- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06452043
Programa de terapia basada en la naturaleza para la enfermedad de Parkinson (PARC) (PARC)
Nature-based Therapy Program for Sustainable Health in Parkinson's Disease (PARC Project) - A Clinical Trial
The goal of this clinical trial is first to determine the feasibility and 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 for this purpose are:
Will the program improve:
- The physical outcomes such as mobility, strength and balance?
- The psychosocial health outcomes?
Participants will participate in one session per week of the intervention and be assessed before and after the program. First, the adherence will be measured as the proportion of supervised outdoor sessions completed. Dropout rate will correspond to participants who will not finish the 8-week protocol, including pre- and post-intervention assessments. Satisfaction will be evaluated with a post-intervention questionnaire rating the exercise component, nature-based activities, and the PARC program on a 4-point Likert scale (0-3), capturing clarity, usefulness, difficulty, and acceptability. Adverse effects will be documented throughout the intervention. Qualitative benefits such as increased hope and improved social interaction will be collected after sessions.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 feasibility and the effects of an 8-week nature-based intervention program on the physical and mental health of individuals with PD. The feasibility indicators are:
Adherence - proportion of supervised outdoor sessions that will be completed by participants; Dropout Rate - proportion of participants who will not complete the full 8-week protocol, including pre- and post-intervention assessments; Satisfaction - participant satisfaction will be measured with a brief post-intervention questionnaire using a 4-point Likert scale assessing clarity, usefulness, difficulty, and acceptability of the NBI/PARC program; Adverse Effects - any adverse events will be documented throughout the intervention; and Perceived Benefits - qualitative feedback will be collected on perceived benefits such as increased hope and improved social interaction. In addition, 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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Quebec
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Saguenay, Quebec, Canadá, G7H 2B1
- Rubens da Silva
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Nature-based intervention
Nature-based group intervention of once a week for 8 weeks |
Activities in nature such as walking, exercises (strengthening, mobility, balance), pedal boat, yoga, dance, mindfulness, meditation, forest bathing or Shinrin-Yoku, interpretation of nature
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Depression state (PHQ-9)
Periodo de tiempo: 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
|
|
Retention rate
Periodo de tiempo: 8 weeks
|
roportion of participants completing the full 8-week protocol including pre- and post-intervention assessments. |
8 weeks
|
|
Adherence to supervised outdoor sessions
Periodo de tiempo: 8 weeks
|
Proportion of scheduled supervised outdoor sessions completed by each participant. |
8 weeks
|
|
Dropout rate
Periodo de tiempo: 8 weeks
|
Proportion of participants who discontinue participation before completing the protocol. |
8 weeks
|
|
Participant satisfaction
Periodo de tiempo: Post-intervention
|
Participant Satisfaction was measured using the "Participant Satisfaction Likert Scale", a 4-point scale ranging from 0 (strongly disagree) to 3 (strongly agree). Higher scores indicate greater satisfaction with the intervention, including clarity of instructions, perceived usefulness, exercise difficulty, and overall acceptability. |
Post-intervention
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|
Adverse effects
Periodo de tiempo: 8 weeks
|
Number and type of adverse events reported during the intervention. |
8 weeks
|
|
Qualitative feedback on perceived benefits
Periodo de tiempo: through study completion, an average of 8 weeks.
|
Qualitative feedback collected after each session through brief open-ended questions documenting perceived benefits such as increased hope, enhanced social interaction, and other emergent themes. |
through study completion, an average of 8 weeks.
|
|
Well-being state (WHO-5)
Periodo de tiempo: 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
|
|
Social Provisions (SPS-10)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional mobility test (TUG)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Postural control
Periodo de tiempo: 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 pattern
Periodo de tiempo: change from baseline at 0 to 8 weeks
|
Gait parameters from GaitRite system (14-ft walkway) measurement across two speeds: preferred and fast, with a sampling frequency of 100 Hz. |
change from baseline at 0 to 8 weeks
|
|
10 m walk test
Periodo de tiempo: change from baseline at 0 to 8 weeks
|
The test was performed along a 14 m walkway, with timing initiated at the 2 m mark and stopped at the 12 m mark to ensure steady state walking. Each participant completed two trials at both comfortable (preferred) and maximal walking (fast) speeds, and the best time for each condition was retained for analysis. |
change from baseline at 0 to 8 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Modified Falls Efficacy Scale (M FES)
Periodo de tiempo: change from baseline at 0 to 8 weeks
|
The confidence in performing daily activities without falling was evaluated using the French version of the Modified Falls Efficacy Scale (M FES), consisting of 14 items rated from 0 (no confidence) to 10 (complete confidence), with higher scores indicating greater falls related self efficacy. |
change from baseline at 0 to 8 weeks
|
|
Frailty criteria from Fried (inclusion criterium only)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Cognitive status
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Marie-Ève Langelier, MD, Université du Québec à Chicoutimi
- Investigador principal: Rubens da Silva, PhD, Université du Québec à Chicoutimi
- Silla de estudio: Émilie Fortin, PT, Université du Québec à Chicoutimi
- Silla de estudio: Mireille Cliche, SW, Université du Québec à Chicoutimi
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Sinucleinopatías
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Procesos Patológicos
- Atributos de la enfermedad
- Enfermedades neurodegenerativas
- Trastornos del movimiento
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Enfermedad de Parkinson
- Enfermedad crónica
- Actividad del motor
Otros números de identificación del estudio
- 2024-1664
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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