Physical fitness in children and adolescents with inflammatory bowel disease: protocol for a case-control study

BMJ Open. 2022 Oct 11;12(10):e063403. doi: 10.1136/bmjopen-2022-063403.

Abstract

Introduction: Inflammatory bowel disease (IBD) is a chronic disorder of the gastrointestinal tract, associated with adverse health consequences that may adversely influence physical activity and body composition in youth. These effects may lead to changes in physical fitness, which is positively associated with health-related outcomes. The aim is to assess health-related physical fitness levels in paediatric patients with IBD and to compare these levels with those in healthy matched controls.

Methods and analysis: This trial is a bicentric case-control study. Fifty paediatric patients with IBD and 50 matched healthy controls will be recruited (1:1), and physical fitness levels (cardiorespiratory fitness, muscular strength, speed/agility and flexibility) will be assessed. The primary outcome is cardiorespiratory fitness, which will be compared between children and adolescents with IBD and healthy controls matched for age, sex and body mass index class. We will assess whether the two groups differ with respect to other physical fitness components and cardiovascular risk in adulthood according to sex-specific cut-offs for a healthy cardiorespiratory fitness level in adolescents. We will identify relationships between physical fitness and characteristics of IBD, quality of life and daily physical activity.

Ethics and dissemination: This study was approved by the Research Ethics Committee (Comité de Protection des Personnes, Centre-Ouest I, Tours, France; No 2019-A02651-56) and was declared to the Commission Nationale de l'Informatique et des Libertés. All procedures will be performed according to the ethical standards of the 1975 Declaration of Helsinki, as revised in 2008, and the European Union's Guidelines for Good Clinical Practice. Written informed consent will be obtained from the youths and their parents. Research findings will be disseminated in peer-reviewed journals and scientific meetings, as well as in social media and IBD family support groups.

Trial registration number: NCT04647578.

Keywords: Inflammatory bowel disease; Paediatric gastroenterology; SPORTS MEDICINE.

Publication types

  • Clinical Trial

MeSH terms

  • Adolescent
  • Cardiorespiratory Fitness*
  • Case-Control Studies
  • Child
  • Chronic Disease
  • Female
  • Humans
  • Inflammatory Bowel Diseases* / complications
  • Male
  • Physical Fitness
  • Quality of Life

Associated data

  • ClinicalTrials.gov/NCT04647578