NCT02934750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2017

Completed
Last Updated

February 1, 2017

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

October 12, 2016

Last Update Submit

January 31, 2017

Conditions

Interstitial Lung Disease

Keywords

pursed lip breathinginterstitial lund diseaseexercise physiology

Outcome Measures

Primary Outcomes (1)

  • Exertional dyspnea

    Patient-reported dyspnea will be measured using the Borg scale

    On the day of randomization

Secondary Outcomes (7)

  • Six-minute walking distance

    On the day of randomization

  • Oxygen uptake (ml/min)

    On the day of randomization, at each minute of the 6-minute walking test

  • Carbon dioxide output (ml/min)

    On the day of randomization, at each minute of the 6-minute walking test

  • Respiratory rate (br/min)

    On the day of randomization, at each minute of the 6-minute walking test

  • Tidal volume (ml)

    On the day of randomization, at each minute of the 6-minute walking test

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

Pursed lip breathingBEHAVIORAL

Pursed 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.

Pursed lip breathing

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUM (Notre-Dame Hospital)

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (1)

  • 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.

    PMID: 30624373DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Bruno-Pierre Dubé, MD

    Centre Hospitalier de l'Universite de Montreal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 17, 2016

Study Start

October 1, 2016

Primary Completion

January 30, 2017

Study Completion

January 30, 2017

Last Updated

February 1, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)