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

NCT04647578 | Completed

• 2 other identifiers: 2019_032019-A02651-56
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn Disease; Colitis, Ulcerative; Granulomatous Enteritis; Granulomatous Colitis; Ileocolitis; Proctocolitis; Crohn's Enteritis; Inflammatory Bowel Diseases

Keywords

Pediatric; IBD; physical fitness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  Baseline, at 7 days

• Disease activity according to PUCAI scores

  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

Study Arms (2)

Child with IBD

Device: GT3X Actigraph accelerometer.

Healthy child witnesses

Interventions

GT3X Actigraph accelerometer. DEVICE

GT3X Actigraph accelerometer during 7 days

Child with IBD

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• For children with IBD:
• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Groupement Interrégional de Recherche Clinique et d'Innovation: collaborator

Study Sites (1)

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Location

Related Publications (1)

• 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.

  PMID: 36220315 RESULT

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Colitis, Ulcerative; Proctocolitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Proctitis; Sigmoid Diseases; Rectal Diseases

Study Officials

• Dominique TURCK, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 1, 2020
• Study Start: September 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 21, 2026

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)