Back to resultsEffects of Nature and Forest Therapy in Patients With Metabolic Syndrome and Cardiovascular Risk Factors
Primary Purpose
Metabolic Syndrome, Protection Against
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Forest Therapy (Düppeler Forst - Berlin-Wannsee)
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome, Protection Against focused on measuring Forest Therapy, Forest Bathing, Shinrin Yoku, Metabolic Syndrome, Cardiovascular Risks
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
Sites / Locations
- Charité Hochschulambulanz für Naturheilkunde am Immanuel KrankenhausRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Forest Therapy (Düppeler Forst - Berlin-Wannsee)
Waiting list
Arm Description
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.
Subjects don't receive any therapy but are offered the same treatment after trial is finished.
Outcomes
Primary Outcome Measures
• Final sum score of cardiovascular risk profile (overweight, blood pressure, blood lipids, blood glucose) according to Wiley/Carrington
Secondary Outcome Measures
• 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
• 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.
• 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
• 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
• Hospital Anxiety and Depression Scale (HADS)
• Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)
Assessing full scale, range 0-56, higher score meaning a better outcome
• 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
• 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
• Weekly query of the exercise practice by means of (online) diary
Subjective Vitality Scale state (SVS-G state)
Assessing full scale, range 1-80, higher score meaning a better outcome
Perceived Benefits of Nature Questionnaire (PBNQ)
Assessing full scale, range 1-7, lower score meaning a better outcome
Profile of Mood States (POMS)
Full Information
NCT ID
NCT04781491
First Posted
February 23, 2021
Last Updated
October 24, 2023
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT04781491
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Protection Against
Keywords
Forest Therapy, Forest Bathing, Shinrin Yoku, Metabolic Syndrome, Cardiovascular Risks
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Forest Therapy (Düppeler Forst - Berlin-Wannsee)
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
Subjects don't receive any therapy but are offered the same treatment after trial is finished.
Intervention Type
Behavioral
Intervention Name(s)
Forest Therapy (Düppeler Forst - Berlin-Wannsee)
Intervention Description
Forest Therapy means mindful visits in nature, actively perceiving the flora and fauna
Primary Outcome Measure Information:
Title
• Final sum score of cardiovascular risk profile (overweight, blood pressure, blood lipids, blood glucose) according to Wiley/Carrington
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary Outcome Measure Information:
Title
• Perceived Stress Scale (PSS)
Description
Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived•stress. Higher score meaning more stress
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
• Short Form 12 Health Survey (SF-12)
Description
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.
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
• Physical complaints (B-LR - Beschwerden-Liste)
Description
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
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
• Flourishing Scale (FS-D)
Description
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
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
• Hospital Anxiety and Depression Scale (HADS)
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
• Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)
Description
Assessing full scale, range 0-56, higher score meaning a better outcome
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
• General Self-Efficacy Short Scale (ASKU-Allgemeine Selbstwirksamkeit Kurzskala)
Description
Measurement instrument for recording subjective competence expectations. Scale ranging from 1-5, higher score meaning a better outcome
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
• International Physical Activity Questionnaire (IPAQ)
Description
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
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
• Weekly query of the exercise practice by means of (online) diary
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
Subjective Vitality Scale state (SVS-G state)
Description
Assessing full scale, range 1-80, higher score meaning a better outcome
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
Perceived Benefits of Nature Questionnaire (PBNQ)
Description
Assessing full scale, range 1-7, lower score meaning a better outcome
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Title
Profile of Mood States (POMS)
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Other Pre-specified Outcome Measures:
Title
- Blood count
Description
Laboratory parameters
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
- Blood lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)
Description
Laboratory parameters
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
- Parameters of glucose metabolism (insulin, glucose, HbA1C, insulin sensitivity)
Description
Laboratory parameters will be combined to report Diabetes status
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
- liver function (GOT, GPT, GGT)
Description
Laboratory parameters
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
- Inflammation: hs-CRP, IL-6
Description
Laboratory parameters
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
- IFN-gamma, tumor necrosis factor alpha
Description
Laboratory parameters
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
- uric acid
Description
Laboratory parameters
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
- Lymphocyte populations: T cells (CD3), B cells (CD19), NK cells (CD16).
Description
Laboratory parameters
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
- T cell subpopulations: T helper cells (CD4), cytotoxic T cells (CD8), CD4/CD8 ratio.
Description
Laboratory parameters
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
- ferritin
Description
Laboratory parameters
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
- cumulative steroid hormone concentration of the last 2 months in a hair strand
Description
Laboratory parameters
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
• Apparatus parameters
Description
Body weight
abdominal girth
blood pressure measurement (24h) will be combined to report metabolic syndrome
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
• Qualitative evaluation (focus group interviews)
Description
- Semi-structured interviews and focus group discussions with 16 subjects of the intervention group.
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
• Heart rate variability and other parameters
Description
- 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.
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
- bioelectrical impedance analysis (BIA)
Description
Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg)
Time Frame
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks]
Title
Heart Rate (HR)
Description
24h measuring by smartwatch
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Heart Rate Variability (HRV)
Description
24h measuring by smartwatch
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Interbeat Interval (IBI)
Description
24h measuring by smartwatch
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Number of steps
Description
24h measuring by smartwatch
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Rösner
Phone
00493080505682
Email
m.roesner@immanuel.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Michalsen, Prof. Dr.
Organizational Affiliation
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
City
Berlin
ZIP/Postal Code
14109
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Rösner, study nurse
Phone
00493080505682
Email
m.roesner@immanuel.de
First Name & Middle Initial & Last Name & Degree
Andreas Michalsen, Prof. Dr.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effects of Nature and Forest Therapy in Patients With Metabolic Syndrome and Cardiovascular Risk Factors
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