Acute Effects of a Flutter Device and Chest Wall Compression on Respiratory System Impedance in Bronchiectasis Patients

February 21, 2017 updated by: Ada Clarice Gastaldi, University of Sao Paulo
Bronchiectasis is characterized pathologically by the abnormal and permanent dilation of bronchi caused mainly by the perpetuation of inflammation and impaired clearance of secretions. Physical therapy is essential in the treatment of these patients, using its various techniques and devices. The aim of this study is to evaluate the impedance of the respiratory system, by impulse oscillometry, after breathing exercises with chest compression or flutter in patients with bronchiectasis, considering that there are no results in the literature on the effect of these techniques in the small airways of these patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Bronchiectasis patients and healthy subjects will be evaluated before and after a 30 minutes session of control, breathing exercises with flutter valve, that is a device that produces oscillation and positive pressure during the expiratory phase, or chest compression, that is a manual manoeuvre in the right and left sides of the lower chest, all of them in a sitting position. The main outcome will be obtained by impulse oscillometry, that is a method to access large and small airways, to evaluate the resistance (R), reactance (X), reactance area (AX) and resonant frequency (Fres) of respiratory system for the whole breath and for inspiratory and expiratory phase. Additionally, will be analysed the dyspnea using the Medical Research Council scale; acceptability and tolerability scale; pulse oxymetry; difficulty of expectoration score; and volume, adhesivity and purulence of sputum.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
    • SP
      • Ribeirão Preto, SP, Brazil, 14049-900
        • Ribeirão Preto Medicine School, University of São Paulo

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged between 30 and 80 years
  • diagnosed with bronchiectasis not resulting from cystic fibrosis, defined by history and full clinical examination and confirmed by computed tomography.

Exclusion Criteria:

  • Chest pain
  • acute hemoptysis
  • recent history rib fracture and pneumothorax
  • respiratory infection in the last 4 weeks prior to study
  • cystic fibrosis
  • asthma
  • fistula.
  • chronic obstructive pulmonary disease

