- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Yunlin County, Taiwan, 640
- National Taiwan University Hospital Yunlin Branch
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Handgrip Strength
Tijdsspanne: 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)
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Skeletal Muscle Mass Index (SMI)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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.
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Kai-Chieh Chang, MD, National Taiwan University Hospital
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neurologische manifestaties
- Ziekten van het zenuwstelsel
- Neuromusculaire manifestaties
- Psychische aandoening
- Pathologische aandoeningen, anatomisch
- Slaap-waakstoornissen
- Slaapstoornissen, intrinsiek
- Dyssomnieën
- Spieratrofie
- Atrofie
- Pathologische aandoeningen, tekenen en symptomen
- Gedrag
- Tekenen en symptomen
- Persoonlijke voldoening
- Slaapinitiatie en -onderhoudsstoornissen
- Sarcopenie
- Geestelijk welzijn
- Therapeutica
- Mind-body therapieën
- Complementaire therapieën
- Ontspanningstherapie
- Bostherapie
Andere studie-ID-nummers
- 202603112RINA
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .