Inflammatory Bowel Disease treated with Exercise, Mindfulness and Strength Training

Not Applicable

Conditions: K50
K51
Crohn disease [regional enteritis]
Ulcerative colitis

Registration Number: DRKS00023905

Lead Sponsor: niversitätsklinikum Ulm, Kliniken am Safranberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 184

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

- 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Quality of life (measured via EQ-5D)<br><br>2. physical activity <br>(before and after the intervention, measured over 1 week with activity sensors).<br><br>2. inflammatory bowel disease activity (bowel wall sonography, inflammatory markers (CRP, TNF-alpha, IL 6, IL 8, IL 10, IL-2 receptor, calprotectin))<br>(pre- and post-intervention, baseline and outcome assessment).<br><br>3. normalisation of stool frequency/consistency (Bristol Stool Scale)<br>(daily recall)

Secondary Outcome Measures

Name	Time	Method
DAILY QUESTIONING via app:<br>Sleep quality, state of health, positive and negative affect (SAM-Scale)<br><br>MEASUREMENTS BEFORE and AFTER the intervention, baseline and post measurement:<br>- Anxiety and depressive symptoms (HADS, PHQ-9)<br>- Quality of life (EQ-5D-5L)<br>- Inflammatory Bowel Disease Questionnaire (IBDQ-Deutsch)<br>- Anthropometry (weight, height, waist circumference, body fat percentage).<br>- 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<br>- Muscle mass<br>- Physical performance (hand strength, spiroergometry)<br>- Cardiac function (echocardiography, esp. diastolic function, right ventricular and atrial function, ECG)<br><br>Safety endpoints: serious side effects, injuries, changes in vital functions, changes in laboratory parameters