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【ChiCTR2000033777】Effects of a live streaming Mindfulness Yoga - Practice Awareness through Cognitive-based Exercise (MY-PACE) Program on balance and gait for People with Parkinson’s Disease: A Randomised Controlled Trial

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基本信息

登记号

ChiCTR2000033777

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

2020-06-12

临床申请受理号

靶点

适应症

Parkinson's disease

试验通俗题目

Effects of a live streaming Mindfulness Yoga - Practice Awareness through Cognitive-based Exercise (MY-PACE) Program on balance and gait for People with Parkinson’s Disease: A Randomised Controlled Trial

试验专业题目

申办单位信息

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申请人名称

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联系人邮箱

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联系人邮编

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临床试验信息

试验目的

To examine the comparative effects between Mindfulness Yoga – Practice Awareness through Cognitive-based Exercise (MY-PACE) and usual care service only for Chinese patients with mild-to-moderate PD, on the following physio-psycho-cognitive outcomes: a)functional mobility (primary outcome), b)perceived balance confidence (primary outcome), c)gait, d)PD-related motor symptoms, e)anxiety and depressive symptoms, f)mindfulness, g)cognitive function, and, h)HRQOL.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Eligible participants will be randomly assigned into one of the following conditions on 1:1 basis using a randomization table produced using computer-assisted random number generator.

盲法

Single-blinded

试验项目经费来源

University Fund

试验范围

目标入组人数

实际入组人数

第一例入组时间

2020-06-22

试验终止时间

2022-09-30

是否属于一致性

入选标准

To be eligible for inclusion, individuals must be (1) diagnosed with idiopathic PD (Hoehn and Yahr stage I-III); (2) aged >=18 years; (3) able to walk with or without an assistive device; (4) able to give written consent, and (5) have access to smartphone/ tablet device and Internet connection.；

排除标准

Individuals will be excluded if they: (1) are currently participating in any other behavioural or pharmacological trial; (2) have significant cognitive impairment as indicated by the Hong Kong Montreal Cognitive Assessment 5-min protocol (HK-MoCA), cutoff scores based on the age and education corrected normative data will be used [11] [12], or (3) have serious medical conditions except PD, or other contraindication to mild-to-moderate physical exertion that might limit their full participation (e.g. severe hearing or vision impairment, significant orthopaedic problems, etc.).；

研究者信息

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试验机构

香港大學李嘉誠醫學院護理學院

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