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

Not yet recruiting

• Conditions: Crohn's Enteritis; Colitis, Ulcerative; Granulomatous Colitis; Proctocolitis; Crohn Disease; Granulomatous Enteritis; Inflammatory Bowel Diseases; Ileocolitis
• Interventions: Device: GT3X Actigraph accelerometer.

• Registration Number: NCT04647578
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-07
• Study Start: 2022-12
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Child with IBD	GT3X Actigraph accelerometer.	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Percentage of IBD children and adolescents with a cardiovascular risk disease	Baseline, at 7 days
Disease activity according to PCDAI scores	Baseline, at 7 days	(Pediatric Crohn Disease Activity Index)
Disease activity according to PUCAI scores	Baseline, at 7 days	Pediatric Ulcerative Colitis Activity Index
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
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

Trial Locations

Locations (1)

Hop Jeanne de Flandre Chu Lille; 🇫🇷 Lille, France