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Clinical Trials/NCT04234789
NCT04234789CompletedNot Applicable

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

University of Sao Paulo General Hospital2 sites in 1 country208 target enrollmentStarted: May 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
208
Locations
2
Primary Endpoint
Prevalence of dynamic hyperinflation during cardiopulmonary exercise testing

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Prevalence of dynamic hyperinflation during cardiopulmonary exercise testing

Time Frame: Day 1 (single visit)

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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