Impact of a Physical Activity Program on Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease (PROPHYSICOS)

Impact of a Physical Activity Program on Bone Mineral Density (BMD) in Children / Adolescents With Chronic Inflammatory Bowel Disease (IBD): Crohn's Disease, Ulcerative Colitis, Unclassified Chronic Colitis

Muscle and physical activity play an important role in in growth, development and bone health in healthy children, especially during puberty. Children with inflammatory bowel disease (IBD) have lower level and intensity of physical compared to a control group. Several studies have shown that children with IBD have a lower bone mineral density (BMD) than general population, due to risk factors such as corticosteroid use, disease intensity, inflammation, malnutrition and a vitamin D deficiency. This low BMD is associated with an increased risk of fracture. A recent observational study found a positive and significant correlation between BMD in IBD patients and time spent in moderate to vigorous physical activity for one week (unpublished data).The present study aims to show a benefit of an adapted physical activity program on BMD in children and adolescents with IBD.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease; Ulcerative Colitis; Crohn's Enteritis; Chronic; Colitis (Noninfective)
• Intervention / Treatment: Other: adapted physical activity; Other: Usual care

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stéphanie COOPMAN, MD; Phone Number: +33 0320445962; Email: stephanie.coopman@chru-lille.fr

Study Locations

• France
  • Amiens, France
    • Recruiting
    • CHU Amiens Picardie
  • Lille, France
    • Recruiting
    • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient with IBD (Crohn's disease, ulcerative colitis or unclassified chronic colitis) since at least 6 months.
• Computer and internet access at home.
• Consent to adhere to a physical activity program.
• Assent of the child to participation in the research protocol.
• Informed consent of parents or legal guardian.
• Patient benefiting from national health.

Exclusion Criteria:

• At time of inclusion, acute intercurrent events which may lead to a decrease in physical activity (according to the judgment of the investigator) as fractures, recent arthritis, ano-perineal lesions, severe dermatological lesions.
• Chronic, acute or intermittent diseases (other than IBD) that may lead to a decrease in physical activity.
• Refusal of the child to participate to the protocol.
• Refusal of one of the child's parents to participate in the protocol.
• Predictable lack of compliance to study procedures (especially to the physical activity program).
• Child with visual impairment.
• Participation in another interventional study.
• Pregnant or lactating women.
• Patient under protection of justice.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: physical activity program; Child with an adapted physical activity program	Other: adapted physical activity; Patients in the experimental group will have, in addition to their usual follow-up with their specialist doctor, an intervention in adapted physical activity at home, at the rate of 3 sessions (of a duration of 10 to 20 minutes) per week during 9 consecutive months.
OTHER: Usual care	Other: Usual care; Patients included in the control group will not benefit from the intervention in adapted physical activity. However, this will not affect their support. Patients will be seen by their specialist doctor as part of the usual management of their IBD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in total (whole body) Bone Mineral Density	At 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vertebral BMD		At 9 months
Change in femoral body BMD		At 9 months
Change in time spent (minutes / day) in moderate to vigorous physical activity measured by accelerometry for 7 days		At 9 months
Change in in fat mass measured by two-photon absorptiometry (%)		At 9 months
Change in lean mass measured by two-photon absorptiometry (kg)		At 9 months
Change IMPACT score III	related quality of life instrument in children with inflammatory bowel disease.	At 9 months
Change in pediatrics crohn's disease activity index or pediatric ulcerative colitis activity index		At 9 months
Change in biologic inflammatory parameters by decrease or increase C-reactive protein		At 9 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Stéphanie COOPMAN, MD, University Hospital, Lille

Publications and helpful links

General Publications

• Vanhelst J, Coopman S, Labreuche J, Dupont C, Bertrand V, Djeddi D, Turck D, Ley D. Protocol of a randomised controlled trial assessing the impact of physical activity on bone health in children with inflammatory bowel disease. BMJ Open. 2020 May 18;10(5):e036400. doi: 10.1136/bmjopen-2019-036400.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2020
• Primary Completion (ANTICIPATED): November 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (ACTUAL): December 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; pediatric; bone mineral density; inflammatory bowel disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Ulcer; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Enteritis; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 2017_04; 2018-A00423-52 (OTHER: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No