Chronic Obstructive Pulmonary DiseaseNCT02203058
Pursed-lips Breathing and Dynamic Hyperinflation
A study testing Pursed-lips breathing and No pursed-lips breathing in people with Chronic Obstructive Pulmonary Disease, run by University of the State of Santa Catarina at 1 site in Brazil.
Trial summary
Background: Dynamic hyperinflation (DH) is an important factor leading to dyspnea and consequent limitations in functional capacity of chronic obstructive pulmonary disease (COPD) patients. 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 No pursed-lips breathing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Jul 2013
- 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 GOLD stages 2, 3, and 4 of severity of airflow limitation
- history of smoking ≥ 20 pack-years
- clinical stability in the four weeks prior to the study protocol
Who cannot join
- long-term oxygen therapy
- current smoking
- any pulmonary disease other than COPD
- comorbidities that would compromise their ability to perform any of the evaluations in the study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Núcleo de Aisstência, Ensino e Pesquisa em Reabilitação Pulmonar
Florianópolis, Santa Catarina, 88080-350
About this study
Official title: Pursed-lips Breathing Reduces Reduces Dynamic Hyperinflation Induced by Activities of Daily Living Test in Patients With COPD
Background: Dynamic hyperinflation (DH) is an important factor leading to dyspnea and consequent limitations in functional capacity of chronic obstructive pulmonary disease (COPD) patients. It has not been completely elucidated whether pursed-lips breathing (PLB) is able to minimize DH and its effects on exercise tolerance in these patients. The aim of this study was to evaluate the acute effect of PLB on DH and functional capacity in patients with COPD.
Design: Randomized cross-over study. Setting: The study will be conducted in an outpatient pulmonary rehabilitation program in Florianópolis, Brazil.
Read more
Subjects: Twenty-five patients with COPD (16 men, mean age 64 (7) years, FEV1=41.7 (14.7)% predicted, BMI=27.6 (5.13)kg/m2).
Interventions: Patients will randomly perform two six-minute walk tests with and without PLB (6MWTPLB and 6MWTNon-PLB) and two Glittre-ADL tests with and without PLB (TGlittrePLB and TGlittreNon-PLB).
Main measures: At baseline and immediately after the tests, the inspiratory capacity (IC) will be assessed by the slow vital capacity (SVC) maneuver.
Read the detailed description
Pulmonary function testing Lung function will be tested using an Easy One spirometer (NDD Medical Technologies Inc., Zurich, Switzerland), and calibration checked before each evaluation. Spirometry will be performed in accordance with ATS/ERS standards (Miller et al, 2005). The predicted values will be calculated from the equations proposed by Pereira et al. (2007).
Inspiratory capacity (IC) measurement IC will be measured with the patient in the sitting position, using an Easy One portable spirometer (NDD Medical Technologies Inc., Zurich, Switzerland), before and immediately after the tests, by the slow vital capacity maneuver starting from a stable end-expiratory volume, in accordance with ATS/ERS standards (Miller et al,2005). A minimum of three maneuvers (maximum of eight) will be performed and, in order to be considered reproducible, two curves could not vary by more than 5% or 150mL. The higher value of two reproducible curves will be used for analysis. DH is considered when the IC decreased 10% and/or 150mL or more compared to the basal value (O'Donnell et al, 2001).
Six-minute walk test The 6MWT will be performed according to the guidelines of the American Thoracic Society (2002). Pulse oxygen saturation (SpO2; Oxi-Go, Oximeter Plus, Roslyn Heights, New York, USA) and dyspnea (Borg CR10 scale) will be measured at the beginning and at the end of the test. Predicted values for walking distance will be calculated according to Iwama et al. (2009).
Glittre-ADL test The TGlittre consists of completing a circuit as follows: from a sitting position, the subject stands up and walks along a flat 10-m long course, in the middle of which there is a two-step ladder (each step 17 cm high x 27 cm deep) to be climbed; after completing the 10 m, the subject faces a shelf containing three 1-kg objects positioned on the top shelf (shoulder height) and moves them one by one to the bottom shelf (waist height) and then to the floor; the objects are then returned to the bottom shelf and finally to the top shelf again; the subject walks back, climbing up and down the steps, until reaching the starting point (chair), sits down and immediately begins the next lap. The subjects carry a weighted backpack (2.5 kg for women, 5.0 kg for men) and are instructed to complete five laps on this circuit as quickly as possible. SpO2 and dyspnea index (Borg CR10 scale) will be measured at the beginning of the test, at the end of each lap, and at the end of the test (Skumlien et al, 2006).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pursed-lips breathing, No pursed-lips breathing
- Keywords
- Inspiratory capacity, Positive-pressure respiration, Exercise, Activities of daily living, COPD.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pursed-lips breathingOther
Expiration with pursed-lips during functional capacity tests.
