ChiCTR2200065417尚未招募Unknown
A home-based dyadic mindfulness yoga programme for patients with moderate-advanced Parkinson’s disease and their family caregivers: a feasibility trial
Seed Fund for Basic Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年11月1日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Depression (dyadic outcome)
研究概览
简要总结
- To examine the feasibility and preliminary effects of a dyadic mindfulness yoga programme compared with usual care on the primary outcome (depression) and secondary outcomes (anxiety, social support, mindfulness, functional balance, HRQOL, caregiver burden and PD-related motor and non-motor symptoms) among PwPD and caregivers at one week post-intervention (T1) and three month post-intervention.
- To explore the experiences of Chinese PwPD and their family caregivers in using the dyadic mindfulness techniques for illness coping using a qualitative research approach.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- All outcome assessors will be blinded to subject allocation.
入排标准
- 年龄范围
- 50 至 80（—）
- 性别
- All
入选标准
- •We will recruit Chinese patients with idiopathic moderate-advanced PD (as indicated by the Hoehn and Yahr Scale stages III-IV: those with unilateral/bilateral symptoms, with/without postural instability who are able to walk or stand unassisted) and their family caregivers. For the patient, they need to be:
- •Aged between 50-80 years;
- •Experienced at least mild depressive symptoms–as indicated by a Patient Health Questionnaire-9 (PHQ-9) score >= 5 (15)–to ensure they are exposed to the core problem addressed by this study. As for the caregivers, they need to be self-identified as the primary co-residing caregivers of the patient counterparts for at least three months. Both of them need to be able to communicate in Cantonese. They will only be eligible if both the patient and caregiver in a dyad provide written consent to participate.
排除标准
- •Have been engaged in regular systematic mind-body practices such as Tai Chi, qigong, yoga or other forms of mindfulness training (> 2 times per week) in the past 3 months;
- •Have pre-existing acute psychotic disease;
- •Are currently participating in any other behavioural or pharmacological trial;
- •Have significant cognitive impairment as indicated by the Abbreviated Mental Test score <= 6;
- •Have other contraindication(s) that may limit their full participation (e.g., severe hearing or vision impairment, etc.).
研究组 & 干预措施
1
Yoga intervention
2
Usual control
结局指标
主要结局
Depression (dyadic outcome)
次要结局
- Anxiety (dyadic outcome)
- Social support (dyadic outcome)
- Mindfulness (dyadic outcome)
- HRQOL (dyadic outcome)
- PD-related motor and non-motor symptoms (care-recipient outcome)
- Caregiving burden (caregiver outcome)
研究者
研究点 (1)
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