Effects of Nature and Forest Therapy in Patients With Metabolic Syndrome and Cardiovascular Risk Factors - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- • Final sum score of cardiovascular risk profile (overweight, blood pressure, blood lipids, blood glucose) according to Wiley/Carrington
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
• Final sum score of cardiovascular risk profile (overweight, blood pressure, blood lipids, blood glucose) according to Wiley/Carrington
时间窗: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
次要结局
- • Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks])
- • International Physical Activity Questionnaire (IPAQ)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks])
- • Flourishing Scale (FS-D)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks])
- • Perceived Stress Scale (PSS)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks])
- • Hospital Anxiety and Depression Scale (HADS)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks])
- Profile of Mood States (POMS)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- • Weekly query of the exercise practice by means of (online) diary(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks])
- • Short Form 12 Health Survey (SF-12)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks])
- • Physical complaints (B-LR - Beschwerden-Liste)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks])
- Perceived Benefits of Nature Questionnaire (PBNQ)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- • General Self-Efficacy Short Scale (ASKU-Allgemeine Selbstwirksamkeit Kurzskala)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks])
- Subjective Vitality Scale state (SVS-G state)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
研究者
Andreas Michalsen
Prof.Dr.med
Charite University, Berlin, Germany