- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07632417
A Study on the Effects of Forest Therapy on Sarcopenia
Purpose: The goal of this study is to investigate the effects of an 8-week Forest Based Intervention program on muscle strength, physical performance, and psychological well-being in older women with sarcopenia.
Duration: The program lasts for 8 weeks, with 2 sessions per week (16 sessions total). Each session is approximately 180 minutes.
Activities: Participants will take part in a structured program at the Caoling Shibi Forest Healing Base in Yunlin. The program includes forest trail walking, resistance training using elastic bands, stretching, and sensory activities such as aromatherapy and deep breathing.
Assessments: Researchers will evaluate physical indicators and psychological well-being before the program, immediately after, and at a 1-month follow-up.
Goal: We hope to determine if combining structured exercise with the forest environment can effectively improve the health and quality of life for older women with sarcopenia.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Background and Rationale: Sarcopenia is a common skeletal muscle disease in the elderly characterized by the loss of muscle mass, strength, and physical performance. While resistance training and nutrition are core management strategies, Forest Healing has been shown to reduce stress (cortisol), regulate the autonomic nervous system, and improve immune function. This study aims to validate a standardized "manualized" forest healing intervention for sarcopenia, utilizing a cross-border collaboration framework between Taiwan and South Korea.
Study Design & Environmental Monitoring: This is a single-arm, pre-post intervention study (quasi-experimental design) conducted at the Caoling Shibi Forest Healing Base (altitude 1,500-1,700m). A unique aspect of this trial is the quantification of environmental factors, including phytoncide concentrations, negative ions, and thermal comfort indices (PMV, PPD), to explore the mechanistic relationship between the forest environment and physiological adaptations.
Intervention Protocol: The standardized 180-minute sessions are designed to integrate physical conditioning with psychological relaxation. The technical protocol dictates:
Aerobic and Balance Training: Forest trail walking maintained at a Rating of Perceived Exertion (RPE) of 12-13.
Resistance Training: Elastic band exercises targeting upper and lower limbs (3 sets of 8-10 repetitions) at an RPE of 9-13.
Core Forest Therapy: Sensory awareness, aromatherapy, and deep breathing to promote parasympathetic activation.
Psychological Promotion: Facilitated group interactions and experience sharing to enhance social connection and intervention adherence.
Safety Protocol: To ensure participant safety in a mountainous terrain, the study has established a comprehensive three-tier medical safety mechanism. This includes on-site first aid by certified instructors, local AED medical services, and a dedicated emergency medical "green channel" established with the National Taiwan University Hospital, Yunlin Branch.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Yunlin County, Taiwan, 640
- National Taiwan University Hospital Yunlin Branch
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Female aged 55 years or older.
- Meet the AWGS 2025 criteria for sarcopenia (low handgrip strength and low skeletal muscle mass index).
- Able to walk independently or with assistive devices and safely participate in low-to-moderate intensity exercise training.
- Willing to commit to the 8-week intervention (16 sessions total) and provide signed informed consent.
Exclusion Criteria:
- History of major acute illness, hospitalization, or surgery within the past 3 months.
- Severe cardiovascular, respiratory, or other systemic diseases that make moderate-intensity exercise unsafe.
- Severe osteoarticular or neurological disorders that significantly impair walking or exercise safety.
- Severe cognitive impairment that prevents understanding of study procedures or cooperation with the intervention.
- Presence of implanted medical devices (e.g., pacemakers) that would interfere with bioelectrical impedance analysis (BIA).
- Regular participation in structured resistance training or high-intensity exercise within the past 3 months.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Forest-Based Intervention Group
Participants will undergo an 8-week structured forest healing program (2 sessions/week, 16 sessions total) at the Caoling Shibi Forest Healing Base . Each 180-minute session, led by certified instructors, includes forest trail walking (aerobic/balance), elastic band resistance training, nature-based sensory immersion (forest therapy), and group psychological support. The intervention follows a standardized manual focused on improving muscle strength and physical function. |
An 8-week structured intervention (16 sessions total, 180 min each) conducted at the Caoling Shibi Forest Healing Base.
The program integrates physical exercise (forest trail walking and elastic band resistance training) with nature-based sensory immersion (aromatherapy, deep breathing, and nature awareness).
The intervention follows a manualized protocol led by certified instructors, specifically designed to improve muscle strength, physical function, and psychological well-being in older women.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Handgrip Strength
Prazo: Baseline, 2 months, and 3 months.
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Measured using a Smedley hand dynamometer for the dominant hand to evaluate maximum muscle strength.
Handgrip strength is a key clinical indicator for sarcopenia diagnosis.
