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

NCT ID: NCT04647578

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-07-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Child with IBD

GT3X Actigraph accelerometer.

Intervention Type: DEVICE

GT3X Actigraph accelerometer during 7 days

Healthy child witnesses

No interventions assigned to this group

Interventions

GT3X Actigraph accelerometer.

GT3X Actigraph accelerometer during 7 days

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Groupement Interrégional de Recherche Clinique et d'Innovation

OTHER

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominique TURCK, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hop Jeanne de Flandre Chu Lille

Lille, , France

Countries

France

Central Contacts

Dominique TURCK, MD,PhD

Role: CONTACT

dominique.turck@chru-lille.fr

0320445962 ext. +33

Laurent Beghin, PhD

Role: CONTACT

DRS@chru-lille.fr

03 20 44 59 62 ext. +33

References

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.

Reference Type: DERIVED

PMID: 36220315 (View on PubMed)

Other Identifiers

2019-A02651-56

Identifier Type: OTHER

Identifier Source: secondary_id

2019_03

Identifier Type: -

Identifier Source: org_study_id