Effect of a Program of Deep Inspiration Combined to Expiratory Positive Airway Pressure in Asthmatic

Study Overview
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Brief Summary
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The purpose of this study is to determine the effects of a deep inspiration combined to expiratory positive airway pressure protocol on respiratory function, quality of life, exercise tolerance and heart rate variability in adults with severe asthma.

Detailed Description
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Asthma is associated with high morbidity and significant mortality. This disease has functional impact on activities of daily living (ADLs) and according to some studies in the United States and Europe, the percentage of asthmatics who have significant restrictions in their ADLs is quite significant. Asthma is characterized as a major public health problem, not only in Brazil but worldwide. Currently there are few studies reporting the effects of a domiciliary program of deep inspiration associated with positive expiratory pressure in the airways of asthmatics. This study aims to analyze the benefits of this program on lung function, quality of life and response to exercise.

Official Title
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Effects of a Program of Deep Inspiration Combined to Expiratory Positive Airway in Quality of Life and Heart Rate Variability

Conditions
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Improvement of Functional Capacity., Improvement of Quality of Life., Improvement of Cardiovascular Autonomic Control.

Intervention / Treatment
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* Other: Deep inspiration and positive expiratory airway pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 and 80 Severe asthma Exclusion Criteria: Disagreement with consent form Other respiratory disease Acute severe asthma Pregnancy or breastfeeding Current smoking Lack of capable of conducting the study visits

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep inspiration and expiratory positive airway pressure<br>The protocol of deep inspiration combined to expiratory positive airway pressure will be applied in asthmatic subjects. | Other: Deep inspiration and positive expiratory airway pressure<br>* It was used a device the combines deep inspiration and positive expiratory airway pressure in asthmatic subjects, for 5 weeks, twice a day.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of deep inspiration and positive expiratory airway pressure in quality of life in adults with severe asthma | The quality of life will be measure by a specific questionnaire for this population 5 weeks apart. | Change in quality of life at 5 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of deep inspiration and positive expiratory airway pressure in respiratory function in adults with severe asthma. | The respiratory function will be measure by spirometry 5 weeks apart. | Change in respiratory function at 5 week | 
| The effect of deep inspiration and positive expiratory airway pressure in heart rate variability in adults with severe asthma. | The heart rate variability will be measure by the acquisition of electrocardiogram signal 5 weeks apart. | Change in heart rate variability at 5 week | 
| The effect of deep inspiration and positive expiratory airway pressure in exercise tolerance in adults with severe asthma. | The exercise tolerance will be measure by 6 minute walk test 5 weeks apart. | Change in exercise tolerance at 5 week |