Clinical trial NCT03774329: Impact of a Physical Activity Program on Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn's Enteritis
Crohn Disease
Ulcerative Colitis
Chronic; Colitis (Noninfective)
Keywords: inflammatory bowel disease
physical activity
bone mineral density
pediatric
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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correlation between BMD in IBD patients and time spent in moderate to vigorous physical activity for one week (unpublished data).The present study aims to show a benefit of an adapted physical activity program on BMD in children and adolescents with IBD.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in total (whole body) Bone Mineral Density
timeFrame: At 9 months
Secondary outcomes:
measure: Change in vertebral BMD
timeFrame: At 9 months
measure: Change in femoral body BMD
timeFrame: At 9 months
measure: Change in time spent (minutes / day) in moderate to vigorous physical activity measured by accelerometry for 7 days
timeFrame: At 9 months
measure: Change in in fat mass measured by two-photon absorptiometry (%)
timeFrame: At 9 months
measure: Change in lean mass measured by two-photon absorptiometry (kg)
timeFrame: At 9 months
measure: Change IMPACT score III
timeFrame: At 9 months
measure: Change in pediatrics crohn's disease activity index or pediatric ulcerative colitis activity index
timeFrame: At 9 months
measure: Change in biologic inflammatory parameters by decrease or increase C-reactive protein
timeFrame: At 9 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens Picardie
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Stéphanie COOPMAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.