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

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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

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:

        1. Primary

           - To evaluate the prevalence of dynamic hyperinflation in patients with bronchiectasis

        2. 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.
    


Study Type

Interventional


Primary Outcome

Prevalence of dynamic hyperinflation during cardiopulmonary exercise testing


Condition

Bronchiectasis Adult

Intervention

cardiopulmonary exercise testing with dynamic hyperinflation maneuver

Study Arms / Comparison Groups

 Cardiopulmonary exercising test
Description:  All patients underwent to diagnostic tests protocol

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

Diagnostic Test

Estimated Enrollment

208

Start Date

May 2014

Completion Date

October 2017

Primary Completion Date

May 2014

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Rodrigo A Athanazio, MD, PhD, , 

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT04234789

Organization ID

SDC 4245/15/072

Secondary IDs

2015/14638-2

Responsible Party

Sponsor

Study Sponsor

University of Sao Paulo General Hospital

Collaborators

 FAPESP - Fundação de Apoio à Pesquisa do Estado de São Paulo

Study Sponsor

Rodrigo A Athanazio, MD, PhD, Principal Investigator, Medical Assistant


Verification Date

January 2020