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The IBD-FITT study — moderate-intensity exercise for patients with inflammatory bowel disease with moderate disease activity: an open-label randomized controlled trial: an open-label randomized controlled trial

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Title: The IBD-FITT study — moderate-intensity exercise for patients with inflammatory bowel disease with moderate disease activity: an open-label randomized controlled trial: an open-label randomized controlled trial
Authors: Ken Lund, Torben Knudsen, Jens Kjeldsen, Rasmus Gaardskær Nielsen, Carsten Bogh Juhl, Bente Mertz Nørgård
Source: Trials
Trials, Vol 24, Iss 1, Pp 1-12 (2023)
Publisher Information: Springer Science and Business Media LLC, 2023.
Publication Year: 2023
Subject Terms: Crohn's disease, Adult, Medicine (General), Inflammatory Bowel Diseases/diagnosis, Leukocyte L1 Antigen Complex/metabolism, Colitis, Crohn Disease/diagnosis, Biomarkers/metabolism, Inflammatory Bowel Diseases, Inflammatory bowel disease, 3. Good health, Study Protocol, R5-920, Ulcerative colitis, Crohn Disease, Quality of Life, Humans, Ulcerative/diagnosis, Colitis, Ulcerative, Exercise, Leukocyte L1 Antigen Complex, Biomarkers
Description: 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.
Document Type: Article
Other literature type
Language: English
ISSN: 1745-6215
DOI: 10.1186/s13063-023-07781-4
Access URL: https://pubmed.ncbi.nlm.nih.gov/37986021
https://doaj.org/article/d351d72d310d495d859b0955ccf15cb0
Rights: CC BY
URL: http://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (http://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (http://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Accession Number: edsair.doi.dedup.....37d37f8406ade341d4932b105a1a1287
Database: OpenAIRE
Description
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.
ISSN:17456215
DOI:10.1186/s13063-023-07781-4