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

Improvement of Cardiovascular Autonomic Control. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643421
• Other study ID #: II+EPAP
• Status: Completed
• Phase: N/A
• First received: July 10, 2012
• Last updated: August 7, 2014
• Start date: January 2011
• Est. completion date: July 2012

Study information

• Verified date: August 2014
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Brazil	Pedro Dal Lago	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes