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Completed

NCT Number: NCT02934750

Pursed Lip Breathing in Interstitial Lung Disease

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.

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Key information

Conditions

Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUM (Notre-Dame Hospital)

Montreal, Quebec, H2L 4M1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pursed lip breathing

Behavioral

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 outcomes

  1. Exertional dyspnea

    Time frame: On the day of randomization

    Patient-reported dyspnea will be measured using the Borg scale

Secondary outcomes

  1. Six-minute walking distance

    Time frame: On the day of randomization

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Université du Québec a Montréal

Registry information

Official study title

Effects of Pursed Lip Breathing on Exercise Capacity and Dyspnea in Patients With Interstitial Lung Disease: a Randomized Crossover Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2016
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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