Pursed-lips Breathing and Dynamic Hyperinflation

NCT02203058 | Completed

• 1 other identifier: PLB2014
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Inspiratory capacity; Positive-pressure respiration; Exercise; Activities of daily living; COPD.

Outcome Measures

Primary Outcomes (1)

• Dynamic hyperinflation

  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 Outcomes (2)

• Six-minute walk test performance

  Both tests (with and without pursed-lips breathing) will be held at least two days to one week apart.

• Glittre-ADL test performance

  Both tests (with and without pursed-lips breathing) will be held at least two days to one week apart.

Study Arms (2)

Pursed-lips breathing

EXPERIMENTAL

All patients performed both tests (six-minute walk test and Glittre ADL test) with pursed-lips breathing.

Other: Pursed-lips breathing

No pursed-lips breathing

PLACEBO COMPARATOR

All patients performed both tests (six-minute walk test and Glittre ADL test) without pursed-lips breathing.

Other: No pursed-lips breathing

Interventions

Pursed-lips breathing OTHER

Expiration with pursed-lips during functional capacity tests.

Pursed-lips breathing

No pursed-lips breathing OTHER

To avoid pursed-lips breathing, subjects use a a mouthpiece (2cm diameter X 2cm length) such as the one used in pulmonary functional tests.

No pursed-lips breathing

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the State of Santa Catarina: lead

Study Sites (1)

Núcleo de Aisstência, Ensino e Pesquisa em Reabilitação Pulmonar

Florianópolis, Santa Catarina, 88080-350, Brazil

Location

Related Publications (6)

• Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

  PMID: 16055882 BACKGROUND

• Pereira CA, Sato T, Rodrigues SC. New reference values for forced spirometry in white adults in Brazil. J Bras Pneumol. 2007 Jul-Aug;33(4):397-406. doi: 10.1590/s1806-37132007000400008. English, Portuguese.

  PMID: 17982531 BACKGROUND

• O'Donnell DE, Revill SM, Webb KA. Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):770-7. doi: 10.1164/ajrccm.164.5.2012122.

  PMID: 11549531 BACKGROUND

• Iwama AM, Andrade GN, Shima P, Tanni SE, Godoy I, Dourado VZ. The six-minute walk test and body weight-walk distance product in healthy Brazilian subjects. Braz J Med Biol Res. 2009 Nov;42(11):1080-5. doi: 10.1590/s0100-879x2009005000032. Epub 2009 Oct 2.

  PMID: 19802464 BACKGROUND

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 BACKGROUND

• Skumlien S, Hagelund T, Bjortuft O, Ryg MS. A field test of functional status as performance of activities of daily living in COPD patients. Respir Med. 2006 Feb;100(2):316-23. doi: 10.1016/j.rmed.2005.04.022. Epub 2005 Jun 6.

  PMID: 15941658 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Anamaria F Mayer, PhD

  Universidade do Estado de Santa Catraina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 29, 2014
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 29, 2014

Record last verified: 2014-07

Locations

BR (1)