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临床试验/NCT04650464
NCT04650464已完成不适用

Cardiopulmonary Fitness in Children With Asthma Versus Healthy Children : VO2 Asthma

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 446 人开始时间: 2010年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
446
试验地点
1
主要终点
Comparison cardiopulmonary fitness in children with asthma versus healthy children

研究概览

简要总结

Asthma is the most common chronic disease in children worldwide. Asthma is characterised by a chronic inflammatory disorder of the airways,episodes of wheezing, breathlessness, chest tightness and coughing. There is a large variability of asthma prevalence between countries from 11 to 15% for children in developed countries.

Asthma may limit the patient's ability to be physically active and can lead to a sedentary lifestyle and affect patients' quality of life. Indeed, long-term goal of asthma management as any chronic disease is to control symptoms in order to ensure a normal quality of life to children with asthma In 1980, the World Health Organization stated that functional capacity explorations best reflect the impact of a chronic disease on the quality of life. Indeed, cardiopulmonary exercise test (CPET) has become the "gold standard" in functional evaluation of cardiorespiratory diseases in adults gradually extended to children. Physical fitness is evaluated by maximal oxygen uptake "VO2 max" during a CPET. CPET also allows to determine possible limiting factors (cardiac limitation, ventilatory limitation, muscular deconditioning) responsible for a lower VO2max.

There is actually contradictory evidence regarding the aerobic fitness levels of asthmatic children and it remains unclear whether significant differences exist between asthmatic children and their non-asthmatic counterparts. Few studies suggest ventilatory exercise limitations linked to the severity of bronchial obstruction whether others put in light the impact of muscular deconditioning in the asthmatic population.

In this context, the investigators aimed to compare the cardiopulmonary fitness of children with asthma with that of age-adjusted and gender-adjusted controls. The investigators also intended to identify clinical characteristics associated with VO2max in this population.

详细描述

This retrospective study was carried out from November 2010 to September 2015 for control children (already published PMID: 29170358) : and January 2015 to December 2019 for asthmatic children.

CPET were realised in 2 paediatric CPET laboratories (centre 1: Montpellier University Hospital, France; centre 2: Paediatric Cardiology and Rehabilitation Centre, Institut-Saint-Pierre, Palavas-Les-Flots, France).

Children aged 5 to 18 years old were recruited in one of the 2 CPET laboratories.

Two groups were identified: children with asthma and the control children.

  1. The asthma group consisted of children followed for asthma by any pediatrician or pulmonologist and referred to one of the 2 CPET laboratories. The following clinical data were collected : gender, weight, height, treatments to deduce treatment level (GINA step), associated pathologies, activity level, symptoms during exercice
  2. The control group consisted of children referred for a non-severe functional symptom linked to exercise (murmur, palpitation, or dyspnoea) or for a medical sports certificate. These children were classified in the control group only after a completely normal check-up, including physical examination, electrocardiogram, echocardiography, and spirometry. Children with any chronic disease, medical condition (cardiac, neurologic, respiratory, muscular, or renal), or medical treatment and those requiring any further specialized medical consultation were not eligible. The clinical data collected concerned gender, weight, height.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Comparison cardiopulmonary fitness in children with asthma versus healthy children

时间窗: 1 day

Comparison VO2max in children with asthma versus healthy children.

次要结局

  • Variation of VO2max in asthmatic children(1 day)
  • Comparison of others CPET in children(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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