- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Yunlin County, Tchaj-wan, 640
- National Taiwan University Hospital Yunlin Branch
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Handgrip Strength
Časové okno: Baseline, 2 months, and 3 months.
|
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).
|
Baseline, 2 months, and 3 months.
|
|
Short Physical Performance Battery (SPPB)
Časové okno: Baseline, 2 months, and 3 months.
|
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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Skeletal Muscle Mass Index (SMI)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Kai-Chieh Chang, MD, National Taiwan University Hospital
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Neurologické projevy
- Nemoci nervového systému
- Neuromuskulární projevy
- Duševní poruchy
- Patologické stavy, anatomické
- Poruchy spánku a bdění
- Poruchy spánku, vnitřní
- Dysomnie
- Svalová atrofie
- Atrofie
- Patologické stavy, příznaky a symptomy
- Chování
- Příznaky a symptomy
- Osobní spokojenost
- Poruchy iniciace a udržování spánku
- Sarkopenie
- Psychická pohoda
- Terapeutika
- Terapie mysli a těla
- Doplňkové terapie
- Relaxační terapie
- Lesní terapie
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