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【ChiCTR2500107039】Effects of a Mindfulness Karate Program on Depressive Symptoms, Physical Fitness and Quality of Life in Community-Dwelling Older Adults: A Randomized Controlled Trial

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基本信息

登记号

ChiCTR2500107039

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2025-08-01

临床申请受理号

靶点

适应症

试验通俗题目

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

试验专业题目

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

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联系人邮编

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临床试验信息

试验目的

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.

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试验类型

整群随机分组

试验分期

其它

随机化

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.

盲法

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

试验项目经费来源

试验范围

目标入组人数

实际入组人数

第一例入组时间

2025-01-06

试验终止时间

2025-03-07

是否属于一致性

入选标准

(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.；

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.；

研究者信息

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试验机构

Hong Kong Baptist University

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