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

NCT ID: NCT01643421

Last Updated: 2014-08-11

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-07-31

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Deep inspiration and expiratory positive airway pressure

The protocol of deep inspiration combined to expiratory positive airway pressure will be applied in asthmatic subjects.

Group Type EXPERIMENTAL

Deep inspiration and positive expiratory airway pressure

Intervention Type OTHER

It was used a device the combines deep inspiration and positive expiratory airway pressure in asthmatic subjects, for 5 weeks, twice a day.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Deep inspiration and positive expiratory airway pressure

It was used a device the combines deep inspiration and positive expiratory airway pressure in asthmatic subjects, for 5 weeks, twice a day.

Intervention Type OTHER

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Pedro Dal Lago

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pedro Dal Lago

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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II+EPAP

Identifier Type: -

Identifier Source: org_study_id

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