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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • USP 2016-1

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