Fibromyalgia, Metabolic Syndrome, Osteoarthritis, Hip, Osteoarthritis, Knee, Rheumatoid Arthritis
Conditions
Keywords
fasting, natural therapies, prolonged fasting
Brief summary
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.
Detailed description
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.
Interventions
OTHERProlonged modified fasting
The prolonged modified fasting is a dietary intervention with abstinence from solid foods and a caloric intake of 100-400 kcal through juices and vegetable broths
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibromyalgia Impact Questionnaire (FIQ) | 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. |
| Disease Activity Score 28 (DAS 28) | 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 |
| Health Assessment Questionnaire (HAQ) | 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 |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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. |
| Summary of Diabetes Self Care Activities Measure (SDSCA) | Change Baseline, 2 weeks, 3 months, 6 months, 12 months | Questionnaire; 11 items with each item scored on a scale of 0-7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | Change Baseline, 2 weeks | Measuring systolic and diastolic blood pressure in mmHg |
| 24h-Blood pressure | Change Baseline, 2 weeks | Measuring systolic and diastolic blood pressure with Device Mobil-O-Graph |
| Blood count | Change Baseline, 2 weeks | Laboratory test |
| Glomerular filtration rate (GFR) | Change Baseline, 2 weeks | Laboratory test |
| Blood lipids | Change Baseline, 2 weeks | triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L), fasting glucose (mmol/L) |
| Pain on Visual Analogue Scale (VAS) | Change Baseline, 2 weeks, 3 months, 6 months, 12 months | Questionnaire |
| Liver enzymes (GOT, GPT) | Change Baseline, 2 weeks | Hepatic transaminases (GPT, GOT in U/L) |
| Stepcounter | Change Baseline, 2 weeks | With Device Everion |
| Heart Rate Variability | Change Baseline, 2 weeks | With Device Faros 180 |
| Heart Rate | Change Baseline, 2 weeks | With Device Everion |
| Blood Oxygenation | Change Baseline, 2 weeks | With Device Everion |
| CRP | Change Baseline, 2 weeks | CRP in milligram per liter (mg/L) |
| Hospital Anxiety and Depression Scale (HADS) | Change Baseline, 2 weeks, 3 months, 6 months, 12 months | Questionnaire; HADS: Assessing full scale, range 0-42, lower score meaning a better outcome |
| Perceived Stress Scale (PSS) | Change Baseline, 2 weeks, 3 months, 6 months, 12 months | Questionnaire; Change from Baseline in the PSS, range from 0 to 4 in each item. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the positively stated items and then summing across all scale items while higher values meaning a higher grade of perceived stress. |
| Quality of Life (WHO-5) | Change Baseline, 2 weeks, 3 months, 6 months, 12 months | Questionnaire; Change from Baseline in the WHO-5, range from 0 to 100 % while higher values meaning a higher grade of well-being |
| Body-Mass-Index (BMI) | Change Baseline, 2 weeks | Anthropometry |
Countries
Germany
Outcome results
None listed