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

Parkinson Disease Clinical Trial

— PARC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452043
• Other study ID #: 2024-1664
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 5, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: June 2024
• Source: Université du Québec à Chicoutimi
• Contact: Rubens da Silva, PhD
• Phone: 418 545-5011
• Email: rubens.dasilva[@]uqac.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: October 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging Problems
• Chronic Disease
• Fall Patients
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Canada	Rubens da Silva	Saguenay	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Université du Québec à Chicoutimi	Fonds de la Recherche en Santé du Québec, McGill University, Réseau Parkinson Québec

Country where clinical trial is conducted

Canada, 

References & Publications (12)

Dallaire M, Houde-Thibeault A, Bouchard-Tremblay J, Wotto EA, Cote S, Santos Oliveira C, Ngomo S, da Silva RA. Impact of frailty and sex-related differences on postural control and gait in older adults with Parkinson's Disease. Exp Gerontol. 2024 Feb;186:112360. doi: 10.1016/j.exger.2024.112360. Epub 2024 Jan 13. — View Citation

Doll R. Chronic and degenerative disease: major causes of morbidity and death. Am J Clin Nutr. 1995 Dec;62(6 Suppl):1301S-1305S. doi: 10.1093/ajcn/62.6.1301S. — View Citation

Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146. — View Citation

Frumkin H, Bratman GN, Breslow SJ, Cochran B, Kahn PH Jr, Lawler JJ, Levin PS, Tandon PS, Varanasi U, Wolf KL, Wood SA. Nature Contact and Human Health: A Research Agenda. Environ Health Perspect. 2017 Jul 31;125(7):075001. doi: 10.1289/EHP1663. — View Citation

Han JW, Choi H, Jeon YH, Yoon CH, Woo JM, Kim W. The Effects of Forest Therapy on Coping with Chronic Widespread Pain: Physiological and Psychological Differences between Participants in a Forest Therapy Program and a Control Group. Int J Environ Res Public Health. 2016 Feb 24;13(3):255. doi: 10.3390/ijerph13030255. — View Citation

Hvingelby VS, Glud AN, Sorensen JCH, Tai Y, Andersen ASM, Johnsen E, Moro E, Pavese N. Interventions to improve gait in Parkinson's disease: a systematic review of randomized controlled trials and network meta-analysis. J Neurol. 2022 Aug;269(8):4068-4079 — View Citation

Lee I, Choi H, Bang KS, Kim S, Song M, Lee B. Effects of Forest Therapy on Depressive Symptoms among Adults: A Systematic Review. Int J Environ Res Public Health. 2017 Mar 20;14(3):321. doi: 10.3390/ijerph14030321. — View Citation

Ray S, Agarwal P. Depression and Anxiety in Parkinson Disease. Clin Geriatr Med. 2020 Feb;36(1):93-104. doi: 10.1016/j.cger.2019.09.012. Epub 2019 Sep 10. — View Citation

Shen X, Wong-Yu IS, Mak MK. Effects of Exercise on Falls, Balance, and Gait Ability in Parkinson's Disease: A Meta-analysis. Neurorehabil Neural Repair. 2016 Jul;30(6):512-27. doi: 10.1177/1545968315613447. Epub 2015 Oct 21. — View Citation

Sherrington C, Tiedemann A. Physiotherapy in the prevention of falls in older people. J Physiother. 2015 Apr;61(2):54-60. doi: 10.1016/j.jphys.2015.02.011. Epub 2015 Mar 18. — View Citation

Song C, Ikei H, Park BJ, Lee J, Kagawa T, Miyazaki Y. Psychological Benefits of Walking through Forest Areas. Int J Environ Res Public Health. 2018 Dec 10;15(12):2804. doi: 10.3390/ijerph15122804. Erratum In: Int J Environ Res Public Health. 2020 Feb 18;17(4): — View Citation

Terra MB, Da Silva RA, Bueno MEB, Ferraz HB, Smaili SM. Center of pressure-based balance evaluation in individuals with Parkinson's disease: a reliability study. Physiother Theory Pract. 2020 Jul;36(7):826-833. doi: 10.1080/09593985.2018.1508261. Epub 2018 Aug 17. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Falls Efficacy Scale-International (FES-I)	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
Other	Frailty criteria from Fried	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
Other	Hoehn and Yahr Scale	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
Other	Cognitive status	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
Primary	Postural control	Measures of center of pressure (COP) from plateform of force during different balance tasks	change from baseline at 0 to 8 weeks
Primary	Walking	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
Primary	Well-being state (WHO-5)	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
Primary	Depression state (PHQ-9)	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
Primary	Social Provisions (SPS-10)	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
Primary	Connection to nature (CNS)	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	Functional mobility test (TUG)	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
Secondary	5 times Sit-To-Stand (FTSTS)	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
Secondary	Maximal isometric hand grip strength	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
Secondary	Number of falls	Self-reported falls before, during and after the study	change from baseline at 0 to 8 weeks
Secondary	Trunk postural control on wobble chair	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