist University

Applicant's institution：

Hong Kong Baptist University

研究负责人所在单位：

Hong Kong Baptist University

Affiliation of the Leader：

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：

 FASS-SPEH-2024-25_004

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：

Hong Kong Baptist University Research Ethics Committee

Name of the ethic committee：

Hong Kong Baptist University Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-12-20 00:00:00

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 Office, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, China

Contact Address of the ethic committee：

Research Office, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3411 2623

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 hkbu_rec@hkbu.edu.hk

研究实施负责（组长）单位：

Hong Kong Baptist University

Primary sponsor：

Hong Kong Baptist University

研究实施负责（组长）单位地址：

Hong Kong Baptist University Kowloon Tong Kowloon, Hong Kong SAR, China

Primary sponsor's address：

Hong Kong Baptist University Kowloon Tong Kowloon, Hong Kong SAR, 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 SAR

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

Hong Kong Baptist University

具体地址：

Hong Kong Baptist University Kowloon Tong Kowloon, Hong Kong SAR, China

Institution
hospital：

Hong Kong Baptist University

Address：

Hong Kong Baptist University Kowloon Tong Kowloon, Hong Kong SAR, China

经费或物资来源：

Source(s) of funding：

No funding

研究疾病：

 

Target disease：

older adults with depressive symptoms

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：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

To explore the effects of an 8-week Mindfulness Karate program on depressive symptoms, physical fitness and quality of life of older adults in the community with mild to severe depressive symptoms.  

Objectives of Study：

To explore the effects of an 8-week Mindfulness Karate program on depressive symptoms, physical fitness and quality of life of older adults in the community with mild to severe depressive symptoms.

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) Age between 60 and 74 years at the commencement of the project. (2) A score on the Chinese version of the Geriatric Depression Scale (GDS-15) ranging from 5 to 15, indicating a mild to high level of depressive symptoms. (3) Successful completion of the PAR-Q+ screening or approval from a physician confirming readiness to engage in high-intensity exercise. (4) Absence of serious chronic conditions, including but not limited to coronary heart disease, chronic heart failure, chronic obstructive pulmonary disease, and osteoarthritis.

Inclusion criteria

(1) Age between 60 and 74 years at the commencement of the project. (2) A score on the Chinese version of the Geriatric Depression Scale (GDS-15) ranging from 5 to 15, indicating a mild to high level of depressive symptoms. (3) Successful completion of the PAR-Q+ screening or approval from a physician confirming readiness to engage in high-intensity exercise. (4) Absence of serious chronic conditions, including but not limited to coronary heart disease, chronic heart failure, chronic obstructive pulmonary disease, and osteoarthritis.

排除标准：

(1) Non-community-dwelling status: Older adults residing in institutionalized settings (e.g., nursing homes, hospitals, or long-term care facilities), as the study focuses on independent community dwellers who can access elderly centers. (2) Significant prior experience in relevant practices: Participants with substantial previous training or regular practice in karate, other martial arts, or formal mindfulness-based programs (e.g., MBSR), as this could confound the intervention effects. (3) ?Inability to provide informed consent: Individuals unable to understand the study procedures, risks, and benefits, or those lacking legal capacity to consent (e.g., due to guardianship or severe cognitive/psychological conditions). (4) Language or communication barriers: Inability to communicate effectively in Cantonese or read/write Chinese, as the study assessments (e.g., questionnaires) and intervention are conducted in these languages. (5) Cognitive impairment as evidenced by a score below 24 on the Chinese version of the Mini-Mental Status Examination.

Exclusion criteria：

(1) Non-community-dwelling status: Older adults residing in institutionalized settings (e.g., nursing homes, hospitals, or long-term care facilities), as the study focuses on independent community dwellers who can access elderly centers. (2) Significant prior experience in relevant practices: Participants with substantial previous training or regular practice in karate, other martial arts, or formal mindfulness-based programs (e.g., MBSR), as this could confound the intervention effects. (3) ?Inability to provide informed consent: Individuals unable to understand the study procedures, risks, and benefits, or those lacking legal capacity to consent (e.g., due to guardianship or severe cognitive/psychological conditions). (4) Language or communication barriers: Inability to communicate effectively in Cantonese or read/write Chinese, as the study assessments (e.g., questionnaires) and intervention are conducted in these languages. (5) Cognitive impairment as evidenced by a score below 24 on the Chinese version of the Mini-Mental Status Examination.

研究实施时间：

Study execute time：

从 From 2025-01-06 00:00:00至 To 2025-03-07 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-01-07 00:00:00 至 To 2025-01-09 00:00:00

干预措施：

Interventions：

组别：

Test Group

样本量：

 20

Group：

Test Group

Sample size：

干预措施：

The Mindfulness Karate intervention intervention will last 8 weeks and will include sessions in which mindfulness is integrated with martial arts practice. The sessions will be twice a week, covering for a total duration of 1.5 hours.

干预措施代码：

Intervention：

The Mindfulness Karate intervention intervention will last 8 weeks and will include sessions in which mindfulness is integrated with martial arts practice. The sessions will be twice a week, covering for a total duration of 1.5 hours.

