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

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.

Causes of Patient Nonattendance at Medical Appointments: Protocol for a Mixed Methods Study.

BACKGROUND: Approximately one-third of patient appointments in Danish health care result in failures, leading to patient risk and sizable resource waste. Existing interventions to alleviate no-shows often target the patients. The underlying reason behind these interventions is a view that attendance or nonattendance is solely the patient's problem. However, these interventions often prove to be ineffective and can perpetuate social biases and health inequalities, leaving behind patients who are more vulnerable or disadvantaged (in terms of social, economical, and linguistic factors, etc). A more holistic understanding of no-shows is needed to optimize processes, reduce waste, and support patients who are vulnerable. OBJECTIVE: This study aims to gain a deep and more comprehensive understanding of the causes, mechanisms, and recurring patterns and elements contributing to nonattendance at Danish hospitals in the Region of Southern Denmark. It emphasizes the patient perspective and analyzes the relational and organizational processes surrounding no-shows in health care. In addition, the study aims to identify effective communicative strategies and organizational processes that can support the development and implementation of successful interventions. METHODS: The study uses mixed quantitative-qualitative methods, encompassing 4 analytical projects focusing on nonattendance patterns, patient knowledge and behavior, the management of hospital appointments, and in situ communication. To address the complexity of no-shows in health care, the study incorporates various data sources. The quantitative data sources include the electronic patient records, Danish central registries, Danish National Patient Registry, and Register of Medicinal Product Statistics. Baseline characteristics of patients at different levels are compared using chi-square tests and Kruskal-Wallis tests. The qualitative studies involve observational data, individual semistructured interviews with patients and practitioners, and video recordings of patient consultations. RESULTS: This paper presents the protocol of the study, which was funded by the Novo Nordisk Foundation in July 2022. Recruitment started in February 2023. It is anticipated that the quantitative data analysis will be completed by the end of September 2023, with the qualitative investigation starting in October 2023. The first study findings are anticipated to be available by the end of 2024. CONCLUSIONS: The existing studies of nonattendance in Danish health care are inadequate in addressing relational and organizational factors leading to hospital no-shows. Interventions have had limited effect, highlighting the Danish health care system's failure to accommodate patients who are vulnerable. Effective interventions require a qualitative approach and robust ethnographic data to supplement the description and categorization of no-shows at hospitals. Obtaining comprehensive knowledge about the causes of missed patient appointments will yield practical benefits, enhancing the safety, coherence, and quality of treatment in health care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46227.