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Inflammatory Bowel Disease treated with Exercise, Mindfulness and Strength Training

Inflammatory Bowel Disease treated with Exercise, Mindfulness and Strength Training - BODE-Smart

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00023905
Enrollment
184
Registered
2021-09-20
Start date
2023-06-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K50 K51

Interventions

Group 1: HIT + HIRT: high-intensity strength / endurance training for 12 weeks
HIT: high-intensity endurance training (walking), 3x / week 35min each: 5min warm-up, 10x1min strong exertion, alternating 10x1min break, 10min cool-down
Instructions via smartphone application HIRT: high-intensity strength training (own weight, whole body training), 2x / week 30min each: 2 training cycles of 30s intervals. Change of exercise after 4

Sponsors

Universitätsklinikum Ulm, Kliniken am Safranberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactAchim Jerg

Universitätsklinikum Ulm, Zentrum für Innere Medizin, Sektion Sport- und Rehabilitationsmedizin

achim.jerg@uniklinik-ulm.de0731-500-45300

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026