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

NCT06452043 | Completed

• 1 other identifier: 2024-1664
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• Postural control

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

  change from baseline at 0 to 8 weeks

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Functional mobility test (TUG)

  change from baseline at 0 to 8 weeks

• 5 times Sit-To-Stand (FTSTS)

  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

• Trunk postural control on wobble chair

  change from baseline at 0 to 8 weeks

Other Outcomes (4)

• Falls Efficacy Scale-International (FES-I)

  change from baseline at 0 to 8 weeks

• Frailty criteria from Fried

  change from baseline at 0 to 8 weeks

• Hoehn and Yahr Scale

  Only at baseline from Sample characterization when Parkinson was included

Study Arms (1)

Nature-based intervention

EXPERIMENTAL

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

Other: PARC program

Interventions

PARC program OTHER

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

Also known as: Nature-based therapy

Nature-based intervention

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université du Québec à Chicoutimi: lead
• Réseau Parkinson Québec: collaborator
• McGill University: collaborator
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

Rubens da Silva

Saguenay, Quebec, G7H 2B1, Canada

Location

Related Publications (12)

• 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.

  PMID: 26493731 BACKGROUND

• 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.

  PMID: 31733705 BACKGROUND

• 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.

  PMID: 28335541 BACKGROUND

• 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.

  PMID: 28796634 BACKGROUND

• 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. doi: 10.1007/s00415-022-11091-1. Epub 2022 Apr 5.

  PMID: 35378605 BACKGROUND

• 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.

  PMID: 25797882 BACKGROUND

• 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.

  PMID: 26927141 BACKGROUND

• 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.

  PMID: 7495224 BACKGROUND

• 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.

  PMID: 30544682 BACKGROUND

• 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.

  PMID: 38215954 BACKGROUND

• 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.

  PMID: 11253156 BACKGROUND

• 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.

  PMID: 30118638 BACKGROUND

MeSH Terms

Conditions

Chronic Disease; Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Rubens da Silva, PhD

  Université du Québec à Chicoutimi

  PRINCIPAL INVESTIGATOR

• Marie-Ève Langelier, MD

  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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and professor

Model Details: Clinical trial design

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 11, 2024
• Study Start: August 5, 2024
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)