Short summary

We aim to investigate the effect of a 12 weeks exercise intervention in adult patients with active IBD. We randomized 150 patients by 1:1 to the exercise intervention or usual care. The intervention is a 12-week aerobic exercise program and will include two supervised exercise sessions of 60 minutes per week, combined with one weekly home training session. This trial will add to the evidence on a possible effect of exercise and might clarify whether exercise can benefit as a treatment addendum.

Rationale

The inflammatory bowel diseases (IBD), Crohn's disease and ulcerative colitis, are chronic autoimmune lifelong diseases with fluctuating activity over time. The treatment includes medical therapy and surgery, however there is no definite cure. Therefore, the quest for new and supplementary treatment options is imperative to improve patients' general health and quality of life.

Physical activity and exercise have been suggested to be elements in both the prevention and supplementary treatment of IBD, however, this is based on limited underpowered trials. Thus, the role of exercise as treatment option still has to be settled.

We aim to investigate the effect of a 12 weeks exercise intervention in adult patients with active IBD on three categories of outcomes 1) disease specific health-related quality of life (IBDQ), 2) general health status of the patients, i.e. waist circumference, disease activity by clinical scorings systems (Harvey Bradshaw Index, Simple Clinical Colitis Activity Index), blood pressure, blood lipids, and non-disease specific quality of life (EQ5D) scores and 3) explorative outcomes on biomarkers (C-reactive protein and fecal calprotectin) plus different biomarkers of immunology (cytokine panel).

Description of the cohort

We will recruit patients with Crohn's disease or ulcerative colitis from specialized gastroenterology out-patient clinics.

Age between 18-65 years. A minimum of one year disease duration. In pharmacological treatments in three months before inclusion. Fecal calprotectin (FC) > 200 mg/g or CPR>6

Data and biological material

Demografic data, medical record data, questionnarie data, blodsamples, faeces.

Collaborating researchers and departments

Department of Medicine, Hospital of Southwest Jutland, Esbjerg, Denmark.

• Professor Torben Knudsen

Department of Medical Gastroenterology S, Odense University Hospital, Odense, Denmark.

• Professor Jens Kjeldsen

Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.

• Assciate Professor Rasmus Gaardskær Nielse

Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark

• Professor Carsten Borg Juhl

Research Unit of Clinical Epidemiology, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.

• Professor Bente Mertz Nørgård