Trials. 2023 Nov 20;24(1):742.doi: 10.1186/s13063-023-07781-4.

Ken Lund ^1 2, Torben Knudsen ^3 4, Jens Kjeldsen ^5 6, Rasmus Gaardskær Nielsen ^7 8, Carsten Bogh Juhl ^9 10, Bente Mertz Nørgård ^11 12

Author information

¹Center for Clinical Epidemiology, Odense University Hospital, Odense, Denmark. ken.lund@rsyd.dk.

²Research Unit of Clinical Epidemiology, Department of Clinical Research, University of Southern Denmark, Odense, Denmark. ken.lund@rsyd.dk.

³Department of Medicine, Hospital of Southwest Jutland, Esbjerg, Denmark.

⁴Department of Regional Health Science, Center Southwest Jutland, University of Southern Denmark, Esbjerg, Denmark.

⁵Department of Medical Gastroenterology S, Odense University Hospital, Odense, Denmark.

⁶Research Unit of Medical Gastroenterology, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.

⁷Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.

⁸Research Unit of Pediatrics, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.

⁹Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.

¹⁰Department of Physiotherapy and Occupational Therapy, University of Copenhagen, Herlev and Gentofte Hospital, Copenhagen, Denmark.

¹¹Center for Clinical Epidemiology, Odense University Hospital, Odense, Denmark.

¹²Research Unit of Clinical Epidemiology, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.

Abstract

Background: Inflammatory bowel disease (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 a treatment option still has to be settled. We aim to investigate the effect of a 12-week exercise intervention in adult patients with moderately 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).

Methods: We will apply a superiority design in this open-label randomized clinical trial including 150 patients equally allocated to intervention and usual care. The intervention will be based on a 12-week aerobic exercise program and will include two supervised exercise sessions of 60 min per week, combined with one weekly home training session. We have defined a moderate exercise level as 60-80% of patients' maximum heart rate. The patients in the intervention group will also be offered an online video lesson of 15-25 min on lifestyle guidance, and the same online video lesson will be offered in the comparator group. Questionnaires on quality of life will be forwarded electronically both at inclusion and at the end of the study, and the patients will have blood samples, and fecal samples for calprotectin at baseline, weeks 4 and 8, as well as after 12 weeks (study end).

Discussion: This will be a clinical trial investigating the effect of exercise on patients with Crohn's disease and ulcerative colitis. This trial will add to the evidence on the possible effect of exercise and might clarify whether exercise can benefit as a supplementary treatment addendum. Thus, the trial may provide a new patient-active disease management approach.

Trial registration: ClinicalTrials.gov NCT04816812. Date of first registration: March 23, 2021.