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

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Disease
• Intervention / Treatment: Device: multiple examinations

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.

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • Chu Amiens-Picardie - Site Sud
  • Arras, France
    • Centre Hospitalier
  • Béthune, France
    • Centre Hospitalier
  • Lens, France
    • Centre Hospitalier
  • Lille, France
    • Centre Hospitalier St Vincent
  • Roubaix, France
    • Centre Hospitalier
  • Nord
    • Lille, Nord, France, 59037
      • Clinical Investigation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children and Adolescents With Inflammatory Bowel Disease: Crohn´s disease and Ulcerative colitis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; follow up of patients (children and adolescent) with inflammatory bowel disease in looking for the relationship between the bone mineral density and physical activity.	Device: multiple examinations; biological,clinical, X-ray, DXA, accelerometry assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Accelerometry ( Physical Activity)	We assess the Physical Activity with the accelerometry method during 7 consecutive days	At 3 weeks
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Dominique TURCK, MD, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 7, 2015
• First Submitted That Met QC Criteria: January 16, 2015
• First Posted (Estimate): January 19, 2015

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Physical activity; Pediatrics; Bone; Bone health
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 2013_69; 2014-A00685-42 (Other Identifier: ID-RCB number, ANSM)