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
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 3
- 主要终点
- Functional balance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- Single
入排标准
- 年龄范围
- 18 至 100（—）
- 性别
- All
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.).
研究组 & 干预措施
Experimental group
Live streaming Mindfulness Yoga - Practice Awareness through Cognitive-based Exercise (MY-PACE) via Zoom
Control group
Usual care
结局指标
主要结局
Functional balance
时间窗: (i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention
Perceived balance confidence
时间窗: (i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention
次要结局
- Gait((i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention)
- PD-related motor symptoms((i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention)
- Anxiety and depressive symptoms((i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention)
- Cognitive function and attention((i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention)
- Mindfulness((i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention)
- HRQOL((i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention)
- Incidence, reason and consequence of fall((i) baseline, (ii) 1-week post-intervention, (iii) 3-month, (iv) 6-month post-intervention and (v) 12-month post-intervention)