Interstitial Lung DiseaseNCT02934750
Pursed Lip Breathing in Interstitial Lung Disease
A study testing Pursed lip breathing in people with Interstitial Lung Disease, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
This randomized, cross-over study aims at describing the effect of pursed lip breathing on exercise-induced dyspnea and exercise capacity in patients with interstitial lung disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Pursed lip breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to 30 Jan 2017
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of interstitial lung disease, based on the results of a multidisciplinary diagnosis discussion.
- Restrictive ventilatory defect (i.e. total lung capacity (TLC) < 80% of predicted value) on pulmonary function testing.
Who cannot join
- Active cancer
- History of severe heart disease
- Neurological or orthopaedic problem that could interfere with exercise performance
- Physiological mixed syndromes (i.e. concomitant restrictive and obstructive defects)
- Exacerbation of disease or hospitalisation in the last 4 weeks prior to enrollment
- Long-term oxygen therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pursed Lip Breathing on Exercise Capacity and Dyspnea in Patients With Interstitial Lung Disease: a Randomized Crossover Study
This randomized, cross-over study aims at describing the effect of pursed lip breathing on exercise-induced dyspnea and exercise capacity in patients with interstitial lung disease.
Read the detailed description
The use of pursed lip breathing (PLB) to improve exercise tolerance in COPD patients has been widely documented. However, its efficacy in patients with interstitial lung disease (ILD) has yet to be confirmed. This study aims to determine if PLB improves perceived exertion and exercise capacity during a six-minute walk test (6MWT) in patients with ILD. To achieve this, a prospective randomized crossover trial will be performed, in which patients with ILD and restrictive ventilatory defect will be recruited via the ILD clinic of Hôpital Notre-Dame. The study will be performed in a single visit, on the day where patients attend a routine physician-prescribed follow-up 6MWT. Patients will be asked to perform a total of two 6MWT. Patients will be randomized to perform the first test with or without using PLB, and the order will be reversed for the second test, with patients serving as their own control. During tests, ventilatory variables will be continuously measured using a portable metabolic cart. The observed parameters will be: perceived exertion using the Modified-Borg Scale, respiratory rate, minute-ventilation, heart rate, peripheral oxygen saturation, and 6-minute walk distance (6MWD). It is expected that the use of PLB will be associated with a decrease of at least one unit on the Modified Borg Scale, which would be clinically significant. Moreover, it is expected that the decrease in dyspnea with PLB will be related to a decrease in respiratory rate minute ventilation during 6MWT. The clinical impact of this study could be significant as therapies allowing the improvement of dyspnea in patients with ILD are scarce.
- Conditions
- Interstitial Lung Disease
- Being tested
- Pursed lip breathing
- Keywords
- pursed lip breathing, interstitial lund disease, exercise physiology
- Medical subject headings
- Lung Diseases, Interstitial
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 will be taught to the participants following the chronic obstructive pulmonary disease (COPD) Foundation recommendations:
- Breathe in through your nose (as if you are smelling something) for about 2 seconds.
- Pucker your lips like you're getting ready to blow out candles on a birthday cake.
- Breathe out very slowly through pursed-lips, two to three times as long as you breathed in.
- Repeat.
| Study group | Role | What they receive |
|---|---|---|
| Pursed lip breathing | Experimental | In this arm, patients will be asked to perform a six-minute walking test while continuously using the pursed lip breathing technique. Receives: Behavioral: Pursed lip breathing |
| Usual breathing | No intervention | In this control arm, patients will be asked to perform a six-minute walking test while breathing normally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exertional dyspnea
Patient-reported dyspnea will be measured using the Borg scale
Measured: On the day of randomization
Secondary outcomes (7)
Six-minute walking distance
Measured: On the day of randomization
Oxygen uptake (ml/min)
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Measured: On the day of randomization, at each minute of the 6-minute walking test
Carbon dioxide output (ml/min)
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Measured: On the day of randomization, at each minute of the 6-minute walking test
Respiratory rate (br/min)
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Measured: On the day of randomization, at each minute of the 6-minute walking test
Tidal volume (ml)
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Measured: On the day of randomization, at each minute of the 6-minute walking test
Minute-ventilation (l/min)
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Measured: On the day of randomization, at each minute of the 6-minute walking test
Peripheral oxygen saturation (%)
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Measured: On the day of randomization, at each minute of the 6-minute walking test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion30 Jan 2017
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Université du Québec a Montréal
- Responsible party
- Sponsor
- Investigators
- Bruno-Pierre Dubé, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934750
- Sponsor's protocol ID
- CE15.347
- Status last verified
- Oct 2016
- First submitted
- 12 Oct 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Parisien-La Salle S, Abel Rivest E, Boucher VG, Lalande-Gauthier M, Morisset J, Manganas H, Poirier C, Comtois AS, Dube BP. Effects of Pursed Lip Breathing on Exercise Capacity and Dyspnea in Patients With Interstitial Lung Disease: A RANDOMIZED, CROSSOVER STUDY. J Cardiopulm Rehabil Prev. 2019 Mar;39(2):112-117. doi: 10.1097/HCR.0000000000000387.