Values are reported in kilograms (kg).
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Baseline, 2 months, and 3 months.
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Short Physical Performance Battery (SPPB)
Prazo: Baseline, 2 months, and 3 months.
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A standardized assessment of lower extremity function, including balance tests, gait speed tests, and five times chair stand tests. Scale title: Short Physical Performance Battery (SPPB). Minimum value: 0, Maximum value: 12. Higher scores indicate better physical performance. |
Baseline, 2 months, and 3 months.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Skeletal Muscle Mass Index (SMI)
Prazo: Baseline, 2 months, and 3 months.
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Measured via Bioelectrical Impedance Analysis (BIA) using the ACCUNIQ BC380.
It is calculated as Appendicular Skeletal Muscle mass divided by height squared to track muscle mass changes.
Values are reported in kg/m2.
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Baseline, 2 months, and 3 months.
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Health-Related Quality of Life (SF-36)
Prazo: Baseline, 2 months, and 3 months.
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Assessed using the Taiwan version of the Short Form-36 Health Survey (SF-36) to evaluate the participant's physical and mental health status. Scale title: 36-Item Short Form Health Survey (SF-36). Minimum value: 0, Maximum value: 100. Higher scores indicate better outcomes (better health-related quality of life). |
Baseline, 2 months, and 3 months.
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Geriatric Depression Scale (SGDS)
Prazo: Baseline, 2 months, and 3 months.
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The Taiwan short-form version (GDS-15) is used to evaluate changes in depressive symptoms among participants based on their feelings over the past week. The assessment consists of 15 questions. Scale title: 15-item Geriatric Depression Scale (GDS-15). Minimum value: 0, Maximum value: 15. Higher scores indicate worse outcomes (more severe depressive symptoms). |
Baseline, 2 months, and 3 months.
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Pittsburgh Sleep Quality Index (PSQI)
Prazo: Baseline, 2 months, and 3 months.
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The Taiwan version is used to assess sleep habits and quality over the previous month, calculating a global total score. Scale title: Pittsburgh Sleep Quality Index (PSQI). Minimum value: 0, Maximum value: 21. Higher scores indicate worse outcomes (poorer sleep quality). |
Baseline, 2 months, and 3 months.
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Positive and Negative Affect Schedule (PANAS)
Prazo: Baseline, 2 months, and 3 months.
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Used to measure changes in emotional states following the forest healing intervention based on actual feelings over the past week. The questionnaire consists of 20 items rated on a 1 to 5 scale. Scale title: Positive and Negative Affect Schedule (PANAS). This assessment comprises two subscales.
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Baseline, 2 months, and 3 months.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kai-Chieh Chang, MD, National Taiwan University Hospital
Publicações e links úteis
Publicações Gerais
- Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
- Hansen MM, Jones R, Tocchini K. Shinrin-Yoku (Forest Bathing) and Nature Therapy: A State-of-the-Art Review. Int J Environ Res Public Health. 2017 Jul 28;14(8):851. doi: 10.3390/ijerph14080851.
- Chen N, He X, Feng Y, Ainsworth BE, Liu Y. Effects of resistance training in healthy older people with sarcopenia: a systematic review and meta-analysis of randomized controlled trials. Eur Rev Aging Phys Act. 2021 Nov 11;18(1):23. doi: 10.1186/s11556-021-00277-7.
- Woo J, Lee CJ. Sleep-enhancing Effects of Phytoncide Via Behavioral, Electrophysiological, and Molecular Modeling Approaches. Exp Neurobiol. 2020 Apr 30;29(2):120-129. doi: 10.5607/en20013.
- Baek JE, Jung JH, Shin HJ, Kim SH, Sung SY, Park SJ, Hahm SC, Cho HY, Lee MG. Effects of Forest Healing Anti-Aging Program on Psychological, Physiological, and Physical Health of Older People with Mild Cognitive Impairment. Int J Environ Res Public Health. 2022 Apr 16;19(8):4863. doi: 10.3390/ijerph19084863.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Manifestações Neuromusculares
- Transtornos Mentais, Desordem Mental
- Condições Patológicas, Anatômicas
- Distúrbios do Sono Vigília
- Distúrbios do Sono Intrínsecos
- Dissônias
- Atrofia Muscular
- Atrofia
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Sinais e sintomas
- Satisfação pessoal
- Distúrbios de Iniciação e Manutenção do Sono
- Sarcopenia
- Bem-estar psicológico
- Terapêutica
- Terapias mente-corpo
- Terapias complementares
- Terapia de relaxamento
- Terapia florestal
Outros números de identificação do estudo
- 202603112RINA
Plano para dados de participantes individuais (IPD)
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