Chronic Obstructive Pulmonary DiseaseNCT01173328
Effects of Pursed-lip Breathing on Exercise Tolerance and Dynamic Hyperinflation in COPD
A study testing Pursed-lip breathing and Normal Breathing in people with Chronic Obstructive Pulmonary Disease, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
Pursed-lip breathing (PLB) has been advocated to reduce respiratory rate and improve oxygen saturation in patients with chronic obstructive pulmonary disease (COPD) at rest. Although PLB is a strategy that potentially reduces expiratory flow limitation, there are only few studies addressing its effects on exercise. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pursed-lip breathing and Normal Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2007to Oct 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic obstructive pulmonary disease (COPD)
- Regular treatment at Clementino Fraga Filho University Hospital (UFRJ)
Who cannot join
- Exacerbation in the preceding 4 weeks
- SpO2<85% at peak exercise
- Other diseases that may contribute to dyspnea and exercise intolerance
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clementino Fraga Filho University Hospital
Rio de Janeiro, Rio de Janeiro
About this study
Official title: Effects of Pursed-lip Breathing on Exercise Tolerance and Dynamic Hyperinflation in Chronic Obstructive Pulmonary Disease
Pursed-lip breathing (PLB) has been advocated to reduce respiratory rate and improve oxygen saturation in patients with chronic obstructive pulmonary disease (COPD) at rest. Although PLB is a strategy that potentially reduces expiratory flow limitation, there are only few studies addressing its effects on exercise.
This study aimed to assess the ability of PLB to change the breathing pattern, degree of dynamic hyperinflation (DH) and arterial oxygenation in COPD patients during exercise. Exercise tolerance was evaluated by endurance time and respiratory mechanics was evaluated by forced oscillation technique.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pursed-lip breathing, Normal Breathing
- Keywords
- exercise tolerance, dynamic hyperinflation, respiratory mechanics
- 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-lip breathingBehavioural
Pursed-lip breathing involves a nasal inspiration followed by expiratory blowing against partially closed lips, avoiding forceful exhalation.
Normal BreathingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Pursed-lip Breathing | Experimental | Not described Receives: Behavioral: Pursed-lip breathing; Behavioral: Normal Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance time
Measured: within the first 01 hour
Secondary outcomes (4)
inspiratory capacity
Measured: within the first 01 hour
oxygen saturation
Measured: within the first 01 hour
dyspnea
Measured: within the first 01 hour
forced oscillation variables
Measured: within the first 01 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startMar 2007
- Primary completionOct 2009
- Study completionOct 2009
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Investigators
- Fernando S Guimarães, PhD, Study director, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173328
- Sponsor's protocol ID
- CEP/HUCFF/UFRJ 187/07
- Status last verified
- Aug 2008
- First submitted
- 19 Jul 2010
- Last updated
- 2 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pursed-lip Breathing on Exercise Tolerance and Dynamic Hyperinflation in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01173328
- Acronym / sponsor ID
- CEP/HUCFF/UFRJ 187/07
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- exercise tolerance, dynamic hyperinflation, respiratory mechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 2 Aug 2010 (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.
Pursed-lip breathing (PLB) has been advocated to reduce respiratory rate and improve oxygen saturation in patients with chronic obstructive pulmonary disease (COPD) at rest. Although PLB is a strategy that potentially reduces expiratory flow limitation, there are only few studies addressing its effects on exercise.
This study aimed to assess the ability of PLB to change the breathing pattern, degree of dynamic hyperinflation (DH) and arterial oxygenation in COPD patients during exercise. Exercise tolerance was evaluated by endurance time and respiratory mechanics was evaluated by forced oscillation technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pursed-lip Breathing | Experimental | Behavioral: Pursed-lip breathing, Behavioral: Normal Breathing |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of chronic obstructive pulmonary disease (COPD)
- Regular treatment at Clementino Fraga Filho University Hospital (UFRJ)
Key exclusion criteria (3 listed)
- Exacerbation in the preceding 4 weeks
- SpO2<85% at peak exercise
- Other diseases that may contribute to dyspnea and exercise intolerance
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-lip breathingPursed-lip breathing involves a nasal inspiration followed by expiratory blowing against partially closed lips, avoiding forceful exhalation. | Behavioural | Pursed-lip Breathing |
| Normal Breathing | Behavioural | Pursed-lip Breathing |
Primary outcome
Endurance time
Time frame: within the first 01 hour
4 secondary outcomes
inspiratory capacity
Time frame: within the first 01 hour
oxygen saturation
Time frame: within the first 01 hour
dyspnea
Time frame: within the first 01 hour
forced oscillation variables
Time frame: within the first 01 hour
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 2 Aug 2010.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host 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.
Fernando S Guimarães, PhD study director
Universidade Federal do Rio de Janeiro
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-lip breathing and Normal Breathing in people with Chronic Obstructive Pulmonary Disease, run by Universidade Federal do Rio de Janeiro 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 3 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 2 Aug 2010. 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?
Endurance time (time frame: within the first 01 hour). 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 2 Aug 2010.