Nature-based Therapy Program for Sustainable Health in Parkinson's Disease (PARC Project) - a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Postural control
研究概览
简要总结
The goal of this clinical trial is to learn if a nature-based program has positive effects on the physical and psychosocial health in a group of participants with Parkinson's disease. The main questions it aims to answer are:
Will the program improve:
- The physical outcomes such as mobility, strength and balance?
- The psychosocial health outcomes?
Participants will:
- Be assessed before and after the program;
- Participate in one session per week of the intervention.
详细描述
The chronic and neurodegenerative disease of Parkinson's (PD) is often characterized by movement and balance disorders, which are accompanied by an increased risk of falls. Falls are one of the most common problems that can lead to subsequent injuries (e.g., femoral head fracture) and associated mortality rates. Falls are frequent, debilitating, and have deleterious effects on self-confidence and the quality of life of individuals with PD. Additionally, according to Parkinson Canada, a high proportion of individuals living with this disease suffer from depression and/or anxiety. Therefore, it is essential to implement intervention programs aimed at improving the physical and functional capacity as well as the well-being of this population to prevent falls and promote sustainable health.
In recent years, an increasing number of studies have demonstrated the benefits of contact with nature on the physical and mental health of individuals. Specific and positive effects on psychological symptoms (e.g., depression) as well as cognition (memory) in adults have also been shown according to this recent evidence. This stimulates our research team to test the effects of a physical intervention in nature on the physical and mental health of individuals suffering from PD. One of the perspectives of this new intervention in nature is also to evaluate its impact on fall risks in this population. The ultimate goal of this project is to contribute to the sustainable health of the population.
The overall objective of this project, based on a pilot study, is to assess the effects of an 8-week nature-based intervention program on the physical and mental health of individuals with PD. Various physical measures (mobility, strength, and balance) and mental measures (level of depression, stress) will be studied in this project to better understand the effects of this type of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with Parkinson's disease (while medicated: ON);
- •capable of walking independently;
- •presenting mild to moderate disability symptoms according to the Hoehn and Yahr scale (stages 1-3);
- •having a frailty score of less than 2/5 (Fried);
- •having a cognitive status ≥26 based on the Mini-Mental State Examination (MMSE) questionnaire.
排除标准
- •Red flags (infection, tumor, etc.);
- •Severe psychiatric disorders;
- •Palliative care;
- •Severe systemic syndromes or diseases that may prevent tests and exercises from being performed;
- •Stroke - very acute phase (1 week) and this until medial hemodynamic stability.
结局指标
主要结局
Postural control
时间窗: change from baseline at 0 to 8 weeks
Measures of center of pressure (COP) from plateform of force during different balance tasks
Walking
时间窗: change from baseline at 0 to 8 weeks
Gait parameters from GaitRite measurement The participants will be asked to walk at normal and fast speeds on a GaitRite treadmill (GAI-TRite® Platinum) Plus System 16' - 4.876 m, SN: Q209, CIR Systems Inc., Franklin, NJ, USA). Participants will perform each task twice. Main gait parameters will be used as main outcomes such as velocity in m/s.
Social Provisions (SPS-10)
时间窗: change from baseline at 0 to 8 weeks
The Social Provisions Scale-10 (SPS-10) is a shorter version of the original Social Provisions Scale (SPS). It is a brief self-report questionnaire designed to measure perceived social support across five dimensions. The SPS-10 is derived from the longer SPS but consists of a subset of items that capture key aspects of social support. Similar to the original SPS, respondents rate their agreement with each item on a Likert scale, ranging from 1 (strongly disagree) to 4 (strongly agree). The SPS-10 provides a quick and efficient way to assess an individual's perceived social support network and their satisfaction with various aspects of their social relationships.
Depression state (PHQ-9)
时间窗: change from baseline at 0 to 8 weeks
The Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool used to screen, diagnose, monitor, and measure the severity of depression. It consists of nine questions based on the diagnostic criteria for major depressive disorder in the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition).Respondents rate how often they have experienced each symptom over the past two weeks on a scale ranging from 0 (not at all) to 3 (nearly every day). The scores are then added together to produce a total score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms
Well-being state (WHO-5)
时间窗: change from baseline at 0 to 8 weeks
The World Health Organization Well-Being Index (WHO-5) is a widely used self-reported questionnaire designed to measure subjective well-being. It assesses the individual's overall psychological well-being and quality of life. The WHO-5 consists of five simple questions that ask respondents to rate their well-being over the past two weeks. The questions cover aspects such as positive mood, vitality, and general interest in life. The questionnaire is scored on a scale from 0 to 100, with higher scores indicating better well-being.
Connection to nature (CNS)
时间窗: change from baseline at 0 to 8 weeks
The Connection to Nature Scale (CNS) is a psychological assessment tool designed to measure an individual's subjective connection to nature. It evaluates the degree to which people perceive themselves as a part of the natural world and the extent to which they appreciate and value nature in their lives. Respondents are asked to rate their agreement with each statement on a Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). The scores are then totaled to provide an overall measure of an individual's connection to nature.
次要结局
- 5 times Sit-To-Stand (FTSTS)(change from baseline at 0 to 8 weeks)
- Trunk postural control on wobble chair(change from baseline at 0 to 8 weeks)
- Maximal isometric hand grip strength(change from baseline at 0 to 8 weeks)
- Number of falls(change from baseline at 0 to 8 weeks)
- Functional mobility test (TUG)(change from baseline at 0 to 8 weeks)
研究者
Rubens da Silva
Director and professor
Université du Québec à Chicoutimi