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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02341742
Acronym
PHYSICOSMICI
Enrollment
84
Registered
2015-01-19
Start date
2014-10-01
Completion date
2017-12-01
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Keywords

Physical activity, Bone health, Pediatrics, Bone

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.

Interventions

DEVICEmultiple examinations

biological,clinical, X-ray, DXA, accelerometry assessment

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dual energy-ray absorptiometry (bone mineral density)At 3 weeksWe 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

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORDominique TURCK, MD, PhD

University Hospital, Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026