Clinical trial NCT02934750: 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
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Lung Disease
Keywords: pursed lip breathing
interstitial lund disease
exercise physiology
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Université du Québec a Montréal
First posted: 2016-10-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Exertional dyspnea
timeFrame: On the day of randomization
Secondary outcomes:
measure: Six-minute walking distance
timeFrame: On the day of randomization
measure: Oxygen uptake (ml/min)
timeFrame: On the day of randomization, at each minute of the 6-minute walking test
measure: Carbon dioxide output (ml/min)
timeFrame: On the day of randomization, at each minute of the 6-minute walking test
measure: Respiratory rate (br/min)
timeFrame: On the day of randomization, at each minute of the 6-minute walking test
measure: Tidal volume (ml)
timeFrame: On the day of randomization, at each minute of the 6-minute walking test
measure: Minute-ventilation (l/min)
timeFrame: On the day of randomization, at each minute of the 6-minute walking test
measure: Peripheral oxygen saturation (%)
timeFrame: On the day of randomization, at each minute of the 6-minute walking test
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHUM (Notre-Dame Hospital)
state: Quebec
Study officials:
affiliation: Centre Hospitalier de l'Universite de Montreal (CHUM)
name: Bruno-Pierre Dubé, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.