Intervention code：

组别：

Control Group

样本量：

 20

Group：

Control Group

Sample size：

干预措施：

normal social activities (like regular phone calls etc.)

干预措施代码：

Intervention：

normal social activities (like regular phone calls etc.)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong SAR 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Hong Kong Christian Services Boplus 

单位级别：

 Community Health Service Center 

Institution
hospital：

Hong Kong Christian Services Boplus

Level of the institution：

Community Health Service Center

国家：

 China

省(直辖市)：

 Hong Kong SAR 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Hing Tin Wendell Memorial Church Alison Lam Elderly Centre  

单位级别：

 Community Health Service Center 

Institution
hospital：

Hing Tin Wendell Memorial Church Alison Lam Elderly Centre

Level of the institution：

Community Health Service Center

测量指标：

Outcomes：

指标中文名：

Depressive Symptoms

指标类型：

主要指标

Outcome：

Depressive Symptoms

Type：

Primary indicator

测量时间点：

pre-test and post-test

测量方法：

A Chinese version of the 15-item Geriatric Depression Scale will be used to measure depressive symptoms

Measure time point of outcome：

pre-test and post-test

Measure method：

A Chinese version of the 15-item Geriatric Depression Scale will be used to measure depressive symptoms

指标中文名：

Physical Fitness

指标类型：

次要指标

Outcome：

Physical Fitness

Type：

Secondary indicator

测量时间点：

pre-test and post-tes

测量方法：

The Senior Fitness Test manual (BMI, lower limb muscle strength through a 30-s chair stand test, upper limb muscle strength through a 30-s arm curl test, aerobic endurance through a two-min step test, lower body flexibility through a chair sit-and-reach test, upper body flexibility through a back scratch test, and mobility/dynamic balance through an 8-ft up-and-go task).

Measure time point of outcome：

pre-test and post-tes

Measure method：

The Senior Fitness Test manual (BMI, lower limb muscle strength through a 30-s chair stand test, upper limb muscle strength through a 30-s arm curl test, aerobic endurance through a two-min step test, lower body flexibility through a chair sit-and-reach test, upper body flexibility through a back scratch test, and mobility/dynamic balance through an 8-ft up-and-go task).

指标中文名：

Quality of Life

指标类型：

次要指标

Outcome：

Quality of Life

Type：

Secondary indicator

测量时间点：

pre-test and post-test

测量方法：

Measure time point of outcome：

pre-test and post-test

Measure method：

Hong Kong Chinese WHO Quality of Life Scale Brief Version (WHOQOL-BREF)

指标中文名：

socio-demographic data

指标类型：

附加指标

Outcome：

socio-demographic data

Type：

Additional indicator

测量时间点：

pre-test

测量方法：

gender, age, marital status, occupation, educational attainment, housing type, family size, and household income

Measure time point of outcome：

pre-test

Measure method：

gender, age, marital status, occupation, educational attainment, housing type, family size, and household income

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

No

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 62 岁 years
最大 Max age 70 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）：

The intervention will take place at elderly centers in Hong Kong, which will serve as the units for randomization. Two centers will be randomly selected and equally divided into two groups: one participating in mindfulness karate and the other in a non-mindfulness karate control group. The randomization process will utilize Excel's random function, conducted by a researcher who is not involved in participant recruitment or data collection.

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

The intervention will take place at elderly centers in Hong Kong, which will serve as the units for randomization. Two centers will be randomly selected and equally divided into two groups: one participating in mindfulness karate and the other in a non-mindfulness karate control group. The randomization process will utilize Excel's random function, conducted by a researcher who is not involved in participant recruitment or data collection.

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-blinded, outcome assessors will remain unaware of the group assignments related to the intervention.

Blinding：

single-blinded, outcome assessors will remain unaware of the group assignments related to the intervention.

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

是Yes

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）：

Individual participant data (IPD) collected in this study will be available after completion of the main analysis and publication, upon reasonable request from qualified researchers. Researchers should submit a formal data-sharing request to the first author or corresponding author via email, clearly stating the research purpose, intended use of data, and data security measures. After approval by the research team, de-identified data will be provided electronically.

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

Individual participant data (IPD) collected in this study will be available after completion of the main analysis and publication, upon reasonable request from qualified researchers. Researchers should submit a formal data-sharing request to the first author or corresponding author via email, clearly stating the research purpose, intended use of data, and data security measures. After approval by the research team, de-identified data will be provided electronically.

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：

This study will use standardized and structured Case Report Forms (CRFs) and an Electronic Data Capture (EDC) system for data collection and management. Paper-based CRFs were designed by the research team and reviewed by experts. These CRFs include demographic information, assessment results, intervention records, and adverse event reporting. All data collected on paper-based CRFs will be double-checked and transferred promptly into an electronic database to ensure accuracy and completeness.

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

This study will use standardized and structured Case Report Forms (CRFs) and an Electronic Data Capture (EDC) system for data collection and management. Paper-based CRFs were designed by the research team and reviewed by experts. These CRFs include demographic information, assessment results, intervention records, and adverse event reporting. All data collected on paper-based CRFs will be double-checked and transferred promptly into an electronic database to ensure accuracy and completeness.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-08-01 17:37:44