NIV Application in the Treatment of Asthmatic Children

Study Overview
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Brief Summary
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Asthma is characterized by recurrent episodes of bronchospasm, bronchial hyperresponsiveness and chronic airway inflammation and pharmacological treatment for this condition is done with bronchodilators and anti-inflammatory.

Detailed Description
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Pharmacologic therapy has clinical efficacy in the control, but the patient often does not adhere adequately. There is need for further research into non-pharmacological therapies for clinical asthma control and in turn the use of CPAP and bilevel pressure in the airways has shown beneficial effects on autonomic modulation and bronchial responsiveness leading to the hypothesis that these therapies also have effects on the BIE.The aim of this study is to evaluate the effect of these non-pharmacological therapies in several variables and especially the BIE.

Official Title
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Effects of Continuous and Bilevel Positive Airway Pressure During Exercise-induced Bronchoconstriction in Asthmatic Children: Controlled Clinical Trial, Randomized

Conditions
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Asthma, Child, Bronchial Spasm

Intervention / Treatment
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* Device: muscle training
* Device: Continue Positive Airway Pressure
* Device: bilevel positive airway pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 5:11 years; Both sexes; Do not be included in any regular physical activity program; Having a diagnosis of asthma, according to the Global Initiative for Asthma (GINA); Not having received Theophylline or aminophylline and oral corticosteroids in the last 30 days; not have presented respiratory infection in the last two months; Signature of IC Exclusion Criteria: Have done inhaled bronchodilator in less than 12 hours before the assessment; Inability to understand or perform any of the tests, due to physical and mental limitations; Intolerance proposed activities; Have heart disease inflammatory, congenital or ischemic origin; Being in the presence of any infectious process with fever.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: muscle training<br>participants will breathing exercises for 20 min, then 40 min training with Threshold IMT therapy will be held in 7 sessions | Device: muscle training<br> <br> Device: Continue Positive Airway Pressure<br> <br> Device: bilevel positive airway pressure<br> <br> |
| Active Comparator: bilevel positive airway pressure<br>participants will breathing exercises for 20 min, then 40 min bilevel (IPAP and EPAP 12 = 8 cm H2O), the therapy will be held in 7 sessions | Device: muscle training<br> <br> Device: Continue Positive Airway Pressure<br> <br> Device: bilevel positive airway pressure<br> <br> |
| Active Comparator: Continue Positive Airway Pressure<br>participants will breathing exercises for 20 min, then 40 min CPAP (8 cm H2O) therapy will be held in 7 sessions | Device: muscle training<br> <br> Device: Continue Positive Airway Pressure<br> <br> Device: bilevel positive airway pressure<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled nitric oxide (part per billion) | assess the degree of inflammation of the respiratory system using expired fraction of nitric oxide before and after the different protocols applied | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate Variability |  | 20 minutes | 
| manovacuometry |  | 10 minutes | 
| Pulmonary function test |  | 20 minutes | 
| bioelectrical impedance |  | 10 minutes | 
| Bronchoconstriction induced by stress |  | 30 minutes |