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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: GT3X Actigraph accelerometer.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Child with IBD<br> | Device: GT3X Actigraph accelerometer.<br>* GT3X Actigraph accelerometer during 7 days<br>|
| Healthy child witnesses<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, IBD, physical fitness