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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
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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