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【ChiCTR2100045939】A randomized trial on the comparative effects of 'mindfulness in stillness' versus 'mindfulness in motion' on physio-psycho-spiritual wellbeing in people with Parkinson's disease

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基本信息

登记号

ChiCTR2100045939

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2021-04-29

临床申请受理号

靶点

适应症

Parkinson's disease

试验通俗题目

A randomized trial on the comparative effects of 'mindfulness in stillness' versus 'mindfulness in motion' on physio-psycho-spiritual wellbeing in people with Parkinson's disease

试验专业题目

‘Mindfulness in stillness' or 'mindfulness in motion'? A randomized controlled trial on the effects and acceptability of individual mindfulness techniques – meditation and yoga – on anxiety and depression in people with Parkinson's disease

申办单位信息

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临床试验信息

试验目的

To examine the comparative effects of mindfulness of stillness versus ‘mindfulness of motion’ on psychological distress, motor symptoms, non-motor symptoms, mobility and gait, mindfulness attitude, and HRQOL of PD individuals, compared with usual care control.

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

All eligible participants will be assigned with a sequential participant number. A computer-generated randomization sequence will be generated, participants will be assigned to either one of the three groups by an independent research assistant.

盲法

All outcome assessors will be blinded to subject allocation.

试验项目经费来源

General Research Fund, University Grants Committee

试验范围

目标入组人数

实际入组人数

第一例入组时间

2021-05-04

试验终止时间

2022-12-31

是否属于一致性

入选标准

1. Diagnosed with idiopathic PD (Hoehn and Yahr stage I-III); 2. Aged >=18 years; 3. Able to stand unaided and walk with or without an assistive device; 4. Able to give written consent.；

排除标准

1. Have been regularly practicing instructor-led mind-body interventions such as meditation, yoga, Tai Chi, Qigong, or dance once a week or more during the past 6 months; 2. Are currently participating in any other behavioural or pharmacological trial; 3. Have cognitive impairment as indicated by the abbreviated mental test lower than 6; 4. 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

N/A

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