Chronic Obstructive Pulmonary DiseaseNCT02424331
Effect of Pursed Lips Breathing on Chest Wall, Mobility Diaphragmatic and Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease
A study testing Pursed Lips Breathing and Quiet Breathing in people with Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
This study aimed to evaluate the acute effect of PLB technique on diaphragmatic mobility, the kinematics of the thoracoabdominal complex analysis of lung volumes and exercise tolerance in patients with Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pursed Lips Breathing and Quiet Breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Mar 2015
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosis with stage II-IV (GOLD),
- Stable clinical condition (no exacerbation or hospital admission in the last four weeks preceding the study)
- Absence of other disease that may potentially contribute to dyspnea (heart disease, congestive heart failure, neuromuscular diseases, severe postural changes)
Who cannot join
- BMI> 30 kg / m2
- Musculoskeletal limitations
- Use of oxygen therapy
- Extreme discomfort during the procedure application
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate the acute effect of PLB technique on diaphragmatic mobility, the kinematics of the thoracoabdominal complex analysis of lung volumes and exercise tolerance in patients with Chronic Obstructive Pulmonary Disease (COPD). This is a study randomized cross-over clinical trial and blind, in subjects with Chronic Obstructive Pulmonary Disease (COPD) according to criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) (FEV1 / FVC <0.7 and FEV1 <80% predicted) selected at the Clinical Hospital of the Federal University of Pernambuco (UFPE) and Otavio de Freitas General Hospital (HGOF). The investigators recruited 13 patients COPD (according to previous sample calculation) aged between 40 and 80 years, of both sexes. The first day was held evaluation of lung function, respiratory muscle strength, body composition, dyspnea index and functional capacity. On the second day was held evaluation of thoracoabdominal complex kinematics by plethysmography Optoelectronics (OEP) with Quiet Breathing (QB) or pursed-lips breathing (PLB). Lung volumes with 2 minutes with QB and 6 minutes PLB or only 6 minutes by QB as randomization were observed. Before and after performing the requested breathing pattern diaphragmatic mobility was observed by Ultrasonography (US) and requested the patient an Inspiratory Capacity maneuver (IC). The evaluator who performed the ultrasound was blinded as to the beginning of the breathing pattern of order performed by the patient.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pursed Lips Breathing, Quiet Breathing
- Keywords
- Chronic Obstructive Pulmonary Disease, Respiratory mechanics, Plethysmography, Diaphragm, Respiratory muscles, Breathing exercises
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pursed Lips BreathingOther
Pursed Lips Breathing for six minutes.
Quiet BreathingOther
| Study group | Role | What they receive |
|---|---|---|
| Quiet Breathing or Pursed Lips Breathing | Experimental | Free or natural breathing for six minutes. Receives: Other: Pursed Lips Breathing; Other: Quiet Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest wall (Analysis of lung volumes)
(L) by plethysmography optoelectronics.
Measured: One day during eight minutes
Mobility diaphragmatic (mobility diaphragmatic (mm) by Ultrassonography)
Analysis of mobility diaphragmatic (mm) by Ultrassonography.
Measured: One day, before and after eight minutes of pursed lips breathing
Exercise tolerance (Glittre AVD-Test)
Analysis by Glittre AVD-Test (capacity functional test) observing the test execution time (s).
Measured: One day, for six minutes approximately. The test will be repeated after 20 minutes of rest.
Secondary outcomes (1)
Dyspnea (Borg and MRC Scale)
Assessed by Borg and MRC Scale (Medical Research Council).
Measured: One day, before and after implementation of Glittre-ADL Test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startMar 2014
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcely Kellyane Florenço Barros, Universidade Federal de Pernambuco
- Investigators
- Armele D Andrade, Dra, Study director, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424331
- Sponsor's protocol ID
- 19309213.3.0000.5208
- Status last verified
- Apr 2015
- First submitted
- 5 Mar 2015
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pursed Lips Breathing on Chest Wall, Mobility Diaphragmatic and Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02424331
- Acronym / sponsor ID
- 19309213.3.0000.5208
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Respiratory mechanics, Plethysmography, Diaphragm, Respiratory muscles, Breathing exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Apr 2015 (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.
This study aimed to evaluate the acute effect of PLB technique on diaphragmatic mobility, the kinematics of the thoracoabdominal complex analysis of lung volumes and exercise tolerance in patients with Chronic Obstructive Pulmonary Disease (COPD). This is a study randomized cross-over clinical trial and blind, in subjects with Chronic Obstructive Pulmonary Disease (COPD) according to criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) (FEV1 / FVC <0.7 and FEV1 <80% predicted) selected at the Clinical Hospital of the Federal University of Pernambuco (UFPE) and Otavio de Freitas General Hospital (HGOF). The investigators recruited 13 patients COPD (according to previous sample calculation) aged between 40 and 80 years, of both sexes. The first day was held evaluation of lung function, respiratory muscle strength, body composition, dyspnea index and functional capacity. On the second day was held evaluation of thoracoabdominal complex kinematics by plethysmography Optoelectronics (OEP) with Quiet Breathing (QB) or pursed-lips breathing (PLB). Lung volumes with 2 minutes with QB and 6 minutes PLB or only 6 minutes by QB as randomization were observed. Before and after performing the requested breathing pattern diaphragmatic mobility was observed by Ultrasonography (US) and requested the patient an Inspiratory Capacity maneuver (IC). The evaluator who performed the ultrasound was blinded as to the beginning of the breathing pattern of order performed by the patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quiet Breathing or Pursed Lips Breathing | Experimental | Other: Pursed Lips Breathing, Other: Quiet BreathingFree or natural breathing for six minutes. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD diagnosis with stage II-IV (GOLD),
- Stable clinical condition (no exacerbation or hospital admission in the last four weeks preceding the study)
- Absence of other disease that may potentially contribute to dyspnea (heart disease, congestive heart failure, neuromuscular diseases, severe postural changes)
Key exclusion criteria (4 listed)
- BMI> 30 kg / m2
- Musculoskeletal limitations
- Use of oxygen therapy
- Extreme discomfort during the procedure application
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 |
|---|---|---|
| Pursed Lips BreathingPursed Lips Breathing for six minutes. | Other | Quiet Breathing or Pursed Lips Breathing |
| Quiet Breathing | Other | Quiet Breathing or Pursed Lips Breathing |
Primary outcome
Chest wall (Analysis of lung volumes)
Time frame: One day during eight minutes
(L) by plethysmography optoelectronics.
Mobility diaphragmatic (mobility diaphragmatic (mm) by Ultrassonography)
Time frame: One day, before and after eight minutes of pursed lips breathing
Analysis of mobility diaphragmatic (mm) by Ultrassonography.
Exercise tolerance (Glittre AVD-Test)
Time frame: One day, for six minutes approximately. The test will be repeated after 20 minutes of rest.
Analysis by Glittre AVD-Test (capacity functional test) observing the test execution time (s).
1 secondary outcome
Dyspnea (Borg and MRC Scale)
Time frame: One day, before and after implementation of Glittre-ADL Test
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 23 Apr 2015.
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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.
Armele D Andrade, Dra study director
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pursed Lips Breathing and Quiet Breathing in people with Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Pernambuco 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 3 inclusion and 4 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 23 Apr 2015. 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?
Chest wall (Analysis of lung volumes) (time frame: One day during eight minutes). The study lists 3 primary outcomes in all. 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 23 Apr 2015.