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帕金森病自然疗法计划 (PARC) (PARC)

2026年11月2日 更新者:Rubens da Silva、Université du Québec à Chicoutimi

Nature-based Therapy Program for Sustainable Health in Parkinson's Disease (PARC Project) - A Clinical Trial

The goal of this clinical trial is first to determine the feasibility and 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 for this purpose are:

Will the program improve:

  • The physical outcomes such as mobility, strength and balance?
  • The psychosocial health outcomes?

Participants will participate in one session per week of the intervention and be assessed before and after the program. First, the adherence will be measured as the proportion of supervised outdoor sessions completed. Dropout rate will correspond to participants who will not finish the 8-week protocol, including pre- and post-intervention assessments. Satisfaction will be evaluated with a post-intervention questionnaire rating the exercise component, nature-based activities, and the PARC program on a 4-point Likert scale (0-3), capturing clarity, usefulness, difficulty, and acceptability. Adverse effects will be documented throughout the intervention. Qualitative benefits such as increased hope and improved social interaction will be collected after sessions.

研究概览

详细说明

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 feasibility and the effects of an 8-week nature-based intervention program on the physical and mental health of individuals with PD. The feasibility indicators are:

Adherence - proportion of supervised outdoor sessions that will be completed by participants; Dropout Rate - proportion of participants who will not complete the full 8-week protocol, including pre- and post-intervention assessments; Satisfaction - participant satisfaction will be measured with a brief post-intervention questionnaire using a 4-point Likert scale assessing clarity, usefulness, difficulty, and acceptability of the NBI/PARC program; Adverse Effects - any adverse events will be documented throughout the intervention; and Perceived Benefits - qualitative feedback will be collected on perceived benefits such as increased hope and improved social interaction. In addition, 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.

研究类型

介入性

注册 (实际的)

11

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Quebec
      • Saguenay、Quebec、加拿大、G7H 2B1
        • Rubens da Silva

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

45年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Cancer;
  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Nature-based intervention

Nature-based group intervention of once a week for 8 weeks

Activities in nature such as walking, exercises (strengthening, mobility, balance), pedal boat, yoga, dance, mindfulness, meditation, forest bathing or Shinrin-Yoku, interpretation of nature

其他名称:
  • 基于自然的疗法

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Depression state (PHQ-9)
大体时间: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

change from baseline at 0 to 8 weeks
Retention rate
大体时间:8 weeks

roportion of participants completing the full 8-week protocol including pre- and post-intervention assessments.

8 weeks
Adherence to supervised outdoor sessions
大体时间:8 weeks

Proportion of scheduled supervised outdoor sessions completed by each participant.

8 weeks
Dropout rate
大体时间:8 weeks

Proportion of participants who discontinue participation before completing the protocol.

8 weeks
Participant satisfaction
大体时间:Post-intervention

Participant Satisfaction was measured using the "Participant Satisfaction Likert Scale", a 4-point scale ranging from 0 (strongly disagree) to 3 (strongly agree). Higher scores indicate greater satisfaction with the intervention, including clarity of instructions, perceived usefulness, exercise difficulty, and overall acceptability.

Post-intervention
Adverse effects
大体时间:8 weeks

Number and type of adverse events reported during the intervention.

8 weeks
Qualitative feedback on perceived benefits
大体时间:through study completion, an average of 8 weeks.

Qualitative feedback collected after each session through brief open-ended questions documenting perceived benefits such as increased hope, enhanced social interaction, and other emergent themes.

through study completion, an average of 8 weeks.
Well-being state (WHO-5)
大体时间: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.

change from baseline at 0 to 8 weeks
Social Provisions (SPS-10)
大体时间: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.

change from baseline at 0 to 8 weeks
Connection to nature (CNS)
大体时间: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.

change from baseline at 0 to 8 weeks

次要结果测量

结果测量
措施说明
大体时间
Functional mobility test (TUG)
大体时间:change from baseline at 0 to 8 weeks

To assess mobility. Equipment: A stopwatch. Directions: Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.

change from baseline at 0 to 8 weeks
5 times Sit-To-Stand (FTSTS)
大体时间:change from baseline at 0 to 8 weeks

f the 30 second sit to stand test was not applied for some patients, we used also this test which it measures the amount of time it takes for a patient to sit and stand five times in succession with arms folded across their chest. 2 trials were applied in this test and the best time in seconds used for analysis.

