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
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.
Study Type
Interventional
Primary Outcome
Respiratory System Impedance
Secondary Outcome
Pulse oximetry
Condition
Bronchiectasis
Intervention
Flutter
Study Arms / Comparison Groups
Flutter Intervention
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
40
Start Date
August 2015
Completion Date
September 2016
Primary Completion Date
September 2016
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
Gender
All
Ages
30 Years - 80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Ada C Gastaldi, PhD, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT02509637
Organization ID
USP 2015-3
Responsible Party
Principal Investigator
Study Sponsor
University of Sao Paulo
Study Sponsor
Ada C Gastaldi, PhD, Principal Investigator, Ribeirão Preto Medicine School - University of São Paulo
Verification Date
February 2017