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

U

University Hospital, Lille

Status

Not yet enrolling

Conditions

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

Treatments

Device: GT3X Actigraph accelerometer.

Study type

Observational

Funder types

Other

Identifiers

NCT04647578
2019-A02651-56 (Other Identifier)
2019_03

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

10 to 17 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Child with IBD
Treatment:
Device: GT3X Actigraph accelerometer.
Healthy child witnesses

Trial contacts and locations

1

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Central trial contact

Laurent Beghin, PhD; Dominique TURCK, MD,PhD

Data sourced from clinicaltrials.gov

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