AzTrials
AzTrials

Chronic DiseasePARCNCT06452043

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

A study testing PARC program in people with Chronic Disease and Fall Patients, run by Université du Québec à Chicoutimi at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 45 to 85 years
Conditions the study is for
Chronic Disease, Fall Patients, Aging Problems
What is being tested?
PARC program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteCanada
Study dates
5 Aug 2024to 7 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Rubens da Silva

    Saguenay, Quebec, G7H 2B1

Other trials in Canada

About this study

Official title: 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.
Read the 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.

Being tested
PARC program
Keywords
Aging, Rehabilitation, Postural control, Falls, Biomechanics, Well-being, Social, Mobility, Strength, Nature-based therapy, Shinrin-Yoku, Forest bathing, Mindfulness, Meditation, Physical activity
Medical subject headings
Chronic Disease, Parkinson Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PARC programOther

    Also called Nature-based therapy

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

Study groups in NCT06452043
Study groupRoleWhat they receive
Nature-based interventionExperimentalNature-based group intervention of once a week for 8 weeks
Receives: Other: PARC program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postural control

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

    Measured: change from baseline at 0 to 8 weeks

  2. 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.

    Measured: change from baseline at 0 to 8 weeks

  3. 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.

    Measured: change from baseline at 0 to 8 weeks

  4. 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

    Measured: change from baseline at 0 to 8 weeks

  5. 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.

    Measured: change from baseline at 0 to 8 weeks

  6. 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.

    Measured: change from baseline at 0 to 8 weeks

Secondary outcomes (5)

  1. 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.

    Measured: change from baseline at 0 to 8 weeks

  2. 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.

    Measured: change from baseline at 0 to 8 weeks

  3. 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.

    Measured: change from baseline at 0 to 8 weeks

  4. Number of falls

    Self-reported falls before, during and after the study

    Measured: change from baseline at 0 to 8 weeks

  5. 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.

    Measured: change from baseline at 0 to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study start5 Aug 2024
  3. Primary completion7 Oct 2024
  4. Study completion7 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Clinical trial design
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06452043
Sponsor's protocol ID
2024-1664
Acronym
PARC
Status last verified
Dec 2024
First submitted
22 May 2024
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28796634

  • 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.

    PubMed 25797882

  • 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.

    PubMed 26927141

  • 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.

    PubMed 7495224

  • 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.

    PubMed 30544682

  • 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.

    PubMed 38215954

  • 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.

    PubMed 11253156

  • 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.

    PubMed 30118638

  • 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.

    PubMed 26493731

  • 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.

    PubMed 31733705

  • 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.

    PubMed 28335541

  • 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.

    PubMed 35378605

Questions about this trial

What is this clinical trial studying?

A study testing PARC program in people with Chronic Disease and Fall Patients, run by Université du Québec à Chicoutimi at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postural control (time frame: change from baseline at 0 to 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06452043, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in