Effect of Mouth Breathing on Exercise Induced Bronchoconstriction.
The Effect of Mouth Breathing on Exercise Induced Bronchoconstriction in Children.
Introduction: Exercise induced bronchoconstriction (EIB) is a common finding in the pediatric population with and without asthma. EIB is suspected with a drop of 10-15% in Forced expiratory volume in the 1st second (FEV1) during exercise challenge test (ECT). Some researchers assume that oral breathing, in several mechanisms, increase hyper-responsiveness of the airways.
Aim: Asses the effect of a nose clip and allergic rhinitis in EIB. Hypothesis: The use of a nose clip in exercise challenges will increase the rate of positive tests. However, we assume that children with symptomatic allergic rhinitis will not demonstrate similar trends.
Methods: A prospective, single center cohort study in a pediatric pulmonology institute, at Ruth's children hospital, Rambam medical center, Haifa, Israel. Children referred for ECT will be registered to the study and will be evaluated in two separate visits. Visit 1 - ECT with a nose clip and visit 2 - ECT without a nose clip. Demographic and clinical data and measurements of serial vital signs, exercise data and lung functions will be taken, as well as Total Nasal Symptoms Score (TNSS) and Asthma Control Test (ACT) questionnaires.
研究概览
详细说明
Introduction: Exercise induced bronchoconstriction (EIB) is a common finding in the pediatric population with and without asthma. EIB is evaluated with serial measurements of lung functions during exercise protocol. EIB is suspected with a drop of 10-15% in Forced expiratory volume in the 1st second (FEV1) during exercise challenge test (ECT). Some researchers assume that oral breathing, in several mechanisms, increase hyper-responsiveness of the airways.
Aim: Asses the effect of a nose clip and allergic rhinitis in exercise induced bronchoconstriction.
Hypothesis: The use of a nose clip in exercise challenges will increase the rate of positive tests. However, we assume that children with symptomatic allergic rhinitis will not demonstrate similar trends.
Methods: A prospective, single center cohort study in a pediatric pulmonology institute, at Ruth's children hospital, Rambam medical center, Haifa, Israel, during 2020-2021. Children referred for ECT will be registered to the study after signing an informed consent and will be evaluated in two separate visits. Visit 1 - ECT with a nose clip and visit 2 - ECT without a nose clip. ECT will be conducted according to the institute protocol, based on American Thoracic Society (ATS) guidelines. Demographic and clinical data and measurements of serial vital signs, exercise data and lung functions will be taken, as well as Total Nasal Symptoms Score (TNSS) and Asthma Control Test (ACT) questionnaires.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Lea Bentur, MD
- 电话号码：+97244360
- 邮箱：l_bentur@rambam.health.gov.il
研究联系人备份
- 姓名：Ronen Bar-Yoseph, MD
- 电话号码：+97247774360
- 邮箱：r_bar-yoseph@rambam.health.gov.il
学习地点
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Haifa、以色列
- 招聘中
- Rambam Medical Center
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接触：
- Ronen Bar-Yoseph, MD
- 电话号码：+97247774360
- 邮箱：r_bar-yoseph@rambam.health.gov.il
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Exercise challenge test as part of exercise induced asthma evaluation.
- Age 6-18 years.
Exclusion Criteria:
- Other chronic lung disease
- Significant background illness
- Severe asthma exacerbation or systemic steroids - last 2 months
- Persistent use of inhaled steroids - last 2 weeks
- Use of short acting bronchodilators - last 24 hours.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Exercise challenge test (ECT) with and without nose clip (NC).
All participants after receiving informed consent were invited for 2 visits. Visit 1 - ECT performed with NC. Visit 2 - ECT performed without NC. Demographic and clinical data and measurements of vital signs, exercise data and lung functions were recorded. ECT completed on treadmill. Questionnaires: Total Nasal Symptom Score (TNSS 0-6). Asthma Control Test (ACT 5-25) . Positive ECT = drop in FEV1 >12% from baseline |
Baseline demographic, clinical and rest lung functions were recorded.
ECT was performed on treadmill according to fixed protocol.
Clinical data during ECT was recorded.
(visit 1- performed with nose clip, visit 2- performed without nose clip).
Lung function were measured and recorded at fixed time after ECT and after bronchodilator administration.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Primary end point
大体时间：15 minutes
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Maximum drop of forced expiratory volume in one second - (FEV1) after exercise challenge test with and without Nose clip.
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15 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Secondary end point
大体时间：15 minutes
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Forced expiratory volume in one second - (FEV1) improvement after bronchodilators during exercise challenge test with and without Nose clip
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15 minutes
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合作者和调查者
调查人员
- 首席研究员：Lea Bentur, MD、Rambam Medical Center Haifa, Israel.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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