Clinical Trials Directory

Trials / Completed

CompletedNCT02341742

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
84 (actual)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
6 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEmultiple examinationsbiological,clinical, X-ray, DXA, accelerometry assessment

Timeline

Start date
2014-10-01
Primary completion
2017-12-01
Completion
2017-12-01
First posted
2015-01-19
Last updated
2018-01-30

Locations

7 sites across 1 country: France

Source: ClinicalTrials.gov record NCT02341742. Inclusion in this directory is not an endorsement.