Physical Activity and Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease

Study Overview
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Brief Summary
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This study is an observational study. The purpose of this study is to assess the relationship between bone health and daily physical activity in children and adolescents with inflammatory bowel disease (IBD). Reduced bone mineral density is a common complication in pediatric IBD. Physical activity is an important determinant of health throughout the whole lifespan. Engaging in regular moderate-to-vigorous physical activity has important health benefits. Based on available evidence, the investigators hypothesize that daily moderate-to-vigorous physical activity could improve bone health (ie bone mineral density) in children and adolescents with IBD.

Detailed Description
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To carry out this study, 120 patients (age ≥6 and <18 years at the screening visit) will be enrolled in this observational study. After obtaining the informed consent from the parents and the patient, the followings will be performed: clinical examination by a physician, dual-energy X-ray absorptiometry to assess bone density mineral and body composition, collection of a blood sample to assess the inflammatory status of the IBD patient. The patient will be asked also to fill in a questionnaire in order to assess quality of life. He will wear an accelerometer during 7 consecutive days for assessing daily physical activity in free living conditions. The main objective is to assess the relationship between daily physical activity and bone health in children and adolescents with IBD. The secondary objectives are to assess the relationship between daily physical activity and: 1) body composition and 2): quality of life in IBD children and adolescents. To our knowledge, this study is the first to assess the relationship between bone health and daily physical activity in IBD children and adolescents.

Official Title
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Relationship Between Physical Activity and Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Device: multiple examinations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Boys or girls aged between 6 and 18 years old Chronic, acute or intermittent diseas (other than IBD) that can lead to decreased physical activity (example: fracture, paralysis, blindness ... Patient with IBD diagnosed since at least 6 months Written informed consent obtained by the the parents and the patient To have a health insurance Exclusion Criteria: Acute intercurrent events (less than 15 days) at the inclusion day leading to decreased physical activity according to the investigator judgment (fracture(s), recent arthritis, perineal lesions, severe skin lesions) Patient refusing to participate to the study One of the child's parents refusing to participate to the study Lack of adherence foreseeable Participation to another study Pregnant girls Under a justice protect measure

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>follow up of patients (children and adolescent) with inflammatory bowel disease in looking for the relationship between the bone mineral density and physical activity. | Device: multiple examinations<br>* biological,clinical, X-ray, DXA, accelerometry assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual energy-ray absorptiometry (bone mineral density) | We assess the bone mineral density with the Dual energy-ray absorptiometry method at the visit 2 corresponding at 3 weeks after the visit 1 | At 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual energy-ray absorptiometry (Fat Mass) | We assess the Fat Mass with the Dual energy-ray absorptiometry method at the visit 2 corresponding at 3 weeks after the visit 1 | At 3 weeks | 
| Dual energy-ray absorptiometry (Fat Free Mass) | We assess the Fat Free Mass with the Dual energy-ray absorptiometry method at the visit 2 corresponding at 3 weeks after the visit 1 | At 3 weeks | 
| Accelerometry ( Physical Activity) | We assess the Physical Activity with the accelerometry method during 7 consecutive days | At 3 weeks | 
| IMPACT III Questionnaire (quality of life) | We assess the quality of life throughout the IMPACT III questionnaire at the visit 2 corresponding at 3 weeks after the visit 1 | At 3 weeks | 
| PedsQL Questionnaire (quality of life) | We assess the quality of life throughout the PedsQL questionnaire at the visit 2 corresponding at 3 weeks after the visit 1 | At 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone health, Pediatrics, Physical activity, Bone