PubMed 30624373
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pursed Lip Breathing on Exercise Capacity and Dyspnea in Patients With Interstitial Lung Disease: a Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT02934750
- Acronym / sponsor ID
- CE15.347
- Conditions
- Interstitial Lung Disease
- Keywords
- pursed lip breathing, interstitial lund disease, exercise physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Université du Québec a Montréal
- Study start
- Oct 2016
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 17 Oct 2016 (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 randomized, cross-over study aims at describing the effect of pursed lip breathing on exercise-induced dyspnea and exercise capacity in patients with interstitial lung disease.
Detailed description
The use of pursed lip breathing (PLB) to improve exercise tolerance in COPD patients has been widely documented. However, its efficacy in patients with interstitial lung disease (ILD) has yet to be confirmed. This study aims to determine if PLB improves perceived exertion and exercise capacity during a six-minute walk test (6MWT) in patients with ILD. To achieve this, a prospective randomized crossover trial will be performed, in which patients with ILD and restrictive ventilatory defect will be recruited via the ILD clinic of Hôpital Notre-Dame. The study will be performed in a single visit, on the day where patients attend a routine physician-prescribed follow-up 6MWT. Patients will be asked to perform a total of two 6MWT. Patients will be randomized to perform the first test with or without using PLB, and the order will be reversed for the second test, with patients serving as their own control. During tests, ventilatory variables will be continuously measured using a portable metabolic cart. The observed parameters will be: perceived exertion using the Modified-Borg Scale, respiratory rate, minute-ventilation, heart rate, peripheral oxygen saturation, and 6-minute walk distance (6MWD). It is expected that the use of PLB will be associated with a decrease of at least one unit on the Modified Borg Scale, which would be clinically significant. Moreover, it is expected that the decrease in dyspnea with PLB will be related to a decrease in respiratory rate minute ventilation during 6MWT. The clinical impact of this study could be significant as therapies allowing the improvement of dyspnea in patients with ILD are scarce.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pursed lip breathing | Experimental | Behavioral: Pursed lip breathingIn this arm, patients will be asked to perform a six-minute walking test while continuously using the pursed lip breathing technique. |
| Usual breathing | No intervention | –In this control arm, patients will be asked to perform a six-minute walking test while breathing normally. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of interstitial lung disease, based on the results of a multidisciplinary diagnosis discussion.
- Restrictive ventilatory defect (i.e. total lung capacity (TLC) < 80% of predicted value) on pulmonary function testing.
Key exclusion criteria (6 listed)
- Active cancer
- History of severe heart disease
- Neurological or orthopaedic problem that could interfere with exercise performance
- Physiological mixed syndromes (i.e. concomitant restrictive and obstructive defects)
- Exacerbation of disease or hospitalisation in the last 4 weeks prior to enrollment
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 will be taught to the participants following the chronic obstructive pulmonary disease (COPD) Foundation recommendations: 1. Breathe in through your nose (as if you are smelling something) for about 2 seconds. 2. Pucker your lips like you're getting ready to blow out candles on a birthday cake. 3. Breathe out very slowly through pursed-lips, two to three times as long as you breathed in. 4. Repeat. | Behavioural | Pursed lip breathing |
Primary outcome
Exertional dyspnea
Time frame: On the day of randomization
Patient-reported dyspnea will be measured using the Borg scale
7 secondary outcomes
Six-minute walking distance
Time frame: On the day of randomization
Oxygen uptake (ml/min)
Time frame: On the day of randomization, at each minute of the 6-minute walking test
Carbon dioxide output (ml/min)
Time frame: On the day of randomization, at each minute of the 6-minute walking test
Respiratory rate (br/min)
Time frame: On the day of randomization, at each minute of the 6-minute walking test
Tidal volume (ml)
Time frame: On the day of randomization, at each minute of the 6-minute walking test
Minute-ventilation (l/min)
Time frame: On the day of randomization, at each minute of the 6-minute walking test
Peripheral oxygen saturation (%)
Time frame: On the day of randomization, at each minute of the 6-minute walking 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 1 Feb 2017.
- Derived from this study: PubMed 30624373Parisien-La Salle S, Abel Rivest E, Boucher VG, Lalande-Gauthier M, Morisset J, Manganas H, Poirier C, Comtois AS, Dube BP. Effects of Pursed Lip Breathing on Exercise Capacity and Dyspnea in Patients With Interstitial Lung Disease: A RANDOMIZED, CROSSOVER STUDY. J Cardiopulm Rehabil Prev. 2019 Mar;39(2):112-117. doi: 10.1097/HCR.0000000000000387.
- Individual participant dataSharing planned: No
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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.
Bruno-Pierre Dubé, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
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 in people with Interstitial Lung Disease, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 1 Feb 2017. 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 Canada. 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?
Exertional dyspnea (time frame: On the day of randomization). 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 NCT02934750, which also lists 1 linked publication.
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 1 Feb 2017.