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Flutter Intervention
After initial evaluation, the subjects will perform breathing exercises with quiet inspiration and prolonged expiration on the device for thirty minutes, with breaks of one minute every four minutes. Immediately after the exercise will be performed new assessment against Impulse Oscillometry. Then patients will be kept for 30 minutes at rest and at the end will be applied the acceptability and tolerance scale and a third evaluation with Impulse Oscillometry. The secretions expectorated during the protocol will be evaluated for weight, adhesiveness and purulence.
Device: Flutter
Flutter is a small device, simple, like a plastic pipe with a mouthpiece at one end and a perforated cover on the other, containing a steel ball resting in a plastic cone inside. When the patient exhales through the flutter expiratory flow causes movement of the ball, creating an oscillatory positive pressure.
Other: Impulse Oscillometric
For this measure will be used IOS Jaeger (Jaeger, Wurzburg, Germany). to minimize the effect of the bad positioning of the tongue will use a mouth "free-flow", which contains a depressant for keeping the tongue in the mouth soil, stabilizing it and reducing oral resistance. Volunteers will support hands firmly on the cheeks to reduce the effect of oscillation thereof. The measures will be carried out with the volunteer sitting, using nasal, relaxed and your head in neutral clip, breathing normally through the mouthpiece to his lips tightly sealed to prevent air leaks.
Other: Dyspnea scale
Dyspnea will be evaluated across the range Medical Research Council (MRC) for use in patients with chronic obstructive pulmonary disease in Brazil.
Other: Acceptability and tolerance
patients will complete scales 1-7, 1: extremely and 7: none) on usefulness, ease to understand the instructions, easy to perform the exercises, degree of fatigue and discomfort
Device: Pulse oximetry
During therapy the patient will remain monitored with digital oximeter and the information will be recorded before and after the procedures
Other: Difficulty sputum
Patients inform the ease or difficulty sputum according to a scale of 1 to 5, where 1 = no difficulty and 5 = extremely difficult.
Active Comparator: Chest Compression Intervention
After initial evaluation, the subjects will be instructed to perform deep breaths between three quiet inspiration brought, and expiration will be accompanied by bilateral compression with the therapist's hands on the lower ribs during thirty minutes with one minute intervals of rest every four minutes. Immediately after the exercise will be performed new assessment against Impulse Oscillometry. Then patients will be kept for 30 minutes at rest and at the end will be applied the acceptability and tolerance scale and a third evaluation with Impulse Oscillometry. The secretions expectorated during the protocol will be evaluated for weight, adhesiveness and purulence.
Other: Impulse Oscillometric
For this measure will be used IOS Jaeger (Jaeger, Wurzburg, Germany). to minimize the effect of the bad positioning of the tongue will use a mouth "free-flow", which contains a depressant for keeping the tongue in the mouth soil, stabilizing it and reducing oral resistance. Volunteers will support hands firmly on the cheeks to reduce the effect of oscillation thereof. The measures will be carried out with the volunteer sitting, using nasal, relaxed and your head in neutral clip, breathing normally through the mouthpiece to his lips tightly sealed to prevent air leaks.
Other: Dyspnea scale
Dyspnea will be evaluated across the range Medical Research Council (MRC) for use in patients with chronic obstructive pulmonary disease in Brazil.
Other: Acceptability and tolerance
patients will complete scales 1-7, 1: extremely and 7: none) on usefulness, ease to understand the instructions, easy to perform the exercises, degree of fatigue and discomfort
Device: Pulse oximetry
During therapy the patient will remain monitored with digital oximeter and the information will be recorded before and after the procedures
Other: Difficulty sputum
Patients inform the ease or difficulty sputum according to a scale of 1 to 5, where 1 = no difficulty and 5 = extremely difficult.
Other: Chest Compression
Manual chest compression is based on the application of forces resulting from the action of respiratory muscles or physiotherapist manual action in order to increase the alveolar pressure creating a pressure gradient to promote change in pulmonary flow and volume.It consists of vigorous compression of the chest at the beginning of expiration or during expiration.
Active Comparator: Crontrol Intervention
After initial evaluation, patients will be remain seated quiet breathing without any guidance for thirty minutes. Immediately after this time will be held reassessment with Impulse Oscillometry. Then patients will be kept for 30 minutes at rest and at the end will be applied to acceptance and tolerance scale and a third evaluation with Impulse Oscillometry. The secretions expectorated during the protocol will be evaluated for wight, adhesiveness and purulence.
Other: Control
Other: Impulse Oscillometric
For this measure will be used IOS Jaeger (Jaeger, Wurzburg, Germany). to minimize the effect of the bad positioning of the tongue will use a mouth "free-flow", which contains a depressant for keeping the tongue in the mouth soil, stabilizing it and reducing oral resistance. Volunteers will support hands firmly on the cheeks to reduce the effect of oscillation thereof. The measures will be carried out with the volunteer sitting, using nasal, relaxed and your head in neutral clip, breathing normally through the mouthpiece to his lips tightly sealed to prevent air leaks.
Other: Dyspnea scale
Dyspnea will be evaluated across the range Medical Research Council (MRC) for use in patients with chronic obstructive pulmonary disease in Brazil.
Other: Acceptability and tolerance
patients will complete scales 1-7, 1: extremely and 7: none) on usefulness, ease to understand the instructions, easy to perform the exercises, degree of fatigue and discomfort
Device: Pulse oximetry
During therapy the patient will remain monitored with digital oximeter and the information will be recorded before and after the procedures
Other: Difficulty sputum
Patients inform the ease or difficulty sputum according to a scale of 1 to 5, where 1 = no difficulty and 5 = extremely difficult.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Respiratory System Impedance
Time Frame: In the primary evaluation, and after seven and fourteen days.
Will be evaluated the resistance (R), reactance (X), reactance area (AX) and resonance frequency (Fres) before, immediately after the intervention and after 30 minutes of rest in order of identifying changes in the components of resistance of airways of individuals.
In the primary evaluation, and after seven and fourteen days.
Difficulty sputum
Time Frame: In the primary evaluation, and after seven and fourteen days.
Patients inform the ease or difficulty in expectoration in accordance with a scale of 1 to 5, where 1 = no difficulty and 5 = extremely difficult. (Burioka, 1998). The scale will be applied at baseline and always after the intervention to assess whether there is difference in the difficulty of sputum between sessions.
In the primary evaluation, and after seven and fourteen days.
Secretions weight
Time Frame: In the primary evaluation, and after seven and fourteen days.
The secretions are collected in the universal and heavy collectors on a precision balance.They will be evaluated in the total weight measurements and a dry weight and wet mucus. The weight of mucus of each interventions are compared to determine a technique with improved efficiency for removal of secretions.
In the primary evaluation, and after seven and fourteen days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pulse oximetry
Time Frame: In the primary evaluation, and after seven and fourteen days.
During therapy the patient will remain monitored with digital oximeter and the information will be recorded before and after the procedures
In the primary evaluation, and after seven and fourteen days.
Acceptability and tolerance
Time Frame: In the primary evaluation, and after seven and fourteen days.
30 minutes after the treatment session or control, patients will complete scales 1-7, 1: extremely and 7: none) on usefulness, ease to understand the instructions, easy to perform the exercises, degree of fatigue and discomfort (adapted EATON, 2007).
In the primary evaluation, and after seven and fourteen days.
Dyspnea scale:
Time Frame: In the primary evaluation, and after seven and fourteen days.
Dyspnea will be evaluated across the range Medical Research Council (MRC) for use in patients with chronic obstructive pulmonary disease in Brazil. The MRC scale comprises only five items, and the patient chooses the item corresponding to as dyspnea limits their activities of daily living. The patient reports its subjective degree of dyspnea choosing a value ranging from 1 to 5, with 1 (only suffers from shortness of breath during intense exercise), 2 (suffers from shortness of breath when walking briskly or climbing a slight slope) 3 (walks slower than people of the same age because of breathlessness or has to stop for breath even when walking slowly), 4 (stops for breath after walking less than 100 m or after a few minutes) and 5 (feel so short of breath that does not go over the house, or feel short of breath when getting dressed) (KOLEVIS et al., 2008).
In the primary evaluation, and after seven and fourteen days.
Adhesiveness of expectorated secretion:
Time Frame: In the primary evaluation, and after seven and fourteen days.
Immediately after the separation of secretion with saliva, mucus will be evaluated for its adhesion award a note according to visual scale described by Lopez-Vidriero et al., 1973. Test samples giving the adhesive index between 1 (fully adhered) and 2 (small movement under gravity) will be classified as adhesive and between 3 (slow moving mass) and 4 (easy handling) will be classified as non-adhesive.
In the primary evaluation, and after seven and fourteen days.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • USP 2015-3

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