Pursed Lip Breathing in Interstitial Lung Disease
January 31, 2017 updated by: Centre hospitalier de l'Université de Montréal (CHUM)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H2L 4M1
- CHUM (Notre-Dame Hospital)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pursed lip breathing
In this arm, patients will be asked to perform a six-minute walking test while continuously using the pursed lip breathing technique.
|
Pursed lip breathing will be taught to the participants following the chronic obstructive pulmonary disease (COPD) Foundation recommendations:
|
|
No Intervention: Usual breathing
In this control arm, patients will be asked to perform a six-minute walking test while breathing normally.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exertional dyspnea
Time Frame: On the day of randomization
|
Patient-reported dyspnea will be measured using the Borg scale
|
On the day of randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Six-minute walking distance
Time Frame: On the day of randomization
|
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
|
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
|
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
|
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
|
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
|
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
|
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
|
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
|
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
|
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
|
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
|
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
|
On the day of randomization, at each minute of the 6-minute walking test
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Bruno-Pierre Dubé, MD, Centre hospitalier de l'Université de Montréal (CHUM)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Actual)
January 30, 2017
Study Completion (Actual)
January 30, 2017
Study Registration Dates
First Submitted
October 12, 2016
First Submitted That Met QC Criteria
October 14, 2016
First Posted (Estimate)
October 17, 2016
Study Record Updates
Last Update Posted (Estimate)
February 1, 2017
Last Update Submitted That Met QC Criteria
January 31, 2017
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE15.347
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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