Clinical trial NCT04781491: Effects of Nature and Forest Therapy in Patients With Metabolic Syndrome and Cardiovascular Risk Factors
Official title: Effects of Nature and Forest Therapy in Patients With Metabolic Syndrome and Cardiovascular Risk Factors - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome, Protection Against
Keywords: Forest Therapy
Forest Bathing
Shinrin Yoku
Metabolic Syndrome
Cardiovascular Risks
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of regular forest therapy under guidance of a licensed nature therapist on patients with metabolic syndrome and cardiovascular risks

Detailed description: It is assumed that nature and forest experience has sustainable benefits for the physical and mental health of individuals with metabolic syndrome and cardiovascular risk profile. Especially co-therapeutic effects in terms of resilience and salutogenesis might effectively and sustainably promoted by nature and forest therapy.

The main objective of this study is to measure the effects of nature and forest therapy in subjects with manifest metabolic syndrome and cardiovascular risk factors. The intervention is a stay in the nature of the Düppeler Forest (Berlin-Wannsee) under the guidance of trained nature guides (90 minutes, 1x/week over 2 months), who teach exercises on the perception of nature and the connection between nature and health, movement and mindfulness. Subjects are also motivated to experience forest nature as regularly as possible (recommended ≥ 30 minutes daily). Participants of the control group will be offered a later participation in the therapy program after completion of the last study visit after 4 months (waiting list control group).

Eligibility criteria: Inclusion Criteria:

* Definition of Metabolic Syndrome according to the International Diabetes Foundation (IDF):
* waist circumference: at least 94 cm for men, at least 80 cm for women
* plus at least two of the following risk factors:
* fasting blood glucose levels of \> 100 mg/dl (\> 5.6 mmol/l) measured in blood plasma or diagnosed diabetes mellitus
* elevated triglycerides \> 150 mg/dl (\> 1.7 mmol/l) or therapy already initiated to lower triglycerides
* low HDL cholesterol: \< 40 mg/dl (\< 1.05 mmol/l) in men and \< 50 mg/dl (\< 1.25 mmol/l) in women or already initiated therapy to increase HDL
* Hypertension (from \> 130 mmHg systolic and \> 85 mmHg diastolic) or already treated hypertension

Exclusion Criteria:

* Serious acute or chronic illnesses
* Immobility or limitation of mobility due to orthopedic, neurological or other medical cause
* Participation in another study
* Serious mental illness
* Pregnancy and lactation

Primary outcomes:
measure: • Final sum score of cardiovascular risk profile (overweight, blood pressure, blood lipids, blood glucose) according to Wiley/Carrington
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary outcomes:
measure: • Perceived Stress Scale (PSS)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: • Short Form 12 Health Survey (SF-12)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: • Physical complaints (B-LR - Beschwerden-Liste)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: • Flourishing Scale (FS-D)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: • Hospital Anxiety and Depression Scale (HADS)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: • Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: • General Self-Efficacy Short Scale (ASKU-Allgemeine Selbstwirksamkeit Kurzskala)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: • International Physical Activity Questionnaire (IPAQ)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: • Weekly query of the exercise practice by means of (online) diary
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: Subjective Vitality Scale state (SVS-G state)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: Perceived Benefits of Nature Questionnaire (PBNQ)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
measure: Profile of Mood States (POMS)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Other outcomes:
measure: - Blood count
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: - Blood lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: - Parameters of glucose metabolism (insulin, glucose, HbA1C, insulin sensitivity)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: - liver function (GOT, GPT, GGT)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: - Inflammation: hs-CRP, IL-6
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: - IFN-gamma, tumor necrosis factor alpha
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: - uric acid
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: - Lymphocyte populations: T cells (CD3), B cells (CD19), NK cells (CD16).
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: - T cell subpopulations: T helper cells (CD4), cytotoxic T cells (CD8), CD4/CD8 ratio.
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: - ferritin
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: - cumulative steroid hormone concentration of the last 2 months in a hair strand
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: • Apparatus parameters
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: • Qualitative evaluation (focus group interviews)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: • Heart rate variability and other parameters
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: - bioelectrical impedance analysis (BIA)
timeFrame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
measure: Heart Rate (HR)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Heart Rate Variability (HRV)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Interbeat Interval (IBI)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Number of steps
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Locations:
city: Berlin
country: Germany
facility: Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Study officials:
affiliation: Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
name: Andreas Michalsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: