Pulmonary Rehabilitation in Non-Cystic Fibrosis Bronchiectasis

August 16, 2017 updated by: Ada Clarice Gastaldi, University of Sao Paulo

Effects of Pulmonary Rehabilitation on Secretion Transport, Inflammation and Respiratory System Strength and Quality of Life in Patients With Bronchiectasis

The purpose of this study is to assess the effect of pulmonary rehabilitation on the transport of secretions, inflammation and respiratory resistance, and its repercussions on the quality of life in patients with bronchiectasis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Bronchiectasis is characterized by pathological and irreversible dilation of bronchi caused by the inefficient removal of secretions and microorganisms and the perpetuation of inflammatory processes induced by chronic or recurrent infections, causing more damage to the airways that result in infections, and greater lesion airways and lung parenchyma. Pulmonary rehabilitation in people with bronchiectasis aims to improve exercise capacity, through effects on aerobic capacity and peripheral muscles, and to improve disease control and quality of life. The aim this study is to evaluate the effects of pulmonary rehabilitation on the transport of secretions, inflammation and respiratory resistance, and its repercussions on the quality of life in patients with bronchiectasis. In this study 60 volunteers, of both sexes, aged between 18-60 years, adequate the inclusion criteria, which will be assessed by lung function tests, the saccharin transport time, the inflammatory markers in the airways, the respiratory system resistance and quality of life scales. Volunteers will be randomly divided in pulmonary rehabilitation (PRG) and control groups (CG) that will be subdivided in bronchiectasis and healthy subgroups. In the PRG group they will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, while CG will be informed about the benefits of physical activities. All volunteers will be evaluated after 8 weeks of the baseline and at the end of the research. Data evolution will be collected from medical records and notes of the medical team and physical therapy that will follow the routine of these participants

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ada C Gastaldi, PhD
  • Phone Number: 55 16 33150473
  • Email: ada@fmrp.usp.br

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • Recruiting
        • Ribeirão Preto Medical School
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinically stable patients
  • both sexes
  • aged between 18-60 years
  • not due to cystic fibrosis bronchiectasis diagnosis
  • non smokers
  • no pulmonary disease

Exclusion Criteria:

  • asthma or other restrictive conditions
  • smokers assets
  • decompensated cardiovascular and metabolic diseases, neuromuscular or musculoskeletal that impede the realization of the Protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bronchiectasis Pulmonary Rehabilitation
The volunteers will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, for 12 weeks.
Other: Pulmonary Rehabilitation
The exercise program will consist of an individual exercise prescription on the treadmill or bike, the initial intensity of 85% VO2max and active exercises or active-resistance for upper and lower limbs according to the capacity of each volunteer.
Experimental: Healthy Pulmonary Rehabilitation
In this arm, the volunteers healthy will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, for 12 weeks.
Other: Pulmonary Rehabilitation
The exercise program will consist of an individual exercise prescription on the treadmill or bike, the initial intensity of 85% VO2max and active exercises or active-resistance for upper and lower limbs according to the capacity of each volunteer.
Sham Comparator: Bronchiectasis Group Control
The volunteers with bronchiectasis will be informed only about the benefits of physical activities
Other: Control
No supervised exercise session, only will be informed at the beginning of the study to perform thirty minutes of physical activity of moderate intensity several days a week is associated with health benefits
Sham Comparator: Healthy Group Control
Volunteers healthy will be informed only about the benefits of physical activities
Other: Control
No supervised exercise session, only will be informed at the beginning of the study to perform thirty minutes of physical activity of moderate intensity several days a week is associated with health benefits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mucociliary transport in vivo
Time Frame: Through study completion, an average of 2 years.
This measurement it will be evaluated by the saccharine transport time, according to methodology (Stanley, 1984)
Through study completion, an average of 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mucociliary transport in vitro
Time Frame: Through study completion, an average of 2 years.
This measurement it will be evaluated by the transport properties in vitro, according to methodology (Trindade, 1997)
Through study completion, an average of 2 years.
Quality of Life in Bronchiectasis
Time Frame: Through study completion, an average of 2 years.
For this evaluation the investigators will use the Quality of life in bronchiectasis (QOLB) (Chalmers, 2014)
Through study completion, an average of 2 years.
Cough Impact Assessment
Time Frame: Through study completion, an average of 2 years.
For this evaluation the investigators will use the Leicester Cough Questionnaire (LCQ), (Murray, 2009).
Through study completion, an average of 2 years.
Health-Related Quality of Life
Time Frame: Through study completion, an average of 2 years.
For this evaluation the investigators will use the Short Form Health Survey (SF-36) (Ware, 1992)
Through study completion, an average of 2 years.
Impulse Oscillometry System (IOS)
Time Frame: Through study completion, an average of 2 years.
To perform this measure, it is been used Jaeger® IOS(Jaeger, Wurzburg, Germany) with daily volume and resistance calibration. The parameters are calculated at frequencies between 5 and 35 hertz, and will be analyzed the following parameters in this test: resistance (R), reactance (X), reactance area (AX) and resonant frequency (Fres).
Through study completion, an average of 2 years.
Pulmonary Function Test
Time Frame: Through study completion, an average of 2 years.
This test is realized by using KoKo Spirometer™ according American Thoracic Society (ATS)/European Respiratory Society (ATS)recommendations. The analyzed parameters in this test are: forced vital capacity (FVC), Forced Expiratory Volume in the First Second (FEV1), FEV1/FVC and forced expiratory flow (FEF25-75%).
Through study completion, an average of 2 years.
Six Minute Walking Test
Time Frame: Through study completion, an average of 2 years.
Patients walk through a 30 meter corridor faster than they can for 6 minutes, according to ATS considerations.
Through study completion, an average of 2 years.
Maximal Static Respiratory Pressures
Time Frame: Through study completion, an average of 2 years.
It has beem used a digital manometer (MVD300, Global Med, São Paulo, Brazil) with graduation ranging from 0 to ± 300 centimeters of water (cmH2O) and adjusted to a rigid mouthpiece, following the proposed model by Black and Hyatt in 1969.
Through study completion, an average of 2 years.
Viscosity
Time Frame: Through study completion, an average of 2 years.
To perform this measure, it is been used a capillary viscometer dual-chamber is used for measuring viscosity of bronchial mucus (Barnett et al, 1970)
Through study completion, an average of 2 years.
Elasticity
Time Frame: Through study completion, an average of 2 years.
To perform this measure, it is been used a capillary viscometer dual-chamber is used for measuring elasticity of bronchial mucus (Kim, 1988)
Through study completion, an average of 2 years.
Exhaled breath condensate
Time Frame: Through study completion, an average of 2 years
It will be collected as previously described (Koczulla et al., 2009).
Through study completion, an average of 2 years
Exhaled Nitric Oxide Fraction (FeNO)
Time Frame: Through study completion, an average of 2 years
It will be performed according to protocol defined by the American Thoracic Society (ATS, 2011), using the device NioxMino™.
Through study completion, an average of 2 years
Cytokine Analysis TNF-α
Time Frame: Through study completion, an average of 2 years
The tumor necrosis factor-alpha concentrations (TNF-α) in the nasal lavage fluid(NFL) (samples will be determined using immunohistochemistry high sensitivity assays(ELISA), which will be performed according to the instructions the kit supplier.
Through study completion, an average of 2 years
Cytokine Analysis IL-6
Time Frame: Through study completion, an average of 2 years
The interleukins(IL) - IL-6 in the NFL samples will be determined using immunohistochemistry high sensitivity assays(ELISA), which will be performed according to the instructions the kit supplier.
Through study completion, an average of 2 years
Cytokine Analysis IL-10
Time Frame: Through study completion, an average of 2 years
The interleukins - IL-10 in the NFL samples will be determined using immunohistochemistry high sensitivity assays(ELISA), which will be performed according to the instructions the kit supplier.
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

May 19, 2016

First Submitted That Met QC Criteria

July 5, 2016

First Posted (Estimate)

July 6, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USP 2016-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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