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Clinical Trials/NCT06452043
NCT06452043
Completed
Not Applicable

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

Université du Québec à Chicoutimi1 site in 1 country11 target enrollmentAugust 5, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Disease
Sponsor
Université du Québec à Chicoutimi
Enrollment
11
Locations
1
Primary Endpoint
Postural control
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 5, 2024
End Date
October 7, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rubens da Silva

Director and professor

Université du Québec à Chicoutimi

Eligibility Criteria

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

  • 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.

Outcomes

Primary Outcomes

Postural control

Time Frame: change from baseline at 0 to 8 weeks

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

Walking

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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