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

NCT03774329 | Completed

• 2 other identifiers: 2017_042018-A00423-52
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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correlation between BMD in IBD patients and time spent in moderate to vigorous physical activity for one week (unpublished data).The present study aims to show a benefit of an adapted physical activity program on BMD in children and adolescents with IBD.

Conditions

Crohn Disease; Chronic; Colitis (Noninfective); Crohn's Enteritis; Ulcerative Colitis

Keywords

inflammatory bowel disease; physical activity; bone mineral density; pediatric

Outcome Measures

Primary Outcomes (1)

• Change in total (whole body) Bone Mineral Density

  At 9 months

Secondary Outcomes (8)

• 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

Study Arms (2)

physical activity program

EXPERIMENTAL

Child with an adapted physical activity program

Other: adapted physical activity

Usual care

OTHER

Other: Usual care

Interventions

Usual care OTHER

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.

Usual care

adapted physical activity OTHER

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.

physical activity program

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (2)

Chu Amiens Picardie

Amiens, France

Location

Hop Jeanne de Flandre Chu Lille

Lille, France

Location

Related Publications (1)

• 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.

  PMID: 32430452 RESULT

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Bronchiolitis Obliterans Syndrome; Colitis; Inflammatory Bowel Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Behavior

Study Officials

• Stéphanie COOPMAN, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 12, 2018
• Study Start: March 2, 2020
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: December 23, 2025

Record last verified: 2021-12

Locations

FR (2)