Effects of Nature and Forest Therapy in Patients With Metabolic Syndrome and Cardiovascular Risk Factors

NCT ID: NCT04781491

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-27
• Study Completion Date: 2024-12-31

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).

Conditions

Metabolic Syndrome, Protection Against

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Forest Therapy (Düppeler Forst - Berlin-Wannsee)

Subjects receive a 90-minute Forest Therapy session once per week for 8 weeks with a licensed nature therapist, who explains exercises on perceiving nature and the connection between nature and health.

Group Type: EXPERIMENTAL

Forest Therapy (Düppeler Forst - Berlin-Wannsee)

Intervention Type: BEHAVIORAL

Forest Therapy means mindful visits in nature, actively perceiving the flora and fauna

Waiting list

Subjects don't receive any therapy but are offered the same treatment after trial is finished.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Forest Therapy (Düppeler Forst - Berlin-Wannsee)

Forest Therapy means mindful visits in nature, actively perceiving the flora and fauna

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Andreas Michalsen

Prof.Dr.med

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Michalsen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Locations

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Miriam Rösner

Role: CONTACT

m.roesner@immanuel.de

00493080505682

Facility Contacts

Miriam Rösner, study nurse

Role: primary

m.roesner@immanuel.de

00493080505682

Other Identifiers

Wald

Identifier Type: -

Identifier Source: org_study_id