Physical Fitness Levels in Children and Adolescents With Chronic Inflammatory Bowel Disease (CIBD): Crohn's Disease, Ulcerative Colitis, Chronic Unclassified Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Difference in cardiorespiratory fitness (expressed in ml/kg/min) between children and adolescents with IBD and age-, BMI and sex-matched healthy controls.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Child with IBD
干预措施: GT3X Actigraph accelerometer. (Device)
Healthy child witnesses
结局指标
主要结局
Difference in cardiorespiratory fitness (expressed in ml/kg/min) between children and adolescents with IBD and age-, BMI and sex-matched healthy controls.
时间窗: At 7 days
次要结局
- 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(Baseline, at 7 days)
- Disease activity according to PUCAI scores(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)