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

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

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.

Study Overview

• Status: Completed
• Conditions: Improvement of Functional Capacity.; Improvement of Quality of Life.; Improvement of Cardiovascular Autonomic Control.
• Intervention / Treatment: Other: Deep inspiration and positive expiratory airway pressure

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil
      • Pedro Dal Lago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Deep inspiration and expiratory positive airway pressure; 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; It was used a device the combines deep inspiration and positive expiratory airway pressure in asthmatic subjects, for 5 weeks, twice a day.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: July 10, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (Estimate): July 18, 2012

Study Record Updates

• Last Update Posted (Estimate): August 11, 2014
• Last Update Submitted That Met QC Criteria: August 7, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: II+EPAP