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

Inflammatory Bowel Disease Clinical Trial

— PHYSICOSMICI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341742
• Other study ID #: 2013_69
• Secondary ID: 2014-A00685-42
• Status: Completed
• Phase: N/A
• First received: January 7, 2015
• Last updated: January 29, 2018
• Start date: October 2014
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Device:
• multiple examinations
biological,clinical, X-ray, DXA, accelerometry assessment

Locations

Country	Name	City	State
France	Chu Amiens-Picardie - Site Sud	Amiens
France	Centre Hospitalier	Arras
France	Centre hospitalier	Béthune
France	Centre Hospitalier	Lens
France	Centre Hospitalier St Vincent	Lille
France	Clinical Investigation Center	Lille	Nord
France	Centre Hospitalier	Roubaix

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dual energy-ray absorptiometry (bone mineral density)	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	At 3 weeks
Secondary	Dual energy-ray absorptiometry (Fat Mass)	We assess the Fat Mass with the Dual energy-ray absorptiometry method at the visit 2 corresponding at 3 weeks after the visit 1	At 3 weeks
Secondary	Dual energy-ray absorptiometry (Fat Free Mass)	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	At 3 weeks
Secondary	Accelerometry ( Physical Activity)	We assess the Physical Activity with the accelerometry method during 7 consecutive days	At 3 weeks
Secondary	IMPACT III Questionnaire (quality of life)	We assess the quality of life throughout the IMPACT III questionnaire at the visit 2 corresponding at 3 weeks after the visit 1	At 3 weeks
Secondary	PedsQL Questionnaire (quality of life)	We assess the quality of life throughout the PedsQL questionnaire at the visit 2 corresponding at 3 weeks after the visit 1	At 3 weeks