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

Crohn Disease Clinical Trial

— MICI-FIT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04647578
• Other study ID #: 2019_03
• Secondary ID: 2019-A02651-56
• Status: Not yet recruiting
• Start date: December 2022
• Est. completion date: July 2024

Study information

• Verified date: September 2022
• Source: University Hospital, Lille
• Contact: Dominique TURCK, MD,PhD
• Phone: 0320445962
• Email: dominique.turck[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Enteritis
• Enteritis
• Granulomatous Colitis
• Granulomatous Enteritis
• Ileocolitis
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Proctocolitis
• Ulcer

Intervention

Device:
• GT3X Actigraph accelerometer.
GT3X Actigraph accelerometer during 7 days

Locations

Country	Name	City	State
France	Hop Jeanne de Flandre Chu Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Groupement Interrégional de Recherche Clinique et d'Innovation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Disease activity according to PCDAI scores	(Pediatric Crohn Disease Activity Index)	Baseline, at 7 days
Secondary	Disease activity according to PUCAI scores	Pediatric Ulcerative Colitis Activity Index	Baseline, at 7 days
Secondary	Percentage of IBD children and adolescents with a cardiovascular risk disease		Baseline, at 7 days
Secondary	Correlation between quality of life and physical fitness in children and adolescent with IBD		Baseline, at 7 days
Secondary	Correlation between fatigue and physical fitness in children and adolescent with IBD		Baseline, at 7 days
Secondary	Correlation between daily physical activity and physical fitness in children and adolescent with IBD		Baseline, at 7 days