Clinical trial NCT06452043: Nature-based Therapy Program for Parkinson's Disease (PARC)
Official title: Nature-based Therapy Program for Sustainable Health in Parkinson's Disease (PARC Project) - a Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Fall Patients
Aging Problems
Parkinson Disease
Keywords: Aging
Rehabilitation
Postural control
Falls
Biomechanics
Well-being
Social
Mobility
Strength
Nature-based therapy
Shinrin-Yoku
Forest bathing
Mindfulness
Meditation
Physical activity
Lead sponsor: Université du Québec à Chicoutimi
Sponsor class: OTHER
Collaborators: name: Réseau Parkinson Québec
name: McGill University
name: Fonds de la Recherche en Santé du Québec
First posted: 2024-06-11
Enrollment: 11
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical trial design
Primary purpose: TREATMENT

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.

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:

* 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.

Primary outcomes:
measure: Postural control
timeFrame: change from baseline at 0 to 8 weeks
measure: Walking
timeFrame: change from baseline at 0 to 8 weeks
measure: Well-being state (WHO-5)
timeFrame: change from baseline at 0 to 8 weeks
measure: Depression state (PHQ-9)
timeFrame: change from baseline at 0 to 8 weeks
measure: Social Provisions (SPS-10)
timeFrame: change from baseline at 0 to 8 weeks
measure: Connection to nature (CNS)
timeFrame: change from baseline at 0 to 8 weeks
Secondary outcomes:
measure: Functional mobility test (TUG)
timeFrame: change from baseline at 0 to 8 weeks
measure: 5 times Sit-To-Stand (FTSTS)
timeFrame: change from baseline at 0 to 8 weeks
measure: Maximal isometric hand grip strength
timeFrame: change from baseline at 0 to 8 weeks
measure: Number of falls
timeFrame: change from baseline at 0 to 8 weeks
measure: Trunk postural control on wobble chair
timeFrame: change from baseline at 0 to 8 weeks
Other outcomes:
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: change from baseline at 0 to 8 weeks
measure: Frailty criteria from Fried
timeFrame: change from baseline at 0 to 8 weeks
measure: Hoehn and Yahr Scale
timeFrame: Only at baseline from Sample characterization when Parkinson was included
measure: Cognitive status
timeFrame: Only at baseline from Sample characterization
Locations:
city: Saguenay
country: Canada
facility: Rubens da Silva
state: Quebec
Study officials:
affiliation: Université du Québec à Chicoutimi
name: Rubens da Silva, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université du Québec à Chicoutimi
name: Marie-Ève Langelier, MD
role: STUDY_CHAIR
affiliation: Université du Québec à Chicoutimi
name: Émilie Fortin, PT
role: STUDY_CHAIR
affiliation: Université du Québec à Chicoutimi
name: Mireille Cliche, SW
role: STUDY_CHAIR
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