NIV Application in the Treatment of Asthmatic Children

Not Applicable

Completed

• Conditions: Bronchial Spasm; Asthma; Child
• Interventions: Device: muscle training; Device: Continue Positive Airway Pressure; Device: bilevel positive airway pressure

• Registration Number: NCT02939625
• Lead Sponsor: University of Nove de Julho

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-20
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-19
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bilevel positive airway pressure	bilevel positive airway pressure	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
muscle training	muscle training	participants will breathing exercises for 20 min, then 40 min training with Threshold IMT therapy will be held in 7 sessions
muscle training	Continue Positive Airway Pressure	participants will breathing exercises for 20 min, then 40 min training with Threshold IMT therapy will be held in 7 sessions
bilevel positive airway pressure	Continue Positive Airway Pressure	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
Continue Positive Airway Pressure	bilevel positive airway pressure	participants will breathing exercises for 20 min, then 40 min CPAP (8 cm H2O) therapy will be held in 7 sessions
bilevel positive airway pressure	muscle training	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
Continue Positive Airway Pressure	muscle training	participants will breathing exercises for 20 min, then 40 min CPAP (8 cm H2O) therapy will be held in 7 sessions
Continue Positive Airway Pressure	Continue Positive Airway Pressure	participants will breathing exercises for 20 min, then 40 min CPAP (8 cm H2O) therapy will be held in 7 sessions
muscle training	bilevel positive airway pressure	participants will breathing exercises for 20 min, then 40 min training with Threshold IMT therapy will be held in 7 sessions

Primary Outcome Measures

Name	Time	Method
Exhaled nitric oxide (part per billion)	5 minutes	assess the degree of inflammation of the respiratory system using expired fraction of nitric oxide before and after the different protocols applied

Secondary Outcome Measures

Name	Time	Method
Bronchoconstriction induced by stress	30 minutes
Heart Rate Variability	20 minutes
Pulmonary function test	20 minutes
manovacuometry	10 minutes
bioelectrical impedance	10 minutes

Trial Locations

Locations (1)

Maisi David Cabral; 🇧🇷 São Paulo, Brazil