Pursed Lip Breathing in Interstitial Lung Disease
Primary Purpose
Interstitial Lung Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pursed lip breathing
Sponsored by
About this trial
This is an interventional supportive care trial for Interstitial Lung Disease focused on measuring pursed lip breathing, interstitial lund disease, exercise physiology
Eligibility Criteria
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
Sites / Locations
- CHUM (Notre-Dame Hospital)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pursed lip breathing
Usual breathing
Arm Description
In this arm, patients will be asked to perform a six-minute walking test while continuously using the pursed lip breathing technique.
In this control arm, patients will be asked to perform a six-minute walking test while breathing normally.
Outcomes
Primary Outcome Measures
Exertional dyspnea
Patient-reported dyspnea will be measured using the Borg scale
Secondary Outcome Measures
Six-minute walking distance
Oxygen uptake (ml/min)
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Carbon dioxide output (ml/min)
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Respiratory rate (br/min)
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Tidal volume (ml)
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Minute-ventilation (l/min)
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Peripheral oxygen saturation (%)
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Full Information
NCT ID
NCT02934750
First Posted
October 12, 2016
Last Updated
January 31, 2017
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Université du Québec a Montréal
1. Study Identification
Unique Protocol Identification Number
NCT02934750
Brief Title
Pursed Lip Breathing in Interstitial Lung Disease
Official Title
Effects of Pursed Lip Breathing on Exercise Capacity and Dyspnea in Patients With Interstitial Lung Disease: a Randomized Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
January 30, 2017 (Actual)
Study Completion Date
January 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Université du Québec a Montréal
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
Keywords
pursed lip breathing, interstitial lund disease, exercise physiology
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pursed lip breathing
Arm Type
Experimental
Arm Description
In this arm, patients will be asked to perform a six-minute walking test while continuously using the pursed lip breathing technique.
Arm Title
Usual breathing
Arm Type
No Intervention
Arm Description
In this control arm, patients will be asked to perform a six-minute walking test while breathing normally.
Intervention Type
Behavioral
Intervention Name(s)
Pursed lip breathing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exertional dyspnea
Description
Patient-reported dyspnea will be measured using the Borg scale
Time Frame
On the day of randomization
Secondary Outcome Measure Information:
Title
Six-minute walking distance
Time Frame
On the day of randomization
Title
Oxygen uptake (ml/min)
Description
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Time Frame
On the day of randomization, at each minute of the 6-minute walking test
Title
Carbon dioxide output (ml/min)
Description
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Time Frame
On the day of randomization, at each minute of the 6-minute walking test
Title
Respiratory rate (br/min)
Description
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Time Frame
On the day of randomization, at each minute of the 6-minute walking test
Title
Tidal volume (ml)
Description
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Time Frame
On the day of randomization, at each minute of the 6-minute walking test
Title
Minute-ventilation (l/min)
Description
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Time Frame
On the day of randomization, at each minute of the 6-minute walking test
Title
Peripheral oxygen saturation (%)
Description
Non-invasive real-time measurements will be performed using a portable metabolic cart system.
Time Frame
On the day of randomization, at each minute of the 6-minute walking test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno-Pierre Dubé, MD
Organizational Affiliation
Centre Hospitalier de l'Universite de Montreal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUM (Notre-Dame Hospital)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30624373
Citation
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.
Results Reference
derived
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Pursed Lip Breathing in Interstitial Lung Disease
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