Effects of a Clinical Dietary Intervention During Inpatient Treatment (Modified Fasting in Metabolic Syndrome, Osteoarthritis of the Hip or Knee, Rheumatoid Arthritis and Fibromyalgia)
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Health Assessment Questionnaire (HAQ)
研究概览
简要总结
The purpose of the study is a scientific and prospective documentation of the clinical effects of an inpatient treatment at the Immanuel Hospital of Berlin, in the department for complementary and integrative medicine, with the use of a modified fasting regime. A pre- and post- as well as group comparisons are planned. Patients that are admitted to the inpatient department for metabolic syndrome, osteoarthritis of the hip or knee, rheumatoid arthritis and fibromyalgia will be enrolled in the study.
详细描述
At the beginning, during and at the end of the treatment at the inpatient department routine blood parameters, anthropometric parameters and certain scores and parameters specific to the different conditions will be measured. Questionnaires will be filled out by patients before and after the treatment as well as 3, 6 and 12 months after leaving the inpatient department.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is consents to participating in the trial during the first 24h of his or her stay in the inpatient naturopathic department of the Immanuel Hospital.
- •Written informed consent is given
- •The referral diagnosis is one of the following: diabetes mellitus type 2/metabolic syndrome, osteoarthritis of the hip, osteoarthritis of the knee, rheumatoid arthritis, fibromyalgia.
排除标准
- •Language barries to understanding the instructions of the study personnel
- •Dementia or other strong cognitive impairment
- •Pregnant or lactating women
- •Taking part in another study at the same time
结局指标
主要结局
Health Assessment Questionnaire (HAQ)
时间窗: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
Questionnaire; Change from Baseline in the HAQ, range from 0 to 3 while higher values meaning a higher grade of disability
Disease Activity Score 28 (DAS 28)
时间窗: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
Questionnaire with Clinical Examination; Change from Baseline in the DAS-28, range from 2.0 to 10.0 while higher values meaning a higher disease activity and below of 2.6 meaning remission
Summary of Diabetes Self Care Activities Measure (SDSCA)
时间窗: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
Questionnaire; 11 items with each item scored on a scale of 0-7.
Fibromyalgia Impact Questionnaire (FIQ)
时间窗: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
Questionnaire; The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. Thus the maximum possible score is 100. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
Questionnaire consisting of 24 items divided into 3 subscales: Pain (5items), Stiffness (2 items), Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher values meaning a higher grade of disability.
次要结局
- Quality of Life (WHO-5)(Change Baseline, 2 weeks, 3 months, 6 months, 12 months)
- Body-Mass-Index (BMI)(Change Baseline, 2 weeks)
- Blood count(Change Baseline, 2 weeks)
- Heart Rate Variability(Change Baseline, 2 weeks)
- Heart Rate(Change Baseline, 2 weeks)
- Blood pressure(Change Baseline, 2 weeks)
- Glomerular filtration rate (GFR)(Change Baseline, 2 weeks)
- CRP(Change Baseline, 2 weeks)
- Blood lipids(Change Baseline, 2 weeks)
- Liver enzymes (GOT, GPT)(Change Baseline, 2 weeks)
- Stepcounter(Change Baseline, 2 weeks)
- Blood Oxygenation(Change Baseline, 2 weeks)
- Pain on Visual Analogue Scale (VAS)(Change Baseline, 2 weeks, 3 months, 6 months, 12 months)
- Hospital Anxiety and Depression Scale (HADS)(Change Baseline, 2 weeks, 3 months, 6 months, 12 months)
- Perceived Stress Scale (PSS)(Change Baseline, 2 weeks, 3 months, 6 months, 12 months)
- 24h-Blood pressure(Change Baseline, 2 weeks)
研究者
Andreas Michalsen
Principal Investigator
Charite University, Berlin, Germany