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OpenTrials
Completed

NCT Number: NCT04647578

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

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.

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Key information

Conditions

Crohn's Enteritis Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Granulomatous Colitis Granulomatous Enteritis Ileocolitis Inflammatory Bowel Diseases Intestinal Diseases Proctitis Proctocolitis Rectal Diseases Sigmoid Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GT3X Actigraph accelerometer.

Device

GT3X Actigraph accelerometer during 7 days

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.

    Time frame: At 7 days

Secondary outcomes

  1. Difference in muscular endurance, strength, speed/agility, flexibility, strength between children and adolescents with IBD and age-, BMI and sex-matched healthy controls

    Time frame: Baseline, at 7 days

  2. Disease activity according to PCDAI scores

    Time frame: Baseline, at 7 days

    (Pediatric Crohn Disease Activity Index)

  3. Disease activity according to PUCAI scores

    Time frame: Baseline, at 7 days

    Pediatric Ulcerative Colitis Activity Index

  4. Percentage of IBD children and adolescents with a cardiovascular risk disease

    Time frame: Baseline, at 7 days

  5. Correlation between quality of life and physical fitness in children and adolescent with IBD

    Time frame: Baseline, at 7 days

  6. Correlation between fatigue and physical fitness in children and adolescent with IBD

    Time frame: Baseline, at 7 days

  7. Correlation between daily physical activity and physical fitness in children and adolescent with IBD

    Time frame: Baseline, at 7 days

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Groupement Interrégional de Recherche Clinique et d'Innovation

Registry information

Acronym: MICI-FIT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 1, 2020
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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