Pursed-lips Breathing and Dynamic Hyperinflation

July 25, 2014 updated by: Prof. Dra. Anamaria Fleig Mayer, University of the State of Santa Catarina

Pursed-lips Breathing Reduces Reduces Dynamic Hyperinflation Induced by Activities of Daily Living Test in Patients With COPD

Background: Dynamic hyperinflation (DH) is an important factor leading to dyspnea and consequent limitations in functional capacity of chronic obstructive pulmonary disease (COPD) patients. It has not been completely elucidated whether pursed-lips breathing (PLB) is able to minimize DH and its effects on exercise tolerance in these patients. The aim of this study was to evaluate the acute effect of PLB on DH and functional capacity in patients with COPD.

Design: Randomized cross-over study. Setting: The study will be conducted in an outpatient pulmonary rehabilitation program in Florianópolis, Brazil.

Subjects: Twenty-five patients with COPD (16 men, mean age 64 (7) years, FEV1=41.7 (14.7)% predicted, BMI=27.6 (5.13)kg/m2).

Interventions: Patients will randomly perform two six-minute walk tests with and without PLB (6MWTPLB and 6MWTNon-PLB) and two Glittre-ADL tests with and without PLB (TGlittrePLB and TGlittreNon-PLB).

Main measures: At baseline and immediately after the tests, the inspiratory capacity (IC) will be assessed by the slow vital capacity (SVC) maneuver.

Study Overview

Detailed Description

Pulmonary function testing Lung function will be tested using an Easy One spirometer (NDD Medical Technologies Inc., Zurich, Switzerland), and calibration checked before each evaluation. Spirometry will be performed in accordance with ATS/ERS standards (Miller et al, 2005). The predicted values will be calculated from the equations proposed by Pereira et al. (2007).

Inspiratory capacity (IC) measurement IC will be measured with the patient in the sitting position, using an Easy One portable spirometer (NDD Medical Technologies Inc., Zurich, Switzerland), before and immediately after the tests, by the slow vital capacity maneuver starting from a stable end-expiratory volume, in accordance with ATS/ERS standards (Miller et al,2005). A minimum of three maneuvers (maximum of eight) will be performed and, in order to be considered reproducible, two curves could not vary by more than 5% or 150mL. The higher value of two reproducible curves will be used for analysis. DH is considered when the IC decreased 10% and/or 150mL or more compared to the basal value (O'Donnell et al, 2001).

Six-minute walk test The 6MWT will be performed according to the guidelines of the American Thoracic Society (2002). Pulse oxygen saturation (SpO2; Oxi-Go, Oximeter Plus, Roslyn Heights, New York, USA) and dyspnea (Borg CR10 scale) will be measured at the beginning and at the end of the test. Predicted values for walking distance will be calculated according to Iwama et al. (2009).

Glittre-ADL test The TGlittre consists of completing a circuit as follows: from a sitting position, the subject stands up and walks along a flat 10-m long course, in the middle of which there is a two-step ladder (each step 17 cm high x 27 cm deep) to be climbed; after completing the 10 m, the subject faces a shelf containing three 1-kg objects positioned on the top shelf (shoulder height) and moves them one by one to the bottom shelf (waist height) and then to the floor; the objects are then returned to the bottom shelf and finally to the top shelf again; the subject walks back, climbing up and down the steps, until reaching the starting point (chair), sits down and immediately begins the next lap. The subjects carry a weighted backpack (2.5 kg for women, 5.0 kg for men) and are instructed to complete five laps on this circuit as quickly as possible. SpO2 and dyspnea index (Borg CR10 scale) will be measured at the beginning of the test, at the end of each lap, and at the end of the test (Skumlien et al, 2006).

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88080-350
        • Núcleo de Aisstência, Ensino e Pesquisa em Reabilitação Pulmonar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • COPD GOLD stages 2, 3, and 4 of severity of airflow limitation
  • history of smoking ≥ 20 pack-years
  • clinical stability in the four weeks prior to the study protocol

Exclusion Criteria:

  • long-term oxygen therapy
  • current smoking
  • any pulmonary disease other than COPD
  • comorbidities that would compromise their ability to perform any of the evaluations in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pursed-lips breathing
All patients performed both tests (six-minute walk test and Glittre ADL test) with pursed-lips breathing.
Expiration with pursed-lips during functional capacity tests.
Placebo Comparator: No pursed-lips breathing
All patients performed both tests (six-minute walk test and Glittre ADL test) without pursed-lips breathing.
To avoid pursed-lips breathing, subjects use a a mouthpiece (2cm diameter X 2cm length) such as the one used in pulmonary functional tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic hyperinflation
Time Frame: At the beginning and immediately after de six-minute walk test and Glittre ADL test.
Effect of pursed-lips breathing on inspiratory capacity during the six-minute walk test and Glittre-ADL test.
At the beginning and immediately after de six-minute walk test and Glittre ADL test.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six-minute walk test performance
Time Frame: Both tests (with and without pursed-lips breathing) will be held at least two days to one week apart.
Effect of pursed-lips breathing on the distance walked (meters) during the six-minute walk test.
Both tests (with and without pursed-lips breathing) will be held at least two days to one week apart.
Glittre-ADL test performance
Time Frame: Both tests (with and without pursed-lips breathing) will be held at least two days to one week apart.
Effect of pursed-lips breathing on the time spent (minutes) performing the Glittre-ADL tes.
Both tests (with and without pursed-lips breathing) will be held at least two days to one week apart.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Anamaria F Mayer, PhD, Universidade do Estado de Santa Catraina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 25, 2014

First Posted (Estimate)

July 29, 2014

Study Record Updates

Last Update Posted (Estimate)

July 29, 2014

Last Update Submitted That Met QC Criteria

July 25, 2014

Last Verified

July 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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