No pursed-lips breathingOther
To avoid pursed-lips breathing, subjects use a a mouthpiece (2cm diameter X 2cm length) such as the one used in pulmonary functional tests.
| Study group | Role | What they receive |
|---|---|---|
| Pursed-lips breathing | Experimental | All patients performed both tests (six-minute walk test and Glittre ADL test) with pursed-lips breathing. Receives: Other: Pursed-lips breathing |
| No pursed-lips breathing | Placebo comparator | All patients performed both tests (six-minute walk test and Glittre ADL test) without pursed-lips breathing. Receives: Other: No pursed-lips breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic hyperinflation
Effect of pursed-lips breathing on inspiratory capacity during the six-minute walk test and Glittre-ADL test.
Measured: At the beginning and immediately after de six-minute walk test and Glittre ADL test.
Secondary outcomes (2)
Six-minute walk test performance
Effect of pursed-lips breathing on the distance walked (meters) during the six-minute walk test.
Measured: Both tests (with and without pursed-lips breathing) will be held at least two days to one week apart.
Glittre-ADL test performance
Effect of pursed-lips breathing on the time spent (minutes) performing the Glittre-ADL tes.
Measured: Both tests (with and without pursed-lips breathing) will be held at least two days to one week apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the State of Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dra. Anamaria Fleig Mayer, University of the State of Santa Catarina
- Investigators
- Anamaria F Mayer, PhD, Study director, Universidade do Estado de Santa Catraina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203058
- Sponsor's protocol ID
- PLB2014
- Status last verified
- Jul 2014
- First submitted
- 23 Jul 2014
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882Pereira CA, Sato T, Rodrigues SC. New reference values for forced spirometry in white adults in Brazil. J Bras Pneumol. 2007 Jul-Aug;33(4):397-406. doi: 10.1590/s1806-37132007000400008. English, Portuguese.
PubMed 17982531O'Donnell DE, Revill SM, Webb KA. Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):770-7. doi: 10.1164/ajrccm.164.5.2012122.
PubMed 11549531Iwama AM, Andrade GN, Shima P, Tanni SE, Godoy I, Dourado VZ. The six-minute walk test and body weight-walk distance product in healthy Brazilian subjects. Braz J Med Biol Res. 2009 Nov;42(11):1080-5. doi: 10.1590/s0100-879x2009005000032. Epub 2009 Oct 2.
PubMed 19802464ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Skumlien S, Hagelund T, Bjortuft O, Ryg MS. A field test of functional status as performance of activities of daily living in COPD patients. Respir Med. 2006 Feb;100(2):316-23. doi: 10.1016/j.rmed.2005.04.022. Epub 2005 Jun 6.
PubMed 15941658
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pursed-lips Breathing Reduces Reduces Dynamic Hyperinflation Induced by Activities of Daily Living Test in Patients With COPD
- ClinicalTrials.gov ID
- NCT02203058
- Acronym / sponsor ID
- PLB2014
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Inspiratory capacity, Positive-pressure respiration, Exercise, Activities of daily living, COPD.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of the State of Santa CatarinaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 29 Jul 2014 (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.
Background: Dynamic hyperinflation (DH) is an important factor leading to dyspnea and consequent limitations in functional capacity of chronic obstructive pulmonary disease (COPD) patients. It has not been completely elucidated whether pursed-lips breathing (PLB) is able to minimize DH and its effects on exercise tolerance in these patients. The aim of this study was to evaluate the acute effect of PLB on DH and functional capacity in patients with COPD.
Design: Randomized cross-over study. Setting: The study will be conducted in an outpatient pulmonary rehabilitation program in Florianópolis, Brazil.
Subjects: Twenty-five patients with COPD (16 men, mean age 64 (7) years, FEV1=41.7 (14.7)% predicted, BMI=27.6 (5.13)kg/m2).
Interventions: Patients will randomly perform two six-minute walk tests with and without PLB (6MWTPLB and 6MWTNon-PLB) and two Glittre-ADL tests with and without PLB (TGlittrePLB and TGlittreNon-PLB).
Main measures: At baseline and immediately after the tests, the inspiratory capacity (IC) will be assessed by the slow vital capacity (SVC) maneuver.
Detailed description
Pulmonary function testing Lung function will be tested using an Easy One spirometer (NDD Medical Technologies Inc., Zurich, Switzerland), and calibration checked before each evaluation. Spirometry will be performed in accordance with ATS/ERS standards (Miller et al, 2005). The predicted values will be calculated from the equations proposed by Pereira et al. (2007).
Inspiratory capacity (IC) measurement IC will be measured with the patient in the sitting position, using an Easy One portable spirometer (NDD Medical Technologies Inc., Zurich, Switzerland), before and immediately after the tests, by the slow vital capacity maneuver starting from a stable end-expiratory volume, in accordance with ATS/ERS standards (Miller et al,2005). A minimum of three maneuvers (maximum of eight) will be performed and, in order to be considered reproducible, two curves could not vary by more than 5% or 150mL. The higher value of two reproducible curves will be used for analysis. DH is considered when the IC decreased 10% and/or 150mL or more compared to the basal value (O'Donnell et al, 2001).
