Effects of Pursed-lip Breathing on Exercise Tolerance and... | NCT01173328

Studies
Effects of Pursed-lip Breathing on Exercise Tolerance and Dynamic Hyperinflation in COPD

NCT01173328

Sponsor

Universidade Federal do Rio de Janeiro

Status

Completed

Last Update Posted

Aug 2, 2010Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Pursed-lip breathing
Normal Breathing

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Jul 19, 2010

First Submission Date that Met QC Criteria

Jul 30, 2010

First Posted Date

Aug 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2010

Last Update Posted Date

Aug 2, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pursed-lip Breathing	Experimental		Behavioral: Pursed-lip breathing Behavioral: Normal Breathing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pursed-lip breathing	Behavioral	Pursed-lip breathing involves a nasal inspiration followed by expiratory blowing against partially closed lips, avoiding forceful exhalation.	Pursed-lip Breathing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Endurance time		within the first 01 hour

Secondary Outcomes

Measure	Description	Time Frame
inspiratory capacity		within the first 01 hour
oxygen saturation		within the first 01 hour
dyspnea

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fernando S Guimarães, PhD	Universidade Federal do Rio de Janeiro	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clementino Fraga Filho University Hospital		Rio de Janeiro	Rio de Janeiro		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided