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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Lea Bentur, MD
- Numero di telefono: +97244360
- Email: l_bentur@rambam.health.gov.il
Backup dei contatti dello studio
- Nome: Ronen Bar-Yoseph, MD
- Numero di telefono: +97247774360
- Email: r_bar-yoseph@rambam.health.gov.il
Luoghi di studio
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Haifa, Israele
- Reclutamento
- Rambam Medical Center
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Contatto:
- Ronen Bar-Yoseph, MD
- Numero di telefono: +97247774360
- Email: r_bar-yoseph@rambam.health.gov.il
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Primary end point
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Secondary end point
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Lea Bentur, MD, Rambam Medical Center Haifa, Israel.
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 0716-19-RMB
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