Nature-based Therapy Program for Parkinson's Disease (PARC) (PARC)

December 3, 2024 updated by: 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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Saguenay, Quebec, Canada, G7H 2B1
        • Rubens da Silva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nature-based intervention
Nature-based group intervention of once a week for 8 weeks
Other: PARC program
Activities in nature such as walking, exercises (strengthening, mobility, balance), pedal boat, yoga, dance, mindfulness, meditation, forest bathing or Shinrin-Yoku, interpretation of nature
Other Names:
  • Nature-based therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from baseline at 0 to 8 weeks
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.
change from baseline at 0 to 8 weeks
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.
change from baseline at 0 to 8 weeks
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
change from baseline at 0 to 8 weeks
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.
change from baseline at 0 to 8 weeks
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.
change from baseline at 0 to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional mobility test (TUG)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Number of falls
Time Frame: change from baseline at 0 to 8 weeks
Self-reported falls before, during and after the study
change from baseline at 0 to 8 weeks
Trunk postural control on wobble chair
Time Frame: change from baseline at 0 to 8 weeks
This test measures trunk postural balance during a sitting balance task on an unstable chair where only lumbar spine movements are allowed to restore balance. Briefly, the base of the chair consists of a pivot at its center and four springs that can be arranged and fixed at a distance varying between 6.0 and 21 cm from the center, allowing the system's level of stability to be varied. The system allows only forward/backward and lateral tilting.
change from baseline at 0 to 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Falls Efficacy Scale-International (FES-I)
Time Frame: change from baseline at 0 to 8 weeks
The Falls Efficacy Scale-International (FES-I) is a short, easy to administer tool that measures the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity. The level of concern is measured on a four point Likert scale (1=not at all concerned to 4=very concerned)
change from baseline at 0 to 8 weeks
Frailty criteria from Fried
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université du Québec à Chicoutimi

Collaborators

McGill University
Fonds de la Recherche en Santé du Québec
Réseau Parkinson Québec

Investigators

  • Study Chair: Marie-Ève Langelier, MD, Université du Québec à Chicoutimi
  • Principal Investigator: Rubens da Silva, PhD, Université du Québec à Chicoutimi
  • Study Chair: Émilie Fortin, PT, Université du Québec à Chicoutimi
  • Study Chair: Mireille Cliche, SW, Université du Québec à Chicoutimi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2024

Primary Completion (Actual)

October 7, 2024

Study Completion (Actual)

October 7, 2024

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-1664

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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