MOVIN' CARE for PD: A Project on Community Awareness, Rehabilitation and Empowerment for Parkinson's Disease (Mind-body Interventions)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Change of self-compassion
研究概览
简要总结
The goal of this intervention study is to investigate the effectiveness of two mind-body interventions - yoga, and arts-based approaches in improving the psycho-social-spiritual well-being among PD patients. The hypotheses include:
H1: Yoga and arts-based interventions will significantly improve the psycho-social-spiritual well-being among PD patients H2: Yoga and arts-based interventions will significantly alleviate or maintain PD-related symptoms and severity levels H3: There is no significant difference between the effectiveness of yoga and arts-based interventions on psycho-social-spiritual well-being among PD patients
Eligible individuals will be invited to a baseline assessment followed by a randomization to the two intervention groups. A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment, to investigate the immediate and long-term effects.
详细描述
Parkinson's disease (PD), the second most common neurodegenerative disease, usually results in physical deterioration, as well as a spectrum of psychosocial sequels that could bring various challenges on one's daily lives. Patients experience common motor symptoms, including tremor, rigidity, bradykinesia, and postural instability, in parallel with psychosocial stressors (i.e., non- motor symptoms NMS), such as sleep disturbance, cognitive deficits, gastrointestinal symptoms, dopaminergic drug-induced behaviors (e.g., hallucination, impulse control issues) and mood disturbance (e.g., depression, anxiety). While 21% of individuals struggling with the disease reported at least one of these psychosocial symptoms within the initial stage of the disease, they are generally at risk for increased emotional distress, cognitive declines, and elevated stress hormone (cortisol) levels.
Both motor and non-motor symptoms of Parkinson's disease could affect the quality of life of individuals and that of their caregivers. A cross-sectional study conducted by our research team has explored the symptom burden and support care needs in people with PD across East and Southern Asia (n=186), revealing significant unmet needs among Hong Kong PD patients regarding their psychosocial-spiritual concerns. In particular, they experience significant, moderate palliative care needs at the early to middle course of the illness. The extent of unmet support care needs among patients with mild to moderate PD is as great as that among patients with other chronic health conditions, such as advanced cancer, late-stage lung cancer, stage 4/5 chronic obstructive pulmonary disease and late stage chronic kidney disease. The visible and unpredictable symptoms of a distorted body (e.g., tremor and gait dysfunction) and the suppressed expressions due to having a masked face, reduced voice and slurred speech often results in difficulty seeking help and stigmatization of the disease.
Despite the tremendous influences and common occurrence of NMS, they are surprisingly under- recognized in clinical practice because of the lack of spontaneous verbal complaints by the patients, as well as the lack of systematic questioning by healthcare professionals. A qualitative exploration of the illness experience of local PD patients highlighted the importance and urgent need for holistic PD interventions that emphasizes on early identification and preventive measures of individual who are at risk for PD patients, alleviation of the effects of the psychological sequels to PD patients, as well as the reduction of stigma and promotion of community support towards PD.
The study adopts a 2-arm randomized controlled design, aiming to investigate the effectiveness of two mind-body interventions - yoga, and arts-based approaches in improving the psycho-social-spiritual well-being among PD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Due to the nature of this trial, neither the staff, participants nor care provider can be masked to allocation. The data analyst will be blinded after study completion by having the intervention group information coded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults who are diagnosed with idiopathic, mild-to-advance PD as indicated by Hoehn and Yahr Scale (19) Stage I to IV (those with unilateral/bilateral symptoms, with/without postural instability who are able to walk at least 3 meters or stand unassisted);
- •aged 18 or above;
- •able to give written informed consent;
- •able to access to the internet and smartphone/ tablet/ laptop will be included; and
- •able to comprehend Chinese will be included.
排除标准
- •participants have significant cognitive impairment as indicated by the Abbreviated Mental Test lower than 6 significant
- •participants have been regularly engaged in regular instructor-led mind-body exercise (e.g., Taichi) or arts-based therapies (>2 times per week) in the past 3 months
- •currently participating in any other behavioral or pharmacological trial
- •participants have other contraindication(s) that may limit their full participation (e.g. severe hearing or vision impairment, etc.).
结局指标
主要结局
Change of self-compassion
时间窗: A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment
Self-compassion will be measured by the 12-items Self-compassion Scale(SCS). Using a five-points Likert scale, it explores the six dimensions of self-compassion: self- kindness, self-judgment, common humanity, isolation, mindfulness, and over-identified. The total score ranges from 0-60 and will be computed into a mean score (range from 1-5) for analysis. High capacity for self-compassion is reflected by a high score. Cronbach's α is 0.64 for the Chinese version.
Change of Perceived stress level
时间窗: A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment
Perceived Stress Scale (PSS) uses a five-point Likert scale to measure the perceived stress level. The 10 items in the scale can be divided into two subscales, measuring the perceived helplessness, and inadequacy of self-efficacy. The scale ranges from 0-40, with a high score indicates a high perceived stress level. The Cronbach's α of the validated Chinese version of the scale is 0.85.
Change of PD-related symptoms
时间窗: A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment
PD-related symptoms will be measured by the validated Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS- UPDRS)(Chinese) Part I to IV \[13\]. The four dimensions measured by the scale include (i) non-motor experiences of daily living, (ii) motor experiences of daily living, (iii) severity of motor symptoms, and (iv) motor complications. High scores indicate great disease severity. Cronbach's α are 0.79-0.94. In addition, Mon4t (by Montfort Brain Monitor, Tel-Aviv, Israel) is a mobile application that evaluates PD-related motor symptoms of participants. It is commonly used for tasks including timed-up-and-go, finger tapping, measuring resting tremor and postural tremor.
Change of overall Quality of Life assessed by the WHOQOL-BREF
时间窗: A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment
Overall quality of life will be measured by the WHOQOL-BREF. It will measure the four dimensions of quality of life, including physical health, psychological health, social relationships, and environment. The scale consists of 26 items and uses a five-point Likert scale. The higher the score, the better the quality of life. The Cronbach's α of the subscales ranges from 0.73-0.82.
Change of Quality of Life specified to Parkinson's Disease assessed by the PDQ-8
时间窗: A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment
The validated Chinese version of Parkinson's Disease Questionnaire-8 consists of 8-items and it captures PD-related health-related quality of life (HRQOL) in eight domains, including mobility, activities of daily living, emotional wellbeing, social support, communication, cognition, body discomfort and stigma. A high score indicates worse HRQOL. Cronbach's α is 0.80.
次要结局
- Change of self-efficacy assessed by SEMCD(A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment)
- Change of Constipation severity(A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment)
- Change of Gut microbiota composition(A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment)
- User's satisfaction(3-month (T1))
- Change of Bowel habits(A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment)
- Change of perceived social support(A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment)