- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Yunlin County, Taïwan, 640
- National Taiwan University Hospital Yunlin Branch
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Handgrip Strength
Délai: 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)
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Skeletal Muscle Mass Index (SMI)
Délai: Baseline, 2 months, and 3 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.
Values are reported in kg/m2.
|
Baseline, 2 months, and 3 months.
|
|
Health-Related Quality of Life (SF-36)
Délai: Baseline, 2 months, and 3 months.
|
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.
|
|
Geriatric Depression Scale (SGDS)
Délai: Baseline, 2 months, and 3 months.
|
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.
|
|
Pittsburgh Sleep Quality Index (PSQI)
Délai: Baseline, 2 months, and 3 months.
|
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.
|
|
Positive and Negative Affect Schedule (PANAS)
Délai: Baseline, 2 months, and 3 months.
|
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.
|
Baseline, 2 months, and 3 months.
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kai-Chieh Chang, MD, National Taiwan University Hospital
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies du système nerveux
- Manifestations neuromusculaires
- Les troubles mentaux
- Conditions pathologiques, anatomiques
- Troubles du sommeil et de l'éveil
- Troubles du sommeil, intrinsèques
- Dyssomnies
- Atrophie musculaire
- Atrophie
- Conditions pathologiques, signes et symptômes
- Comportement
- Signes et symptômes
- Satisfaction personnelle
- Troubles de l'initiation et du maintien du sommeil
- Sarcopénie
- Bien-être psychologique
- Thérapeutique
- Thérapies corps-esprit
- Thérapies complémentaires
- Thérapie de relaxation
- Thérapie forestière
Autres numéros d'identification d'étude
- 202603112RINA
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .