NCT02424331

Brief Summary

This study aimed to evaluate the acute effect of PLB technique on diaphragmatic mobility, the kinematics of the thoracoabdominal complex analysis of lung volumes and exercise tolerance in patients with Chronic Obstructive Pulmonary Disease (COPD). This is a study randomized cross-over clinical trial and blind, in subjects with Chronic Obstructive Pulmonary Disease (COPD) according to criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) (FEV1 / FVC \<0.7 and FEV1 \<80% predicted) selected at the Clinical Hospital of the Federal University of Pernambuco (UFPE) and Otavio de Freitas General Hospital (HGOF). The investigators recruited 13 patients COPD (according to previous sample calculation) aged between 40 and 80 years, of both sexes. The first day was held evaluation of lung function, respiratory muscle strength, body composition, dyspnea index and functional capacity. On the second day was held evaluation of thoracoabdominal complex kinematics by plethysmography Optoelectronics (OEP) with Quiet Breathing (QB) or pursed-lips breathing (PLB). Lung volumes with 2 minutes with QB and 6 minutes PLB or only 6 minutes by QB as randomization were observed. Before and after performing the requested breathing pattern diaphragmatic mobility was observed by Ultrasonography (US) and requested the patient an Inspiratory Capacity maneuver (IC). The evaluator who performed the ultrasound was blinded as to the beginning of the breathing pattern of order performed by the patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

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

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

10 months

First QC Date

March 5, 2015

Last Update Submit

April 22, 2015

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseRespiratory mechanicsPlethysmographyDiaphragmRespiratory musclesBreathing exercises

Outcome Measures

Primary Outcomes (3)

  • Chest wall (Analysis of lung volumes)

    (L) by plethysmography optoelectronics.

    One day during eight minutes

  • Mobility diaphragmatic (mobility diaphragmatic (mm) by Ultrassonography)

    Analysis of mobility diaphragmatic (mm) by Ultrassonography.

    One day, before and after eight minutes of pursed lips breathing

  • Exercise tolerance (Glittre AVD-Test)

    Analysis by Glittre AVD-Test (capacity functional test) observing the test execution time (s).

    One day, for six minutes approximately. The test will be repeated after 20 minutes of rest.

Secondary Outcomes (1)

  • Dyspnea (Borg and MRC Scale)

    One day, before and after implementation of Glittre-ADL Test

Study Arms (1)

Quiet Breathing or Pursed Lips Breathing

EXPERIMENTAL

Free or natural breathing for six minutes.

Other: Pursed Lips BreathingOther: Quiet Breathing

Interventions

Pursed Lips Breathing for six minutes.

Quiet Breathing or Pursed Lips Breathing
Quiet Breathing or Pursed Lips Breathing

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD diagnosis with stage II-IV (GOLD),
  • Stable clinical condition (no exacerbation or hospital admission in the last four weeks preceding the study)
  • Absence of other disease that may potentially contribute to dyspnea (heart disease, congestive heart failure, neuromuscular diseases, severe postural changes)

You may not qualify if:

  • BMI\> 30 kg / m2
  • Musculoskeletal limitations
  • Use of oxygen therapy
  • Extreme discomfort during the procedure application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital

Recife, Pernambuco, 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

  • Armele D Andrade, Dra

    Universidade Federal de Pernambuco

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master

Study Record Dates

First Submitted

March 5, 2015

First Posted

April 23, 2015

Study Start

March 1, 2014

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

April 23, 2015

Record last verified: 2015-04

Locations