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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pedro Dal Lago, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier:
NCT01643421
First received: July 10, 2012
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Improvement of Functional Capacity.
Improvement of Quality of Life.
Improvement of Cardiovascular Autonomic Control.
 Other: Deep inspiration and positive expiratory airway pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of a Program of Deep Inspiration Combined to Expiratory Positive Airway in Quality of Life and Heart Rate Variability

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of Health Science of Porto Alegre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    The quality of life will be measure by a specific questionnaire for this population 5 weeks apart.


Secondary Outcome Measures:
  • The effect of deep inspiration and positive expiratory airway pressure in respiratory function in adults with severe asthma. [ Time Frame: Change in respiratory function at 5 week ] [ Designated as safety issue: Yes ]
    The respiratory function will be measure by spirometry 5 weeks apart.

  • The effect of deep inspiration and positive expiratory airway pressure in heart rate variability in adults with severe asthma. [ Time Frame: Change in heart rate variability at 5 week ] [ Designated as safety issue: Yes ]
    The heart rate variability will be measure by the acquisition of electrocardiogram signal 5 weeks apart.

  • The effect of deep inspiration and positive expiratory airway pressure in exercise tolerance in adults with severe asthma. [ Time Frame: Change in exercise tolerance at 5 week ] [ Designated as safety issue: Yes ]
    The exercise tolerance will be measure by 6 minute walk test 5 weeks apart.


Estimated Enrollment: 13
Study Start Date: January 2011
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Control

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643421

Locations
Brazil
Pedro Dal Lago
Porto Alegre, RS, Brazil
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
  More Information

No publications provided

Responsible Party: Pedro Dal Lago, Professor, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT01643421     History of Changes
Other Study ID Numbers: II+EPAP
Study First Received: July 10, 2012
Last Updated: July 16, 2012
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013