Six-minute walk test The 6MWT will be performed according to the guidelines of the American Thoracic Society (2002). Pulse oxygen saturation (SpO2; Oxi-Go, Oximeter Plus, Roslyn Heights, New York, USA) and dyspnea (Borg CR10 scale) will be measured at the beginning and at the end of the test. Predicted values for walking distance will be calculated according to Iwama et al. (2009).
Glittre-ADL test The TGlittre consists of completing a circuit as follows: from a sitting position, the subject stands up and walks along a flat 10-m long course, in the middle of which there is a two-step ladder (each step 17 cm high x 27 cm deep) to be climbed; after completing the 10 m, the subject faces a shelf containing three 1-kg objects positioned on the top shelf (shoulder height) and moves them one by one to the bottom shelf (waist height) and then to the floor; the objects are then returned to the bottom shelf and finally to the top shelf again; the subject walks back, climbing up and down the steps, until reaching the starting point (chair), sits down and immediately begins the next lap. The subjects carry a weighted backpack (2.5 kg for women, 5.0 kg for men) and are instructed to complete five laps on this circuit as quickly as possible. SpO2 and dyspnea index (Borg CR10 scale) will be measured at the beginning of the test, at the end of each lap, and at the end of the test (Skumlien et al, 2006).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pursed-lips breathing | Experimental | Other: Pursed-lips breathingAll patients performed both tests (six-minute walk test and Glittre ADL test) with pursed-lips breathing. |
| No pursed-lips breathing | Placebo comparator | Other: No pursed-lips breathingAll patients performed both tests (six-minute walk test and Glittre ADL test) without pursed-lips breathing. |
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 GOLD stages 2, 3, and 4 of severity of airflow limitation
- history of smoking ≥ 20 pack-years
- clinical stability in the four weeks prior to the study protocol
Key exclusion criteria (4 listed)
- long-term oxygen therapy
- current smoking
- any pulmonary disease other than COPD
- comorbidities that would compromise their ability to perform any of the evaluations in the study
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 breathingExpiration with pursed-lips during functional capacity tests. | Other | Pursed-lips breathing |
| No pursed-lips breathingTo avoid pursed-lips breathing, subjects use a a mouthpiece (2cm diameter X 2cm length) such as the one used in pulmonary functional tests. | Other | No pursed-lips breathing |
Primary outcome
Dynamic hyperinflation
Time frame: At the beginning and immediately after de six-minute walk test and Glittre ADL test.
Effect of pursed-lips breathing on inspiratory capacity during the six-minute walk test and Glittre-ADL test.
2 secondary outcomes
Six-minute walk test performance
Time frame: Both tests (with and without pursed-lips breathing) will be held at least two days to one week apart.
Glittre-ADL test performance
Time frame: Both tests (with and without pursed-lips breathing) will be held at least two days to one week apart.
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 29 Jul 2014.
- Background: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Background: PubMed 17982531Pereira CA, Sato T, Rodrigues SC. New reference values for forced spirometry in white adults in Brazil. J Bras Pneumol. 2007 Jul-Aug;33(4):397-406. doi: 10.1590/s1806-37132007000400008. English, Portuguese.
- Background: PubMed 11549531O'Donnell DE, Revill SM, Webb KA. Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):770-7. doi: 10.1164/ajrccm.164.5.2012122.
- Background: PubMed 19802464Iwama AM, Andrade GN, Shima P, Tanni SE, Godoy I, Dourado VZ. The six-minute walk test and body weight-walk distance product in healthy Brazilian subjects. Braz J Med Biol Res. 2009 Nov;42(11):1080-5. doi: 10.1590/s0100-879x2009005000032. Epub 2009 Oct 2.
- Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Background: PubMed 15941658Skumlien S, Hagelund T, Bjortuft O, Ryg MS. A field test of functional status as performance of activities of daily living in COPD patients. Respir Med. 2006 Feb;100(2):316-23. doi: 10.1016/j.rmed.2005.04.022. Epub 2005 Jun 6.
Related trials for Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
RecruitingPhase 2
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
Chronic Obstructive Pulmonary Disease (COPD)
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.
Anamaria F Mayer, PhD study director
Universidade do Estado de Santa Catraina
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 No pursed-lips breathing in people with Chronic Obstructive Pulmonary Disease, run by University of the State of Santa Catarina 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 29 Jul 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. Some participants in this study may receive a placebo. 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?
Dynamic hyperinflation (time frame: At the beginning and immediately after de six-minute walk test and Glittre ADL test.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02203058, which also lists 6 linked publications.
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 29 Jul 2014.