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

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correlation between BMD in IBD patients and time spent in moderate to vigorous physical activity for one week (unpublished data).The present study aims to show a benefit of an adapted physical activity program on BMD in children and adolescents with IBD.

Official Title
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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

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

Intervention / Treatment
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* Other: Usual care
* Other: adapted physical activity


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: physical activity program<br>Child with an adapted physical activity program | Other: adapted physical activity<br>* 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.<br>|
| Other: Usual care<br> | Other: Usual care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammatory bowel disease, physical activity, bone mineral density, pediatric