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

NCT04234789 | Completed

• 2 other identifiers: SDC 4245/15/0722015/14638-2
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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

Conditions

Bronchiectasis Adult

Keywords

dynamic hyperinflation; oscillometry; pletysmography

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 (single visit)

Study Arms (1)

Cardiopulmonary exercising test

OTHER

All patients underwent to diagnostic tests protocol

Diagnostic Test: cardiopulmonary exercise testing with dynamic hyperinflation maneuver; Diagnostic Test: spirometry; Diagnostic Test: pletysmography; Diagnostic Test: forced oscillometry technique

Interventions

cardiopulmonary exercise testing with dynamic hyperinflation maneuver DIAGNOSTIC_TEST

test performed as recommended by ATS guidelines

Cardiopulmonary exercising test

spirometry DIAGNOSTIC_TEST

test performed as recommended by ATS guidelines

Cardiopulmonary exercising test

pletysmography DIAGNOSTIC_TEST

test performed as recommended by ATS guidelines

Cardiopulmonary exercising test

forced oscillometry technique DIAGNOSTIC_TEST

test performed as recommended by ATS guidelines

Cardiopulmonary exercising test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Interventions

Exercise Test; Spirometry

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Rodrigo A Athanazio, MD, PhD

  Medical Assistant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-sectional study. All patients underwent to diagnostic tests protocol.

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 21, 2020
• Study Start: May 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: October 1, 2017
• Last Updated: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)