ChiCTR1900025397招募中Unknown
A randomized trial on the comparative effects of ‘mindfulness of sound’ versus stretching and resistance training exercises on physio-psycho-spiritual wellbeing in people with Parkinson’s disease
University Fund3 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2019年8月26日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 3
- 主要终点
- Psychological distress
研究概览
简要总结
To examine the comparative effects of mindfulness of sound on psychological distress, motor symptoms, non-motor symptoms, mobility and gait, mindfulness attitude, and HRQOL of PD individuals, compared with stretching and resistant training exercises.
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
- •diagnosed with idiopathic PD (Hoehn and Yahr stage I-III);
- •aged >=18 years;
- •able to stand unaided and walk with or without an assistive device, and
- •able to give written consent.
排除标准
- •Individuals will be excluded if they:
- •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;
- •are currently participating in any other behavioural or pharmacological trial;
- •have cognitive impairment as indicated by the abbreviated mental test lower than 6, or
- •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
Sound Meditation
Control group
Stretching and resistance exercise
结局指标
主要结局
Psychological distress
时间窗: (i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention
次要结局
- Motor symptoms and non-motor symptoms((i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention)
- Mobility((i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention)
- Gait analysis((i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention)
- Cognition((i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention)
- Mindfulness attitude((i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention)
- Health-related quality of life((i) baseline, (ii) immediately post-intervention and (iii) 3-month post-intervention)
研究者
研究点 (3)
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