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Predictors of Physical Activity Performance and Dynamic Hyperinflation in Patients With Bronchiectasis

Primary Purpose

Bronchiectasis Adult

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
cardiopulmonary exercise testing with dynamic hyperinflation maneuver
spirometry
pletysmography
forced oscillometry technique
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bronchiectasis Adult focused on measuring dynamic hyperinflation, oscillometry, pletysmography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients over 18 years of age followed at the Bronchiectasis Outpatient Clinic of the Pulmonology Department of the University of São Paulo who meet the following criteria will be included in the study:

  • Have a diagnosis of bronchiectasis confirmed by chest CT.
  • Sign the free and informed consent form for participation in the study.

Exclusion Criteria:

  • Diagnosis of Cystic Fibrosis.
  • Asthma diagnosis.
  • Diagnosis of COPD.
  • Pregnancy
  • Inability to perform pulmonary function test.
  • Recent treatment (<30 days) of infectious exacerbation with oral corticosteroid or antibiotic.
  • Contraindication to exercise tests.
  • Exercise limitation not related to lung disease (orthopedic or cardiovascular problems).
  • History of pulmonary resection.
  • Current smoking or previous smoking load greater than 10 years / pack.
  • Patients on prolonged home oxygen therapy.
  • Allergic bronchopulmonary aspergillosis.
  • Active mycobacteriosis.

Sites / Locations

  • University of São Paulo

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cardiopulmonary exercising test

Arm Description

All patients underwent to diagnostic tests protocol

Outcomes

Primary Outcome Measures

Prevalence of dynamic hyperinflation during cardiopulmonary exercise testing
During cardiopulmonary exercising testing, patients were asked to perform inspiratory capacity maneuvers every 2 minutes. Dynamic hyperinflation was considered as present when the patient had a reduction of 10% or more of the inspiratory capacity.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2020
Last Updated
January 15, 2020
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04234789
Brief Title
Predictors of Physical Activity Performance and Dynamic Hyperinflation in Patients With Bronchiectasis
Official Title
Predictors of Physical Activity Performance and Dynamic Hyperinflation in Patients With Bronchiectasis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Bronchiectasis is characterized by abnormal and irreversible airway dilation and can be caused by a wide variety of diseases, including congenital diseases, mechanical bronchial obstruction, respiratory infections, and immunodeficiencies. It is a chronic condition with varying severity. Although some patients remain stable for years, the natural history of the disease is progressive deterioration of lung function, Regarding pulmonary function in this group of patients, there are several changes. In a study of 304 patients with bronchiectasis, spirometry was performed in 274 patients. Most of these patients (46.7%) had an obstructive ventilatory disorder, a small percentage of patients (8%) had restrictive disorder and a portion of patients (23.7%) had mixed disorder. The remaining patients (21.5%) had normal spirometry. Dyspnea in this situation occurs due to neuromechanical dissociation, that is, the respiratory drive is increased, but the inspiratory muscles show a reduction in their ability to produce effective ventilation. Besides not knowing if dynamic hyperinflation (DH) is present in patients with bronchiectasis, the mechanism responsible for its onset is also unknown. Exercise capacity is reduced in many patients with bronchiectasis, but there is little information about the exercise response in this population. The primary objective of this study is to evaluate the prevalence of dynamic hyperinflation in patients with bronchiectasis
Detailed Description
Bronchiectasis is characterized by abnormal and irreversible airway dilation and can be caused by a wide variety of diseases, including congenital diseases, mechanical bronchial obstruction, respiratory infections, and immunodeficiencies. It is a chronic condition with varying severity. Although some patients remain stable for years, the natural history of the disease is progressive deterioration of lung function, chronic respiratory failure, pulmonary hypertension, and right ventricular failure. Bronchiectasis is a consequence of injury and remodeling with destruction of structural components of the bronchial wall by inflammation and chronic or recurrent infection.The best-known model of developing bronchiectasis is the hypothesis of Cole's vicious cycle. An environmental insult associated with a genetic predisposition impairs mucociliary transport resulting in persistence of microorganisms in the bronchial tree. The infection causes inflammation resulting in tissue damage and further impairing ciliary motility. This leads to further infection, inflammation and lung damage.The patient with bronchiectasis has a cough, chronic sputum, hemoptysis and progressive dyspnea. The clinical course is marked by recurrent infectious exacerbations and over time the patient develops progressive airway obstruction with functional loss. Regarding pulmonary function in this group of patients, there are several changes. In a study of 304 patients with bronchiectasis, spirometry was performed in 274 patients. Most of these patients (46.7%) had an obstructive ventilatory disorder, a small percentage of patients (8%) had restrictive disorder and a portion of patients (23.7%) had mixed disorder. The remaining patients (21.5%) had normal spirometry. Dynamic hyperinflation (DH) is characterized by progressive air trapping, which leads to increased end-expiratory lung volume (equivalent to dynamic functional residual capacity) associated with decreased inspiratory capacity (IC) in situations where ventilation is increased, such as exercise. . Dynamic hyperinflation is one of the mechanisms responsible for dyspnea and reduced exercise tolerance in patients with conditions that lead to expiratory flow limitation, such as asthma and COPD. Studies evaluating dynamic hyperinflation were performed in chronic obstructive pulmonary disease (COPD) patients, demonstrating that the progressive reduction of IC during the maximal or constant load test, on the treadmill or on the cycle ergometer, or through measurements performed before and after the test. The 6-minute walk showed a good correlation with the degree of dyspnea (including the Borg scale) and lower exercise tolerance . Since the total lung capacity (TLC) does not vary or has little non-significant variation during exercise or after bronchodilation, the reduction in IC reflects increased end-expiratory lung volume (VPFE) . In COPD patients, the prevalence of DH is high, around 80% in patients with an average forced expiratory volume in first second (FEV1) of 37%, according to a 2001 study. Asthmatic patients, even with normal spirometry, stable clinical status and no exercise-induced asthma may present limitation to expiratory flow and dynamic hyperinflation during exertion, justifying the presence of dyspnea and less ability to perform exercises In individuals with expiratory flow limitation, the additional elevation of tidal volume (VT) on exertion is limited because operative lung volumes are progressively closer to TLC, in a higher region of the pressure volume curve, where pulmonary compliance is lower. Secondarily, there is a reduction in inspiratory reserve volume (VRI) and, when this volume approaches 500 ml (critical VRI), dyspnea increases considerably, being referred to as inspiratory difficulty. The increase in minute volume is now determined by increased respiratory rate (RR), which further aggravates the situation due to reduced expiratory time (ET), with less time available for elimination of previously inhaled air volume, causing progressive air trapping and worsening pulmonary hyperinflation, entering a vicious cycle (9,10,13,21). Additionally, this mechanism promotes increased elastic overload on the inspiratory muscles by shortening the fibers, reducing their capacity to generate force, determining increased respiratory work, oxygen consumption and the risk of muscle fatigue, as well as adverse hemodynamic effects . Dyspnea in this situation occurs due to neuromechanical dissociation, that is, the respiratory drive is increased, but the inspiratory muscles show a reduction in their ability to produce effective ventilation. The most commonly used option for dynamic hyperinflation assessment is the serial measurement of IC during maneuvers that promote hyperventilation, such as by performing an incremental or constant-load stress test on the cycle ergometer or treadmill, performing the 6-minute test.. Besides not knowing if DH is present in patients with bronchiectasis, the mechanism responsible for its onset is also unknown. Exercise capacity is reduced in many patients with bronchiectasis, but there is little information about the exercise response in this population. A study was published in 2009 investigating exercise capacity and possible exercise limiting factors in patients with bilateral bronchiectasis. Approximately 50% of patients had reduced exercise capacity, and this was observed in those who had expiratory flow limitation and reduced FEV1 values. Ventilatory limitation, desaturation, and impaired oxygen transport or utilization appear to be the main factors involved in exercise limitation. However, the sample was very small (15 patients) and no DH evaluation was performed. There are no studies evaluating the presence of DH in patients with bronchiectasis and there are few studies on the physiology of dyspnea in this population. DH is an important mechanism of exercise limitation in COPD and may explain exercise dyspnea and decreased exercise tolerance in patients with bronchiectasis. Study hypothesis: Dynamic hyperinflation is present in patients with bronchiectasis. Objectives: Primary - To evaluate the prevalence of dynamic hyperinflation in patients with bronchiectasis Secondary Evaluate aerobic capacity in a population with bronchiectasis To evaluate predictors of dynamic hyperinflation and aerobic limitation in patients with bronchiectasis. Anthropometric data, clinical, functional and tomographic variables will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis Adult
Keywords
dynamic hyperinflation, oscillometry, pletysmography

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cross-sectional study. All patients underwent to diagnostic tests protocol.
Masking
None (Open Label)
Allocation
N/A
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiopulmonary exercising test
Arm Type
Other
Arm Description
All patients underwent to diagnostic tests protocol
Intervention Type
Diagnostic Test
Intervention Name(s)
cardiopulmonary exercise testing with dynamic hyperinflation maneuver
Intervention Description
test performed as recommended by ATS guidelines
Intervention Type
Diagnostic Test
Intervention Name(s)
spirometry
Intervention Description
test performed as recommended by ATS guidelines
Intervention Type
Diagnostic Test
Intervention Name(s)
pletysmography
Intervention Description
test performed as recommended by ATS guidelines
Intervention Type
Diagnostic Test
Intervention Name(s)
forced oscillometry technique
Intervention Description
test performed as recommended by ATS guidelines
Primary Outcome Measure Information:
Title
Prevalence of dynamic hyperinflation during cardiopulmonary exercise testing
Description
During cardiopulmonary exercising testing, patients were asked to perform inspiratory capacity maneuvers every 2 minutes. Dynamic hyperinflation was considered as present when the patient had a reduction of 10% or more of the inspiratory capacity.
Time Frame
Day 1 (single visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years of age followed at the Bronchiectasis Outpatient Clinic of the Pulmonology Department of the University of São Paulo who meet the following criteria will be included in the study: Have a diagnosis of bronchiectasis confirmed by chest CT. Sign the free and informed consent form for participation in the study. Exclusion Criteria: Diagnosis of Cystic Fibrosis. Asthma diagnosis. Diagnosis of COPD. Pregnancy Inability to perform pulmonary function test. Recent treatment (<30 days) of infectious exacerbation with oral corticosteroid or antibiotic. Contraindication to exercise tests. Exercise limitation not related to lung disease (orthopedic or cardiovascular problems). History of pulmonary resection. Current smoking or previous smoking load greater than 10 years / pack. Patients on prolonged home oxygen therapy. Allergic bronchopulmonary aspergillosis. Active mycobacteriosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo A Athanazio, MD, PhD
Organizational Affiliation
Medical Assistant
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Predictors of Physical Activity Performance and Dynamic Hyperinflation in Patients With Bronchiectasis

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