跳至主要内容
临床试验/NCT03376880
NCT03376880招募中不适用

Respiratory Effects of Obesity in Children

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2017年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
96
试验地点
1
主要终点
Pulmonary Function: Lung Volumes

研究概览

简要总结

In obese children, excess fat on the thorax exerts an unfavorable burden on the respiratory system, particularly during exercise; however, it is unclear if this burden reduces exercise tolerance, provokes dyspnea on exertion, or contributes to respiratory symptoms that could be misdiagnosed as asthma, placing obese children at risk of unnecessary treatment and potentially a reluctance to exercise explaining reports of low physical activity and fitness levels, which are counterproductive to weight loss. The investigators will examine the respiratory effects of obesity in prepubescent boys and girls, including those with respiratory symptoms misdiagnosed as asthma, before and after 1) a program of weight loss and regular exercise and 2) continued weight gain as compared with prepubescent normal weight boys and girls before and after 1 year. These results will have broad and immediate clinical impact on the care of obese children, especially those with respiratory symptoms misdiagnosed as asthma, and the results could alter interventional approaches for preventing and treating childhood obesity.

详细描述

In obese children, excess fat exerts an unfavorable burden on the respiratory system, particularly during exercise, potentially reducing exercise tolerance and leading to DOE (dyspnea on exertion), which could explain reports of low physical activity and fitness levels in obese children. The investigators propose that most of the respiratory effects in obese children are the result of low lung volume breathing, i.e., a reduction in functional residual capacity (FRC) at rest, and end-expiratory lung volume (EELV) during exercise.

The overall objective of this application is to investigate the respiratory effects of obesity in prepubescent children, including obese children with respiratory symptoms misdiagnosed as asthma, before and after 1) a program of weight loss and regular exercise and 2) continued weight gain as compared with normal weight children before and after 1 yr. The investigative approach will be to examine respiratory function, exercise tolerance, and dyspnea on exertion (DOE) in prepubescent obese boys and girls, including those misdiagnosed with asthma (i.e., asthma not confirmed by lung function tests), before and after 1) weight loss (or an equivalent reduction in BMI percentile) and regular exercise and 2) continued weight gain (or an increase in BMI percentile) as compared with prepubescent normal weight boys and girls before and after a control period of 1 yr.

Specific Aims: The following hypotheses will be tested in obese children as compared with normal weight children:

Aim 1) Obesity will decrease respiratory function but to a greater extent in obese children misdiagnosed with asthma as evidenced by altered pulmonary function and breathing mechanics at rest; Aim 2) Obesity will decrease exercise tolerance (as evidenced by peak maximum oxygen uptake (VO2) in ml/min/kg, i.e., physical fitness), but not cardiorespiratory fitness (as evidenced by peak VO2 in % of predicted based on ideal body wt), except in obese children misdiagnosed with asthma where both may be reduced during graded cycle ergometry; Aim 3) Obesity will increase DOE but to a greater extent in obese children misdiagnosed with asthma as evidenced by increased ratings of perceived breathlessness during constant load exercise cycling; and Aim 4) Weight loss and regular exercise will improve respiratory function, exercise tolerance, and DOE in obese children, including those misdiagnosed with asthma, while continued weight gain will worsen respiratory function, exercise tolerance, and DOE in obese children, including those misdiagnosed with asthma, as compared with normal weight children before and after 1 yr.

The long-term objective is to investigate the effects of obesity on respiratory function, exercise tolerance, and DOE, examine obesity-related respiratory symptoms misdiagnosed as asthma in obese children, and provide novel results that could alter interventional approaches for preventing obesity and treating obesity in obese children. Thus, these results will have broad and immediate clinical impact on the care of obese children, especially those with respiratory symptoms misdiagnosed as asthma.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Otherwise healthy with normal lung function; prepubescent (Tanner equal to or less than 3); age and gender specific BMI > 95th percentile, but less than 150% of the 95th percentile based on the CDC standards or age and gender specific BMI between the 16th and 84th percentile based on the Center for Disease Control (CDC) standards; and ability to perform pulmonary and exercise test accurately.

排除标准

  • Children with significant diseases other than obesity or shortness of breath on exertion will be excluded. Subjects participating in regular conditioning-type vigorous exercise two times or more per week will be excluded (i.e., sports training). Children who are non-English speaking will be excluded from the study because the tests performed are very effort dependent, detailed, and require technical communication between the staff and the child.

结局指标

主要结局

Pulmonary Function: Lung Volumes

时间窗: Change from Baseline in difference between nonobese and obese children at 1 yr

Pulmonary function is comprised of several physiological variables but this study will primarily measure Lung Volume: FRC (liters) and TLC (liters)

Dyspnea on Exertion

时间窗: Change from Baseline differences between nonobese and obese children at 1 yr

Dyspnea on Exertion is represented using the Borg Scale which provides Ratings of Perceived Breathlessness (RPB) during constant load exercise cycling. The Borg Scale measures from 0-10, where 0 = no breathlessness and 10 = maximal breathlessness.

Exercise Tolerance - Peak VO2

时间窗: Change from Baseline differences between nonobese and obese children at 1 yr

Exercise Tolerances is represented by several physiological variables but the primary variable is Maximal oxygen uptake (L/min and percent predicted)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tony Babb

PROFESSOR

University of Texas Southwestern Medical Center

研究点 (1)

Loading locations...

相似试验