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    【ChiCTR2100049074】The effects of an integrated mindfulness-based Tai Chi Chuan program on sleep disturbance among community-dwelling elderly people: A randomized controlled trial

    基本信息
    登记号

    ChiCTR2100049074

    试验状态

    尚未开始

    药物名称

    /

    药物类型

    /

    规范名称

    /

    首次公示信息日的期

    2021-07-20

    临床申请受理号

    /

    靶点

    /

    适应症

    Older people with sleep disturbance

    试验通俗题目

    The effects of an integrated mindfulness-based Tai Chi Chuan program on sleep disturbance among community-dwelling elderly people: A randomized controlled trial

    试验专业题目

    The effects of an integrated mindfulness-based Tai Chi Chuan program on sleep disturbance among community-dwelling elderly people: A randomized controlled trial

    申办单位信息
    申请人联系人
    申请人名称
    联系人邮箱
    联系人邮编

    联系人通讯地址
    临床试验信息
    试验目的

    1. To evaluate the effects of an integrated mindfulness-based Tai Chi Chuan (MBTCC) program on the improvement of insomnia and other secondary outcomes over a 12-month follow-up period, by comparing it to a sleep hygiene education (SHE) control group among community dwelling elderly individuals experiencing sleep disturbances. 2. To explore the mediating roles of rumination, arousal level, psychological and physical function as mechanisms underlying the beneficial effects of the MBTCC group on insomnia severity. 3. To identify and understand the therapeutic ingredients and conditions that contribute to the beneficial effects of the intervention through a qualitative evaluation.

    试验分类
    试验类型

    随机平行对照

    试验分期

    探索性研究/预试验

    随机化

    After the initial baseline assessment, participants will be randomly assigned to one of the study arms using a list of computer-generated random numbers. The generation of random numbers and their assignment will be performed by a statistician who is unaware of the study aims.

    盲法

    Not stated

    试验项目经费来源

    Health and Medical Research Fund

    试验范围

    /

    目标入组人数

    107

    实际入组人数

    /

    第一例入组时间

    2021-07-01

    试验终止时间

    2024-06-30

    是否属于一致性

    /

    入选标准

    (1) aged 60 years or above; (2) classified as experiencing sleep disturbances (indication of poor sleep quality through a score >5 in the Pittsburgh Sleep Quality Index); (3) primary education level or above and able to communicate in Cantonese; (4) able to give informed consent; (5) no previous experience with meditation or other mind-body techniques (e.g., tai chi or yoga).；

    排除标准

    People with a comorbid diagnosis of schizophrenia, schizoaffective disorder, substance misuse, organic brain syndrome, or intellectual disability will be excluded.；

    研究者信息
    研究负责人姓名
    试验机构

    The Hong Kong Polytechnic University

    研究负责人电话
    研究负责人邮箱
    研究负责人邮编

    /

    联系人通讯地址

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