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

Metabolic Syndrome, Protection Against Clinical Trial

Official title:

Effects of Nature and Forest Therapy in Patients With Metabolic Syndrome and Cardiovascular Risk Factors - a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04781491
• Other study ID #: Wald
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Charite University, Berlin, Germany
• Contact: Miriam Rösner
• Phone: 00493080505682
• Email: m.roesner[@]immanuel.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome, Protection Against
• Syndrome

Intervention

Behavioral:
• Forest Therapy (Düppeler Forst - Berlin-Wannsee)
Forest Therapy means mindful visits in nature, actively perceiving the flora and fauna

Locations

Country	Name	City	State
Germany	Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	- Blood count	Laboratory parameters	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Other	- Blood lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)	Laboratory parameters	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Other	- Parameters of glucose metabolism (insulin, glucose, HbA1C, insulin sensitivity)	Laboratory parameters will be combined to report Diabetes status	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Other	- liver function (GOT, GPT, GGT)	Laboratory parameters	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Other	- Inflammation: hs-CRP, IL-6	Laboratory parameters	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Other	- IFN-gamma, tumor necrosis factor alpha	Laboratory parameters	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Other	- uric acid	Laboratory parameters	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Other	- Lymphocyte populations: T cells (CD3), B cells (CD19), NK cells (CD16).	Laboratory parameters	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Other	- T cell subpopulations: T helper cells (CD4), cytotoxic T cells (CD8), CD4/CD8 ratio.	Laboratory parameters	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Other	- ferritin	Laboratory parameters	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Other	- cumulative steroid hormone concentration of the last 2 months in a hair strand	Laboratory parameters	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Other	• Apparatus parameters	Body weight; abdominal girth; blood pressure measurement (24h) will be combined to report metabolic syndrome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Other	• Qualitative evaluation (focus group interviews)	- Semi-structured interviews and focus group discussions with 16 subjects of the intervention group.	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Other	• Heart rate variability and other parameters	- Digital tracking using "wearables": parameters of stress levels and activity and sleep patterns are measured objectively using a smartwatch (fitbit). Heart rate variability (RMSSD), pulse, activity duration, type, and intensity as well as sleep duration, sleep phases, steps, and calorie consumption are recorded. The aim is to test whether the activity and pulse tracking data provide information about the variance in quality of life data. Will be combined to report quality of life.	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Other	- bioelectrical impedance analysis (BIA)	Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg)	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Other	Heart Rate (HR)	24h measuring by smartwatch	Date of inclusion (baseline), after 8 weeks, after 16 weeks
Other	Heart Rate Variability (HRV)	24h measuring by smartwatch	Date of inclusion (baseline), after 8 weeks, after 16 weeks
Other	Interbeat Interval (IBI)	24h measuring by smartwatch	Date of inclusion (baseline), after 8 weeks, after 16 weeks
Other	Number of steps	24h measuring by smartwatch	Date of inclusion (baseline), after 8 weeks, after 16 weeks
Primary	• Final sum score of cardiovascular risk profile (overweight, blood pressure, blood lipids, blood glucose) according to Wiley/Carrington		Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	• Perceived Stress Scale (PSS)	Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived•stress. Higher score meaning more stress	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Secondary	• Short Form 12 Health Survey (SF-12)	The Short Form (12) Health Survey is a 12-item, patient-reported survey of patient health.The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing. score ranging from 0-5 for each question, lower score meaning a better outcome.	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Secondary	• Physical complaints (B-LR - Beschwerden-Liste)	the Complaints List - (B-LR) is a self-assessment procedure for recording subjective impairment due to physical or general complaints, covering the entire spectrum from no complaints to severe impairment. Two parallel forms (B-LR and B-LR') are available, each consisting of 20 items, lower score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Secondary	• Flourishing Scale (FS-D)	The Flourishing Scale is a brief 8-item summary measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism. The scale provides a single psychological well-being score, ranging from 8-56, higher score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Secondary	• Hospital Anxiety and Depression Scale (HADS)		Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Secondary	• Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)	Assessing full scale, range 0-56, higher score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Secondary	• General Self-Efficacy Short Scale (ASKU-Allgemeine Selbstwirksamkeit Kurzskala)	Measurement instrument for recording subjective competence expectations. Scale ranging from 1-5, higher score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Secondary	• International Physical Activity Questionnaire (IPAQ)	The 31-item long form and the 9-item short form assess time spent on different activities. The short form records four types of physical activity: vigorous activity such as aerobics; moderate-intensity activity such as leisure cycling; walking, and sitting.; MET minutes represent the amount of energy expended carrying out physical activity. To get a continuous variable score from the IPAQ (MET minutes a week) we will consider walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS; higher score meaning better outcome; range 0 to around 3000 MET minutes a week	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Secondary	• Weekly query of the exercise practice by means of (online) diary		Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Secondary	Subjective Vitality Scale state (SVS-G state)	Assessing full scale, range 1-80, higher score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Perceived Benefits of Nature Questionnaire (PBNQ)	Assessing full scale, range 1-7, lower score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary	Profile of Mood States (POMS)		Date of Inclusion (Baseline), after 8 weeks and after 16 weeks