- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Study Activities: Participants will take part in a structured program at the Caoling Shibi Forest Healing Base in Yunlin.
Duration: The program lasts for 8 weeks, with 2 sessions per week (16 sessions total). Each session is approximately 180 minutes.
Activities: The program includes forest trail walking, resistance training using elastic bands, stretching, and sensory activities such as aromatherapy and deep breathing.
Assessments: Researchers will measure muscle mass, handgrip strength, walking speed, and balance. Participants will also complete questionnaires regarding their mood, sleep quality, and quality of life. These assessments occur before the program, immediately after, and at a 2-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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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: This is a single-arm, pre-post intervention study (quasi-experimental design). The study will recruit 36 women aged 55 or older who meet the AWGS 2025 criteria for sarcopenia (low handgrip strength and low skeletal muscle mass index).
Intervention Protocol: The intervention occurs at the Caoling Shibi Forest Healing Base (altitude 1,500-1,700m). Each 180-minute session includes:
Aerobic and Balance Training: Forest trail walking at a Rating of Perceived Exertion (RPE) of 12-13.
Resistance Training: Elastic band exercises for upper and lower limbs (3 sets of 8-10 repetitions) at RPE 9-13.
Core Forest Therapy: Sensory awareness, aromatherapy, and deep breathing to promote relaxation.
Psychological Promotion: Group interactions and experience sharing to enhance social connection and motivation.
Outcome Measures:
Primary Outcomes: Muscle strength (measured by handgrip dynamometer) and physical performance (Short Physical Performance Battery, SPPB).
Secondary Outcomes: Muscle mass (measured via BIA), health-related quality of life (SF-36), geriatric depression (SGDS), and sleep quality (PSQI).
Environmental Monitoring: The study will also quantify environmental factors, including phytoncide concentrations, negative ions, and thermal comfort indices (PMV, PPD) to explore the relationship between the environment and health outcomes.
Safety Protocol: To ensure participant safety in a mountain environment, the study has established a three-tier medical safety mechanism, including on-site first aid by certified instructors, local AED medical services, and an emergency medical "green channel" to National Taiwan University Hospital, Yunlin Branch.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Kai-Chieh Chang, MD
- Numero di telefono: +886972652523
- Email: b94401022@ntu.edu.tw
Backup dei contatti dello studio
- Nome: Chia-Min Lin, PhD Student
- Numero di telefono: +886932651793
- Email: paul610478lin@hotmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
Female aged 55 years or older. Meet the AWGS 2019 criteria for sarcopenia (including 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Handgrip Strength
Lasso di tempo: Baseline, 8 weeks, and 4 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.
|
Baseline, 8 weeks, and 4 months.
|
|
Short Physical Performance Battery (SPPB)
Lasso di tempo: Baseline, 8 weeks, and 4 months.
|
A standardized assessment of lower extremity function, including balance tests, gait speed tests, and five times chair stand tests.
Scores range from 0 to 12, with higher scores representing better physical performance.
|
Baseline, 8 weeks, and 4 months.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Skeletal Muscle Mass Index (SMI)
Lasso di tempo: Baseline, 8 weeks, and 4 months.
|
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.
|
Baseline, 8 weeks, and 4 months.
|
|
Health-Related Quality of Life (SF-36)
Lasso di tempo: Baseline, 8 weeks, and 4 months.
|
Assessed using the Taiwan version of the Short Form-36 Health Survey, covering eight domains of physical and mental health.
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Baseline, 8 weeks, and 4 months.
|
|
Geriatric Depression Scale (SGDS)
Lasso di tempo: Baseline, 8 weeks, and 4 months.
|
The Taiwan short-form version (SGDS) is used to evaluate changes in depressive symptoms among participants.
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Baseline, 8 weeks, and 4 months.
|
|
Pittsburgh Sleep Quality Index (PSQI)
Lasso di tempo: Baseline, 8 weeks, and 4 months.
|
The Taiwan version is used to assess sleep quality over the previous month, including sleep duration, efficiency, and disturbances.
|
Baseline, 8 weeks, and 4 months.
|
|
Positive and Negative Affect Schedule (PANAS)
Lasso di tempo: Baseline, 8 weeks, and 4 months.
|
Used to measure changes in positive and negative emotional states following the forest healing intervention.
|
Baseline, 8 weeks, and 4 months.
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Kai-Chieh Chang, MD, National Taiwan University Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Manifestazioni neuromuscolari
- Disordini mentali
- Condizioni patologiche, anatomiche
- Disturbi del sonno e della veglia
- Disturbi del sonno, intrinseci
- Dissonnie
- Atrofia muscolare
- Atrofia
- Condizioni patologiche, segni e sintomi
- Comportamento
- Segni e sintomi
- Soddisfazione personale
- Disturbi dell'inizio e del mantenimento del sonno
- Sarcopenia
- Benessere psicologico
- Terapie
- Terapie mind-body
- Terapie complementari
- Terapia di rilassamento
- Terapia forestale
Altri numeri di identificazione dello studio
- 202603112RINA
Piano per i dati dei singoli partecipanti (IPD)
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