NCT01173328

Brief Summary

Pursed-lip breathing (PLB) has been advocated to reduce respiratory rate and improve oxygen saturation in patients with chronic obstructive pulmonary disease (COPD) at rest. Although PLB is a strategy that potentially reduces expiratory flow limitation, there are only few studies addressing its effects on exercise. This study aimed to assess the ability of PLB to change the breathing pattern, degree of dynamic hyperinflation (DH) and arterial oxygenation in COPD patients during exercise. Exercise tolerance was evaluated by endurance time and respiratory mechanics was evaluated by forced oscillation technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2007

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 2, 2010

Completed
Last Updated

August 2, 2010

Status Verified

August 1, 2008

Enrollment Period

2.6 years

First QC Date

July 19, 2010

Last Update Submit

July 30, 2010

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

exercise tolerancedynamic hyperinflationrespiratory mechanics

Outcome Measures

Primary Outcomes (1)

  • Endurance time

    within the first 01 hour

Secondary Outcomes (4)

  • inspiratory capacity

    within the first 01 hour

  • oxygen saturation

    within the first 01 hour

  • dyspnea

    within the first 01 hour

  • forced oscillation variables

    within the first 01 hour

Study Arms (1)

Pursed-lip Breathing

EXPERIMENTAL
Behavioral: Pursed-lip breathingBehavioral: Normal Breathing

Interventions

Pursed-lip breathingBEHAVIORAL

Pursed-lip breathing involves a nasal inspiration followed by expiratory blowing against partially closed lips, avoiding forceful exhalation.

Pursed-lip Breathing
Normal BreathingBEHAVIORAL
Pursed-lip Breathing

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of chronic obstructive pulmonary disease (COPD)
  • Regular treatment at Clementino Fraga Filho University Hospital (UFRJ)

You may not qualify if:

  • Exacerbation in the preceding 4 weeks
  • SpO2\<85% at peak exercise
  • Other diseases that may contribute to dyspnea and exercise intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clementino Fraga Filho University Hospital

Rio de Janeiro, Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fernando S Guimarães, PhD

    Universidade Federal do Rio de Janeiro

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2010

First Posted

August 2, 2010

Study Start

March 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

August 2, 2010

Record last verified: 2008-08

Locations

BR(1)