Improvement of Functional Capacity.NCT01643421
Effect of a Program of Deep Inspiration Combined to Expiratory Positive Airway Pressure in Asthmatic
A study testing Deep inspiration and positive expiratory airway pressure in people with Improvement of Functional Capacity. and Improvement of Quality of Life., run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Improvement of Functional Capacity., Improvement of Quality of Life., Improvement of Cardiovascular Autonomic Control.
- What is being tested?
- Deep inspiration and positive expiratory airway pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 80
- Severe asthma
Who cannot join
- Disagreement with consent form
- Other respiratory disease
- Acute severe asthma
- Pregnancy or breastfeeding
- Current smoking
- Lack of capable of conducting the study visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Improvement of Functional Capacity., Improvement of Quality of Life., Improvement of Cardiovascular Autonomic Control.
- Being tested
- Deep inspiration and positive expiratory airway pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep inspiration and positive expiratory airway pressureOther
It was used a device the combines deep inspiration and positive expiratory airway pressure in asthmatic subjects, for 5 weeks, twice a day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Deep inspiration and positive expiratory airway pressure |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The respiratory function will be measure by spirometry 5 weeks apart.
Measured: 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.
Measured: 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.
Measured: Change in exercise tolerance at 5 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improvement of Functional Capacity.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Dal Lago, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643421
- Sponsor's protocol ID
- II+EPAP
- Status last verified
- Aug 2014
- First submitted
- 10 Jul 2012
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Program of Deep Inspiration Combined to Expiratory Positive Airway in Quality of Life and Heart Rate Variability
- ClinicalTrials.gov ID
- NCT01643421
- Acronym / sponsor ID
- II+EPAP
- Conditions
- Improvement of Functional Capacity., Improvement of Quality of Life., Improvement of Cardiovascular Autonomic Control.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep inspiration and expiratory positive airway pressure | Experimental | Other: Deep inspiration and positive expiratory airway pressureThe protocol of deep inspiration combined to expiratory positive airway pressure will be applied in asthmatic subjects. |
| Control | No intervention | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 20 and 80
- Severe asthma
Key exclusion criteria (6 listed)
- Disagreement with consent form
- Other respiratory disease
- Acute severe asthma
- Pregnancy or breastfeeding
- Current smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep inspiration and positive expiratory airway pressureIt was used a device the combines deep inspiration and positive expiratory airway pressure in asthmatic subjects, for 5 weeks, twice a day. | Other | Deep inspiration and expiratory positive airway pressure |
Primary outcome
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.
3 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 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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
Related trials for Improvement of Functional Capacity.
Recruiting
Anderson-Fabry Disease Fitness Improvement Training
Fabry Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep inspiration and positive expiratory airway pressure in people with Improvement of Functional Capacity. and Improvement of Quality of Life., run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2014.