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Clinical Trials/NCT01643421
NCT01643421CompletedNot Applicable

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

Federal University of Health Science of Porto Alegre1 site in 1 country14 target enrollmentStarted: January 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
14
Locations
1
Primary Endpoint
The effect of deep inspiration and positive expiratory airway pressure in quality of life in adults with severe asthma

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Deep inspiration and expiratory positive airway pressure

Experimental

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

Intervention: Deep inspiration and positive expiratory airway pressure (Other)

Control

No Intervention

Outcomes

Primary Outcomes

The effect of deep inspiration and positive expiratory airway pressure in quality of life in adults with severe asthma

Time Frame: Change in quality of life at 5 week

The quality of life will be measure by a specific questionnaire for this population 5 weeks apart.

Secondary Outcomes

  • The effect of deep inspiration and positive expiratory airway pressure in respiratory function in adults with severe asthma.(Change in respiratory function at 5 week)
  • The effect of deep inspiration and positive expiratory airway pressure in exercise tolerance in adults with severe asthma.(Change in exercise tolerance at 5 week)
  • The effect of deep inspiration and positive expiratory airway pressure in heart rate variability in adults with severe asthma.(Change in heart rate variability at 5 week)

Investigators

Sponsor
Federal University of Health Science of Porto Alegre
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pedro Dal Lago

Professor

Federal University of Health Science of Porto Alegre

Study Sites (1)

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