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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Lea Bentur, MD
- 電話番号：+97244360
- メール：l_bentur@rambam.health.gov.il
研究連絡先のバックアップ
- 名前：Ronen Bar-Yoseph, MD
- 電話番号：+97247774360
- メール：r_bar-yoseph@rambam.health.gov.il
研究場所
-
-
-
Haifa、イスラエル
- 募集
- Rambam Medical Center
-
コンタクト：
- Ronen Bar-Yoseph, MD
- 電話番号：+97247774360
- メール：r_bar-yoseph@rambam.health.gov.il
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Primary end point
時間枠：15 minutes
|
Maximum drop of forced expiratory volume in one second - (FEV1) after exercise challenge test with and without Nose clip.
|
15 minutes
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Secondary end point
時間枠：15 minutes
|
Forced expiratory volume in one second - (FEV1) improvement after bronchodilators during exercise challenge test with and without Nose clip
|
15 minutes
|
協力者と研究者
捜査官
- 主任研究者：Lea Bentur, MD、Rambam Medical Center Haifa, Israel.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。