K50 K51
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Women and men with ulcerative colitis and Crohn's disease - Moderate to medium disease activity (ulcerative colitis: pMayo score up to 7 points, Crohn's disease: CDAI up to 300 points) - Signed declaration of consent - Signed transfer agreement
Exclusion criteria
Exclusion criteria: - Additional training in both study groups - Combobidities that make training impossible (e.g. immobilization, serious myopathies) - Limited ability to cooperate (e.g. serious psychiatric and / or neurological diseases) - Steroid therapy above the Cushing threshold dosage (e.g. hydrocortisone 30 mg / day for men) - Existing pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Quality of life (measured via EQ-5D) 2. physical activity (before and after the intervention, measured over 1 week with activity sensors). 2. inflammatory bowel disease activity (bowel wall sonography, inflammatory markers (CRP, TNF-alpha, IL 6, IL 8, IL 10, IL-2 receptor, calprotectin)) (pre- and post-intervention, baseline and outcome assessment). 3. normalisation of stool frequency/consistency (Bristol Stool Scale) (daily recall) | — |
Secondary
| Measure | Time frame |
|---|---|
| DAILY QUESTIONING via app: Sleep quality, state of health, positive and negative affect (SAM-Scale) MEASUREMENTS BEFORE and AFTER the intervention, baseline and post measurement: - Anxiety and depressive symptoms (HADS, PHQ-9) - Quality of life (EQ-5D-5L) - Inflammatory Bowel Disease Questionnaire (IBDQ-Deutsch) - Anthropometry (weight, height, waist circumference, body fat percentage). - Clinical chemistry (differential blood count, creatinine, urea, sodium, potassium, calcium, magnesium, phosphate, total protein, albumin, lipids (total cholesterol, triglycerides, LDL, HDL), ferritin, transferrin saturation, TSH, ACTH, cortisol, kynurenine, PGC1-alpha, IGF1 - Muscle mass - Physical performance (hand strength, spiroergometry) - Cardiac function (echocardiography, esp. diastolic function, right ventricular and atrial function, ECG) Safety endpoints: serious side effects, injuries, changes in vital functions, changes in laboratory parameters | — |
Countries
Germany
Contacts
Universitätsklinikum Ulm, Zentrum für Innere Medizin, Sektion Sport- und Rehabilitationsmedizin