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

NCT01643421 | Completed DMC

• 1 other identifier: II+EPAP
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 heart rate variability in adults with severe asthma.

  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.

  Change in exercise tolerance at 5 week

Study Arms (2)

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.

Other: Deep inspiration and positive expiratory airway pressure

Control

NO INTERVENTION

Interventions

Deep inspiration and positive expiratory airway pressure OTHER

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

Deep inspiration and expiratory positive airway pressure

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20 and 80
• Severe asthma

You may not qualify if:

• Disagreement with consent form
• Other respiratory disease
• Acute severe asthma
• Pregnancy or breastfeeding
• Current smoking
• Lack of capable of conducting the study visits

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Pedro Dal Lago

Porto Alegre, Rio Grande do Sul, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 18, 2012
• Study Start: January 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 11, 2014

Record last verified: 2014-08

Locations

BR (1)