Pedro Dal Lago
Porto Alegre, Rio Grande do Sul, Brazil
Completed
NCT Number: NCT01643421
Effect of a Program of Deep Inspiration Combined to Expiratory Positive Airway Pressure in Asthmatic
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.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
20 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Deep inspiration and positive expiratory airway pressure
OtherIt was used a device the combines deep inspiration and positive expiratory airway pressure in asthmatic subjects, for 5 weeks, twice a day.
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.
Time frame: Change in respiratory function at 5 week
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
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
The exercise tolerance will be measure by 6 minute walk test 5 weeks apart.
Sponsors and collaborators
Lead sponsor
Federal University of Health Science of Porto Alegre
Other
Registry information
Official study title
Effects of a Program of Deep Inspiration Combined to Expiratory Positive Airway in Quality of Life and Heart Rate Variability
Important dates
- Study start
- 2011
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Jul 18, 2012
- Registry last updated
- Aug 11, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.