E11
Conditions
Interventions
Group 1: Participants of group A get following interventions as group-therapeutical offer (15 weekly dates): Excercise therapy, stress management and education, eurythmy, modeling, nutritional/diatery
Sponsors
Forschungsinstitut Havelhöhe (FIH)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diabetes mellitus Type 2, first diagnosis = 8 years, 2. HbA1c = 6,5%, 3. BMI = 25 - 40, 4. Age: = 18 und = 75, 5. Ability to take part in activity exercise therapy and in the other planned interventions, 6. Patient is able to understand the essence and the meaning of the study and is linguistically able to fill out the questionnaires.
Exclusion criteria
Exclusion criteria: 1. Insulin therapy, 2. Myocardial infarction, pulmonary artery embolism or stroke in the last 6 months, 3. Unstable angina pectoris (AP), 4. heart insufficiency= NYHA 3, 5. COPD = GOLD grade 3, 6. Peripheral artery disease (PAD) = Fontaine stage 2a, 7. Known high grade renal insufficiency, 8. Manifest major depression: VAS Depression = 60, 9. Other high grade organic or psychological disease that requires treatment, 10. Pregnancy and lactation period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Due to the intervention it will come to an improvement of the metabolic state, the quality of life, the sleep quality, the autonomic regulation (aR), the rest/activity regulation, and the self-regulation (SR). The improvement of the metabolic state will be captured by determination of HbA1c at day of study inclusion , after 9 weeks of interventions and at the end of the interventions (at the end of the study) and by determination of further parameters (S-insulin, S-glucose (HOMA index), adiponectin, LDL-C, HDL-C, Non-HDL-C, TG, total cholestorol, blood pressure, heart rate and actigraphy) at day of study inclusion and after the interventions (at the end of the study). The sleep quality will be determined by Pittsburgh Sleep Quality Index (PSQI) and life quality by General quality of life questionnaire (SF-12) at day of study inclusion, as baseline at the first day of the study (before start of interventions), and after the interventions (at the end of the study). The autonomic regulation and the rest-/activity regulation will be collected by 18-item Trait autonomic Regulation questionnaire, self-regulation by 16-item self-regulation questionnaire at day of study inclusion and as baseline at the first day of the study (before start of interventions), after nine weeks of interventions, and after the interventions (at the end of the study). Additionaly further parameters will be captured at particular time points. | — |
Secondary
| Measure | Time frame |
|---|---|
| In the course of this study the new developed questionnaire to the Inner Congruence with the Modeling Therapy (ICModThe) should be validated. | — |
Countries
Germany
Contacts
Public ContactDanilo Pranga
Forschungsinstitut Havelhöhe (FIH)
Outcome results
None listed