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

University Hospital, Lille

Status: Completed

Conditions: Inflammatory Bowel Disease

Treatments: Device: multiple examinations

Study type: Observational

Funder types: Other

Identifiers

NCT02341742

2013_69

2014-A00685-42 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

84 participants in 1 patient group

Patients

Description:

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

Treatment:

Device: multiple examinations