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

Completed

• Conditions: Inflammatory Bowel Disease
• Interventions: Device: multiple examinations

• Registration Number: NCT02341742
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-16
• Study First Posted: 2015-01-19
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	multiple examinations	follow up of patients (children and adolescent) with inflammatory bowel disease in looking for the relationship between the bone mineral density and physical activity.

Primary Outcome Measures

Name	Time	Method
Dual energy-ray absorptiometry (bone mineral density)	At 3 weeks	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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Centre hospitalier; 🇫🇷 Béthune, France

Centre Hospitalier St Vincent; 🇫🇷 Lille, France

Clinical Investigation Center; 🇫🇷 Lille, Nord, France

Centre Hospitalier; 🇫🇷 Roubaix, France

Chu Amiens-Picardie - Site Sud; 🇫🇷 Amiens, France