NIV Application in the Treatment of Asthmatic Children

NCT ID: NCT02939625

Last Updated: 2017-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-12-31

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.

Conditions

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Asthma Child Bronchial Spasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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muscle training

participants will breathing exercises for 20 min, then 40 min training with Threshold IMT therapy will be held in 7 sessions

Group Type ACTIVE_COMPARATOR

muscle training

Intervention Type DEVICE

Continue Positive Airway Pressure

Intervention Type DEVICE

bilevel positive airway pressure

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

muscle training

Intervention Type DEVICE

Continue Positive Airway Pressure

Intervention Type DEVICE

bilevel positive airway pressure

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

muscle training

Intervention Type DEVICE

Continue Positive Airway Pressure

Intervention Type DEVICE

bilevel positive airway pressure

Intervention Type DEVICE

Interventions

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muscle training

Intervention Type DEVICE

Continue Positive Airway Pressure

Intervention Type DEVICE

bilevel positive airway pressure

Intervention Type DEVICE

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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Daysi Tobelem

Md

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maisi David Cabral

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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David MMC, Gomes ELFD, Mello MC, Costa D. Noninvasive ventilation and respiratory physical therapy reduce exercise-induced bronchospasm and pulmonary inflammation in children with asthma: randomized clinical trial. Ther Adv Respir Dis. 2018 Jan-Dec;12:1753466618777723. doi: 10.1177/1753466618777723.

Reference Type DERIVED
PMID: 29865929 (View on PubMed)

Other Identifiers

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Rehabilitation in asthma

Identifier Type: -

Identifier Source: org_study_id