- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02424331
Effect of Pursed Lips Breathing on Chest Wall, Mobility Diaphragmatic and Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease
April 22, 2015 updated by: Marcely Kellyane Florenço Barros, Universidade Federal de Pernambuco
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
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
-
-
Pernambuco
-
Recife, Pernambuco, Brazil
- Clinical Hospital
-
-
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 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)
Exclusion Criteria:
- BMI> 30 kg / m2
- Musculoskeletal limitations
- Use of oxygen therapy
- Extreme discomfort during the procedure application
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
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Quiet Breathing or Pursed Lips Breathing
Free or natural breathing for six minutes.
|
Pursed Lips Breathing for six minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chest wall (Analysis of lung volumes)
Time Frame: One day during eight minutes
|
(L) by plethysmography optoelectronics.
|
One day during eight minutes
|
Mobility diaphragmatic (mobility diaphragmatic (mm) by Ultrassonography)
Time Frame: One day, before and after eight minutes of pursed lips breathing
|
Analysis of mobility diaphragmatic (mm) by Ultrassonography.
|
One day, before and after eight minutes of pursed lips breathing
|
Exercise tolerance (Glittre AVD-Test)
Time Frame: One day, for six minutes approximately. The test will be repeated after 20 minutes of rest.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea (Borg and MRC Scale)
Time Frame: One day, before and after implementation of Glittre-ADL Test
|
Assessed by Borg and MRC Scale (Medical Research Council).
|
One day, before and after implementation of Glittre-ADL Test
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Armele D Andrade, Dra, Universidade Federal de Pernambuco
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, 2014
Primary Completion (ACTUAL)
January 1, 2015
Study Completion (ACTUAL)
March 1, 2015
Study Registration Dates
First Submitted
March 5, 2015
First Submitted That Met QC Criteria
April 22, 2015
First Posted (ESTIMATE)
April 23, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
April 23, 2015
Last Update Submitted That Met QC Criteria
April 22, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19309213.3.0000.5208
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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