change from baseline at 0 to 8 weeks
Maximal isometric hand grip strength
大体时间:change from baseline at 0 to 8 weeks

Jamar dynamometer to assess maximal isometric hand grip strength and frailty criteria. 3 trials of maximal contraction up 5 seconds. The best value was retained and corrected by body mass index from Fried classification.

change from baseline at 0 to 8 weeks
Postural control
大体时间:change from baseline at 0 to 8 weeks

Measures of center of pressure (COP) from plateform of force during different balance tasks

change from baseline at 0 to 8 weeks
Walking pattern
大体时间:change from baseline at 0 to 8 weeks

Gait parameters from GaitRite system (14-ft walkway) measurement across two speeds: preferred and fast, with a sampling frequency of 100 Hz.

change from baseline at 0 to 8 weeks
10 m walk test
大体时间:change from baseline at 0 to 8 weeks

The test was performed along a 14 m walkway, with timing initiated at the 2 m mark and stopped at the 12 m mark to ensure steady state walking. Each participant completed two trials at both comfortable (preferred) and maximal walking (fast) speeds, and the best time for each condition was retained for analysis.

change from baseline at 0 to 8 weeks

其他结果措施

结果测量
措施说明
大体时间
Modified Falls Efficacy Scale (M FES)
大体时间:change from baseline at 0 to 8 weeks

The confidence in performing daily activities without falling was evaluated using the French version of the Modified Falls Efficacy Scale (M FES), consisting of 14 items rated from 0 (no confidence) to 10 (complete confidence), with higher scores indicating greater falls related self efficacy.

change from baseline at 0 to 8 weeks
Frailty criteria from Fried (inclusion criterium only)
大体时间:change from baseline at 0 to 8 weeks

The presence of frailty criteria according to Fried was assessed with self-report questions and two physical tests from five characteristics : 1) Low physical activity (to capture history of sedentary behavior or activity: ex. Do you get any physical exercise for the sake of exercising? How often do you leave your house?); 2) fatigue (complaint of exhaustion with normal activity such as walking outside, climbing stairs: ex. I felt that everything I did was an effort in the last week?); 3) weight loss (unintentional weight loss 10 lbs. or more in past year or more than 5% in past year); 4) weakness (grip strength evaluated with manual dynamometer; in average <30 kg for men and <18 kg for women, but data is normalized by body mass index); 5) slowness or slow walking speed (usual gait speed over 4.57 meters (15 feet); ex. >6.5 seconds, dependent of height).

change from baseline at 0 to 8 weeks
Hoehn and Yahr Scale
大体时间:Only at baseline from Sample characterization when Parkinson was included

It is a five-point scale used by doctors and researchers to rate the degree of disability and severity of symptoms caused by Parkinson's disease:

Stage 1: Unilateral involvement only Stage 1.5: Unilateral and axial involvement Stage 2: Bilateral involvement without impairment of balance Stage 2.5: Mild bilateral disease with recovery on pull test Stage 3: Mild to moderate bilateral disease; some postural instability; physically independent Stage 4: Severe disability; still able to walk or stand unassisted Stage 5: Wheelchair bound or bedridden unless aided

Only at baseline from Sample characterization when Parkinson was included
Cognitive status
大体时间:Only at baseline from Sample characterization

Mini-mental state questionnaire (MMSE or Folstein), which is used for grading the cognitive state of patients in this study. It's assessing the attention and orientation, memory, registration, recall, calculation, language and ability to draw a complex polygon.

It is ranged from 0 to 30, where 30 means no impairment.

Only at baseline from Sample characterization

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Marie-Ève Langelier, MD、Université du Québec à Chicoutimi
  • 首席研究员:Rubens da Silva, PhD、Université du Québec à Chicoutimi
  • 学习椅:Émilie Fortin, PT、Université du Québec à Chicoutimi
  • 学习椅:Mireille Cliche, SW、Université du Québec à Chicoutimi

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年8月5日

初级完成 (实际的)

2024年10月7日

研究完成 (实际的)

2024年10月7日

研究注册日期

首次提交

2024年5月22日

首先提交符合 QC 标准的

2024年6月4日

首次发布 (实际的)

2024年6月11日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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