Clinical trial NCT02341742: Physical Activity and Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease
Official title: Relationship Between Physical Activity and Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Keywords: Physical activity
Bone health
Pediatrics
Bone
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 84
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and Adolescents With Inflammatory Bowel Disease: Crohn´s disease and Ulcerative colitis

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dual energy-ray absorptiometry (bone mineral density)
timeFrame: At 3 weeks
Secondary outcomes:
measure: Dual energy-ray absorptiometry (Fat Mass)
timeFrame: At 3 weeks
measure: Dual energy-ray absorptiometry (Fat Free Mass)
timeFrame: At 3 weeks
measure: Accelerometry ( Physical Activity)
timeFrame: At 3 weeks
measure: IMPACT III Questionnaire (quality of life)
timeFrame: At 3 weeks
measure: PedsQL Questionnaire (quality of life)
timeFrame: At 3 weeks
Other outcomes:
Locations:
city: Lille
country: France
facility: Clinical Investigation Center
state: Nord
city: Amiens
country: France
facility: Chu Amiens-Picardie - Site Sud
city: Arras
country: France
facility: Centre Hospitalier
city: Béthune
country: France
facility: Centre hospitalier
city: Lens
country: France
facility: Centre Hospitalier
city: Lille
country: France
facility: Centre Hospitalier St Vincent
city: Roubaix
country: France
facility: Centre Hospitalier
Study officials:
affiliation: University Hospital, Lille
name: Dominique TURCK, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: