NCT02341742

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 14, 2026

Status Verified

January 1, 2018

Enrollment Period

3.2 years

First QC Date

January 7, 2015

Last Update Submit

May 11, 2026

Conditions

Inflammatory Bowel Disease

Keywords

Physical activityBone healthPediatricsBone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Dual energy-ray absorptiometry (Fat Mass)

    At 3 weeks

  • Dual energy-ray absorptiometry (Fat Free Mass)

    At 3 weeks

  • Accelerometry ( Physical Activity)

    At 3 weeks

  • IMPACT III Questionnaire (quality of life)

    At 3 weeks

  • PedsQL Questionnaire (quality of life)

    At 3 weeks

Study Arms (1)

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

Interventions

multiple examinationsDEVICE

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

Patients

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Clinical Investigation Center

Lille, Nord, 59037, France

Location

Chu Amiens-Picardie - Site Sud

Amiens, France

Location

Centre Hospitalier

Arras, France

Location

Centre hospitalier

Béthune, France

Location

Centre Hospitalier

Lens, France

Location

Centre Hospitalier St Vincent

Lille, France

Location

Centre Hospitalier

Roubaix, France

Location

Related Publications (1)

  • Vanhelst J, Beghin L, Drumez E, Djeddi-Dine D, Tuck D, Coopman S, Gottrand F, Ley D. Validation of the IMPACT-III Questionnaire in French Children With Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2023 Apr 1;76(4):e71-e76. doi: 10.1097/MPG.0000000000003716. Epub 2023 Feb 2.

    PMID: 36735394RESULT

MeSH Terms

Conditions

Inflammatory Bowel DiseasesMotor Activity

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesBehavior

Study Officials

  • Dominique TURCK, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 19, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 14, 2026

Record last verified: 2018-01

Locations

FR(7)