Physical Fitness Levels in Children and Adolescents With Chronic Inflammatory Bowel Disease (CIBD): Crohn's Disease, Ulcerative Colitis, Chronic Unclassified Colitis (MICI-FIT)

Inflammatory bowel diseases (IBDs), including Crohn's disease (CD), ulcerative colitis (UC) and IBD-unclassified (IBD-U), are characterised by chronic inflammation of the gastrointestinal tract. Over the past 50 years, the incidence of IBD has increased globally, with the highest increase in industrialised countries. During the last 25 years, the incidence of IBD has increased dramatically among teenagers in northern France, with an increase of 126% and 156% for CD and UC, respectively.

Physical fitness is a set of attributes related to a person's ability to perform physical activities that require aerobic capacity, endurance, strength or flexibility and is determined by a combination of regular physical activity and genetically inherited ability. Physical fitness, widely recognised as an important health determinant, plays an important role in growth and development. Due to the evidence-based importance of physical fitness for young people's health status, attention should be paid to the assessment of physical fitness at these ages and whatever the health status.

At this time, there is no study on the assessment of physical fitness in IBD pediatric patient.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Ileocolitis; Proctocolitis; Granulomatous Colitis; Crohn's Enteritis; Granulomatous Enteritis
• Intervention / Treatment: Device: GT3X Actigraph accelerometer.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Dominique TURCK, MD,PhD; Phone Number: +33 0320445962; Email: dominique.turck@chru-lille.fr
• Study Contact Backup: Name: Laurent Beghin, PhD; Phone Number: +33 03 20 44 59 62; Email: DRS@chru-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy children and adolescents with IBD (Crohn's disease, ulcerative colitis and chronic ulcerative colitis).

Description

Inclusion Criteria:

• For children with IBD:
• boy or girl aged 10 to 17 years old when signing the consent.
• obtain the consent of participation of the child and the signed inform consent of the two parents or a legal representative.
• Patient benefiting from health care- has IBD (Crohn's disease, ulcerative colitis and unclassified chronic colitis) for at least 6 months.
• Contactable by phone

For healthy controls:

• Patient without IBD
• Boy or girl aged 10 to 17 years old when signing the consent.
• obtain the consent of participation of the child and the signed inform consent of the two parents or a legal representative.
• Patient benefiting from health care

Exclusion Criteria:

• For children with IBD:
• Acute intercurrent events at the time of inclusion which may lead to a decrease in physical fitness and activity, according to the judgment of the investigator (fractures, recent arthritis, ano-perineal lesions, severe dermatological lesions).
• Patients with a disease a mild activity (PCDAI score > 30 for children with Crohn disease and PUCAI > 35 for children with ulcerative colitis.
• Chronic, acute or intermittent diseases (other than IBD) that may lead to a decrease in physical activity (Example: fracture, paralysis, blindness ...).
• Refusal of the child's participation in the protocol.
• Refusal of one of the child's parents to participate in the protocol.
• Participation in another interventional study.
• Pregnant or lactating women.
• Patient under protection of justice.

For healthy controls:

• Chronic, acute or intermittent diseases (other than IBD) that may lead to a decrease in physical fitness and activity (Example: fracture, paralysis, blindness ...).
• Refusal of the child's participation in the protocol.
• Refusal of one of the child's parents to participate in the protocol.
• Participation in another interventional study.
• Pregnant or lactating women.
• Patient under protection of justice.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Child with IBD	Device: GT3X Actigraph accelerometer.; GT3X Actigraph accelerometer during 7 days
Healthy child witnesses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in cardiorespiratory fitness (expressed in ml/kg/min) between children and adolescents with IBD and age-, BMI and sex-matched healthy controls.	At 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in muscular endurance, strength, speed/agility, flexibility, strength between children and adolescents with IBD and age-, BMI and sex-matched healthy controls		Baseline, at 7 days
Disease activity according to PCDAI scores	(Pediatric Crohn Disease Activity Index)	Baseline, at 7 days
Disease activity according to PUCAI scores	Pediatric Ulcerative Colitis Activity Index	Baseline, at 7 days
Percentage of IBD children and adolescents with a cardiovascular risk disease		Baseline, at 7 days
Correlation between quality of life and physical fitness in children and adolescent with IBD		Baseline, at 7 days
Correlation between fatigue and physical fitness in children and adolescent with IBD		Baseline, at 7 days
Correlation between daily physical activity and physical fitness in children and adolescent with IBD		Baseline, at 7 days

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation

Publications and helpful links

General Publications

• Vanhelst J, Beghin L, Coopman S, Labreuche J, Djeddi D, Gottrand F, Turck D, Ley D. Physical fitness in children and adolescents with inflammatory bowel disease: protocol for a case-control study. BMJ Open. 2022 Oct 11;12(10):e063403. doi: 10.1136/bmjopen-2022-063403.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2022
• Primary Completion (ANTICIPATED): July 1, 2024
• Study Completion (ANTICIPATED): July 1, 2024

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (ACTUAL): December 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Pediatric; IBD; physical fitness
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Rectal Diseases; Sigmoid Diseases; Proctitis; Ulcer; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Enteritis; Colitis; Colitis, Ulcerative; Proctocolitis
• Other Study ID Numbers: 2019_03; 2019-A02651-56 (OTHER: ID-RCB number,ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data are available upon reasonable request. Data will be made available following the conclusion of the project's period of funding.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No