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Paediatrics
Protocol
Protocol of a randomised controlled trial assessing the impact of physical activity on bone health in children with inflammatory bowel disease
  1. Jérémy Vanhelst1,
  2. Stéphanie Coopman2,
  3. Julien Labreuche3,
  4. Claire Dupont4,
  5. Valérie Bertrand5,
  6. Djamal Djeddi6,
  7. Dominique Turck1,2,
  8. Delphine Ley1,2
  1. 1Univ. Lille, Inserm, CHU Lille, U1286 - INFINITE - Institute for Translational Research in Inflammation, F-59000 Lille, France, Lille, France
  2. 2Division of Gastroenterology, Hepatology and Nutrition, Department of Paediatrics, Lille University, Jeanne de Flandre Children’s Hospital, Lille, France
  3. 3Univ. Lille, CHU Lille, ULR 2694 – METRICS: Evaluation des technologies de santé et des pratiques médicales, F-59000 Lille, France, Lille, France
  4. 4Department of Paediatrics, Caen University Hospital F 14000 Caen, France and Normandy University, Caen, France
  5. 5Pediatric Unit, Le Havre Hospital, Le Havre, France
  6. 6Department of Paediatrics, Amiens University Hospital and University of Amiens, Amiens, France
  1. Correspondence to Dr Jérémy Vanhelst; jeremy.vanhelst{at}chru-lille.fr

Abstract

Introduction Low bone mineral density (BMD) is a frequent issue in children and adolescents with inflammatory bowel disease (IBD). Several studies in healthy populations have reported a positive impact of physical activity (PA) on bone health. Recently, an observational study in paediatric patients with IBD showed a significant positive relationship between daily PA and BMD. However, intervention studies investigating a causal relationship between PA and BMD are warranted to confirm these results. The aim of this randomised controlled trial will be to investigate the effect of a PA programme on BMD in paediatric patients with IBD.

Methods and analysis This trial is a multicentre (four centres), randomised, controlled, blinded end-point study. Eighty children with IBD will be randomly assigned in a 1:1 ratio to receive a programme with adapted physical exercises (intervention group) or usual PA (control group) during a 9-month period. The primary outcome is the change from baseline at 9 months (the end of the study) in whole-body BMD assessed by dual-energy X-ray absorptiometry. Secondary efficacy outcomes include the changes from baseline at 9 months in: BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.

Ethics and dissemination The study was approved by the Research Ethics Committee in France (Comité de Protection des Personnes, Sud-Ouest and Outre-Mer III, Bordeaux, France, No 2018/27). All procedures will be performed according to the ethical standards of the Helsinki Declaration of 1975, as revised in 2008, and the European Union’s Guidelines for Good Clinical Practice. Written informed consent will be obtained from the parents or legal guardian and from the children. Research findings will be disseminated in peer-reviewed journals and scientific meetings.

Trial registration number NCT03774329.

  • paediatrics
  • paediatric gastroenterology
  • sports medicine
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-036400

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    Footnotes

    • Contributors Design of the study: JV led development of the original proposal in collaboration with DL, SC and DT. JV, DL SC, JL and DT contributed to the development of the common protocol and procedures. Coordination of the study: JV, SC, DL, CD, VB, DD and DT. Wrote the manuscript: JV, DL and DT wrote the first draft. JV, DL, SC, JL, DT, CD, VB and DD contributed to subsequent drafts, read and approved the final manuscript.

    • Funding This work was supported by a grant from the French Ministry of Health (PHRC interregional N_ COOS01F1608C1093/API-16-25).

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.