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

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Flutter
Chest Compression
Control
Impulse Oscillometric
Dyspnea scale
Acceptability and tolerance
Pulse oximetry
Difficulty sputum
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Respiratory System, Physical Therapy Modalities

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ribeirão Preto Medicine School, University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Flutter Intervention

Chest Compression Intervention

Crontrol Intervention

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Respiratory System Impedance
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.
Difficulty sputum
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.
Secretions weight
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.

Secondary Outcome Measures

Pulse oximetry
During therapy the patient will remain monitored with digital oximeter and the information will be recorded before and after the procedures
Acceptability and tolerance
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).
Dyspnea scale:
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).
Adhesiveness of expectorated secretion:
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.

Full Information

First Posted
July 3, 2015
Last Updated
February 21, 2017
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02509637
Brief Title
Acute Effects of a Flutter Device and Chest Wall Compression on Respiratory System Impedance in Bronchiectasis Patients
Official Title
Acute Effects of a Flutter Device and Chest Wall Compression on Respiratory System Impedance in Bronchiectasis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Respiratory System, Physical Therapy Modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flutter Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Chest Compression Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Crontrol Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Flutter
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Chest Compression
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Type
Other
Intervention Name(s)
Impulse Oscillometric
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dyspnea scale
Intervention Description
Dyspnea will be evaluated across the range Medical Research Council (MRC) for use in patients with chronic obstructive pulmonary disease in Brazil.
Intervention Type
Other
Intervention Name(s)
Acceptability and tolerance
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Pulse oximetry
Intervention Description
During therapy the patient will remain monitored with digital oximeter and the information will be recorded before and after the procedures
Intervention Type
Other
Intervention Name(s)
Difficulty sputum
Intervention Description
Patients inform the ease or difficulty sputum according to a scale of 1 to 5, where 1 = no difficulty and 5 = extremely difficult.
Primary Outcome Measure Information:
Title
Respiratory System Impedance
Description
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.
Time Frame
In the primary evaluation, and after seven and fourteen days.
Title
Difficulty sputum
Description
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.
Time Frame
In the primary evaluation, and after seven and fourteen days.
Title
Secretions weight
Description
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.
Time Frame
In the primary evaluation, and after seven and fourteen days.
Secondary Outcome Measure Information:
Title
Pulse oximetry
Description
During therapy the patient will remain monitored with digital oximeter and the information will be recorded before and after the procedures
Time Frame
In the primary evaluation, and after seven and fourteen days.
Title
Acceptability and tolerance
Description
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).
Time Frame
In the primary evaluation, and after seven and fourteen days.
Title
Dyspnea scale:
Description
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).
Time Frame
In the primary evaluation, and after seven and fourteen days.
Title
Adhesiveness of expectorated secretion:
Description
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.
Time Frame
In the primary evaluation, and after seven and fourteen days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ada C Gastaldi, PhD
Organizational Affiliation
Ribeirão Preto Medicine School - University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ribeirão Preto Medicine School, University of São Paulo
City
Ribeirão Preto
State/Province
SP
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
21641196
Citation
Tambascio J, de Souza LT, Lisboa RM, Passarelli Rde C, de Souza HC, Gastaldi AC. The influence of Flutter(R)VRP1 components on mucus transport of patients with bronchiectasis. Respir Med. 2011 Sep;105(9):1316-21. doi: 10.1016/j.rmed.2011.04.017.
Results Reference
background
PubMed Identifier
14680096
Citation
Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.
Results Reference
background
PubMed Identifier
19648517
Citation
Murray MP, Pentland JL, Turnbull K, MacQuarrie S, Hill AT. Sputum colour: a useful clinical tool in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Aug;34(2):361-4. doi: 10.1183/09031936.00163208.
Results Reference
background
PubMed Identifier
17132121
Citation
McCarren B, Alison JA, Herbert RD. Manual vibration increases expiratory flow rate via increased intrapleural pressure in healthy adults: an experimental study. Aust J Physiother. 2006;52(4):267-71. doi: 10.1016/s0004-9514(06)70006-x.
Results Reference
background
PubMed Identifier
17416150
Citation
Eaton T, Young P, Zeng I, Kolbe J. A randomized evaluation of the acute efficacy, acceptability and tolerability of flutter and active cycle of breathing with and without postural drainage in non-cystic fibrosis bronchiectasis. Chron Respir Dis. 2007;4(1):23-30. doi: 10.1177/1479972306074481.
Results Reference
result
PubMed Identifier
31138732
Citation
de Souza Simoni LH, Dos Santos DO, de Souza HCD, Baddini-Martinez JA, Santos MK, Gastaldi AC. Acute Effects of Oscillatory PEP and Thoracic Compression on Secretion Removal and Impedance of the Respiratory System in Non-Cystic Fibrosis Bronchiectasis. Respir Care. 2019 Jul;64(7):818-827. doi: 10.4187/respcare.06025. Epub 2019 May 28.
Results Reference
derived

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

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