背景:炎症性肠病(IBD)是胃肠道的慢性疾病,与可能对青少年的身体活动和身体成分产生不利影响的不良健康后果有关。这些影响可能会导致身体素质的变化,与健康相关的结果呈正相关。目的是评估IBD儿科患者与健康相关的身体健康水平,并将这些水平与健康匹配的对照组进行比较。
方法:本试验为双中心病例对照研究。将招募50名患有IBD的儿科患者和50名匹配的健康对照(1:1),和身体健康水平(心肺健康,肌肉力量,速度/敏捷性和灵活性)将被评估。主要结果是心肺健康,将在患有IBD的儿童和青少年与年龄相匹配的健康对照之间进行比较,性别和体重指数类。我们将根据青少年健康心肺健康水平的性别特定截止值,评估两组在其他身体健康因素和成年期心血管风险方面是否存在差异。我们将确定身体健康与IBD特征之间的关系,生活质量和日常体力活动。
背景:这项研究得到了研究伦理委员会的批准(保护委员会,中心-前我,Tours,法国;编号2019-A02651-56),并向国家信息和自由委员会宣布。所有程序将根据1975年赫尔辛基宣言的道德标准进行,2008年修订,以及欧盟的良好临床实践指南。将从年轻人及其父母那里获得书面知情同意书。研究结果将在同行评审的期刊和科学会议上传播,以及社交媒体和IBD家庭支持团体。
背景:NCT04647578。
BACKGROUND: Inflammatory bowel disease (IBD) is a chronic disorder of the gastrointestinal tract, associated with adverse health consequences that may adversely influence physical activity and body composition in youth. These effects may lead to changes in physical fitness, which is positively associated with health-related outcomes. The aim is to assess health-related physical fitness levels in paediatric patients with IBD and to compare these levels with those in healthy matched controls.
METHODS: This trial is a bicentric
case-control study. Fifty paediatric patients with IBD and 50 matched healthy controls will be recruited (1:1), and physical fitness levels (cardiorespiratory fitness, muscular strength, speed/agility and flexibility) will be assessed. The primary outcome is cardiorespiratory fitness, which will be compared between children and adolescents with IBD and healthy controls matched for age, sex and body mass index class. We will assess whether the two groups differ with respect to other physical fitness components and cardiovascular risk in adulthood according to sex-specific cut-offs for a healthy cardiorespiratory fitness level in adolescents. We will identify relationships between physical fitness and characteristics of IBD, quality of life and daily physical activity.
BACKGROUND: This study was approved by the Research Ethics Committee (Comité de Protection des Personnes, Centre-Ouest I, Tours, France; No 2019-A02651-56) and was declared to the Commission Nationale de l\'Informatique et des Libertés. All procedures will be performed according to the ethical standards of the 1975 Declaration of Helsinki, as revised in 2008, and the European Union\'s Guidelines for Good Clinical Practice. Written informed consent will be obtained from the youths and their parents. Research findings will be disseminated in peer-reviewed journals and scientific meetings, as well as in social media and IBD family support groups.
BACKGROUND: NCT04647578.