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Pulmonary Rehabilitation in Non-Cystic Fibrosis Bronchiectasis

Primary Purpose

Bronchiectasis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Control
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Bronchiectasis, Mucociliary clearance, Exercise, Inflammation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ribeirão Preto Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Sham Comparator

Sham Comparator

Arm Label

Bronchiectasis Pulmonary Rehabilitation

Healthy Pulmonary Rehabilitation

Bronchiectasis Group Control

Healthy Group Control

Arm Description

The volunteers will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, for 12 weeks.

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.

The volunteers with bronchiectasis will be informed only about the benefits of physical activities

Volunteers healthy will be informed only about the benefits of physical activities

Outcomes

Primary Outcome Measures

Mucociliary transport in vivo
This measurement it will be evaluated by the saccharine transport time, according to methodology (Stanley, 1984)

Secondary Outcome Measures

Mucociliary transport in vitro
This measurement it will be evaluated by the transport properties in vitro, according to methodology (Trindade, 1997)
Quality of Life in Bronchiectasis
For this evaluation the investigators will use the Quality of life in bronchiectasis (QOLB) (Chalmers, 2014)
Cough Impact Assessment
For this evaluation the investigators will use the Leicester Cough Questionnaire (LCQ), (Murray, 2009).
Health-Related Quality of Life
For this evaluation the investigators will use the Short Form Health Survey (SF-36) (Ware, 1992)
Impulse Oscillometry System (IOS)
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).
Pulmonary Function Test
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%).
Six Minute Walking Test
Patients walk through a 30 meter corridor faster than they can for 6 minutes, according to ATS considerations.
Maximal Static Respiratory Pressures
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.
Viscosity
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)
Elasticity
To perform this measure, it is been used a capillary viscometer dual-chamber is used for measuring elasticity of bronchial mucus (Kim, 1988)
Exhaled breath condensate
It will be collected as previously described (Koczulla et al., 2009).
Exhaled Nitric Oxide Fraction (FeNO)
It will be performed according to protocol defined by the American Thoracic Society (ATS, 2011), using the device NioxMino™.
Cytokine Analysis TNF-α
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.
Cytokine Analysis IL-6
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.
Cytokine Analysis IL-10
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.

Full Information

First Posted
May 19, 2016
Last Updated
August 16, 2017
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02823587
Brief Title
Pulmonary Rehabilitation in Non-Cystic Fibrosis Bronchiectasis
Official Title
Effects of Pulmonary Rehabilitation on Secretion Transport, Inflammation and Respiratory System Strength and Quality of Life in Patients With Bronchiectasis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Bronchiectasis, Mucociliary clearance, Exercise, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bronchiectasis Pulmonary Rehabilitation
Arm Type
Experimental
Arm Description
The volunteers will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, for 12 weeks.
Arm Title
Healthy Pulmonary Rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Bronchiectasis Group Control
Arm Type
Sham Comparator
Arm Description
The volunteers with bronchiectasis will be informed only about the benefits of physical activities
Arm Title
Healthy Group Control
Arm Type
Sham Comparator
Arm Description
Volunteers healthy will be informed only about the benefits of physical activities
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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
Primary Outcome Measure Information:
Title
Mucociliary transport in vivo
Description
This measurement it will be evaluated by the saccharine transport time, according to methodology (Stanley, 1984)
Time Frame
Through study completion, an average of 2 years.
Secondary Outcome Measure Information:
Title
Mucociliary transport in vitro
Description
This measurement it will be evaluated by the transport properties in vitro, according to methodology (Trindade, 1997)
Time Frame
Through study completion, an average of 2 years.
Title
Quality of Life in Bronchiectasis
Description
For this evaluation the investigators will use the Quality of life in bronchiectasis (QOLB) (Chalmers, 2014)
Time Frame
Through study completion, an average of 2 years.
Title
Cough Impact Assessment
Description
For this evaluation the investigators will use the Leicester Cough Questionnaire (LCQ), (Murray, 2009).
Time Frame
Through study completion, an average of 2 years.
Title
Health-Related Quality of Life
Description
For this evaluation the investigators will use the Short Form Health Survey (SF-36) (Ware, 1992)
Time Frame
Through study completion, an average of 2 years.
Title
Impulse Oscillometry System (IOS)
Description
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).
Time Frame
Through study completion, an average of 2 years.
Title
Pulmonary Function Test
Description
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%).
Time Frame
Through study completion, an average of 2 years.
Title
Six Minute Walking Test
Description
Patients walk through a 30 meter corridor faster than they can for 6 minutes, according to ATS considerations.
Time Frame
Through study completion, an average of 2 years.
Title
Maximal Static Respiratory Pressures
Description
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.
Time Frame
Through study completion, an average of 2 years.
Title
Viscosity
Description
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)
Time Frame
Through study completion, an average of 2 years.
Title
Elasticity
Description
To perform this measure, it is been used a capillary viscometer dual-chamber is used for measuring elasticity of bronchial mucus (Kim, 1988)
Time Frame
Through study completion, an average of 2 years.
Title
Exhaled breath condensate
Description
It will be collected as previously described (Koczulla et al., 2009).
Time Frame
Through study completion, an average of 2 years
Title
Exhaled Nitric Oxide Fraction (FeNO)
Description
It will be performed according to protocol defined by the American Thoracic Society (ATS, 2011), using the device NioxMino™.
Time Frame
Through study completion, an average of 2 years
Title
Cytokine Analysis TNF-α
Description
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.
Time Frame
Through study completion, an average of 2 years
Title
Cytokine Analysis IL-6
Description
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.
Time Frame
Through study completion, an average of 2 years
Title
Cytokine Analysis IL-10
Description
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.
Time Frame
Through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ada C Gastaldi, PhD
Phone
55 16 33150473
Email
ada@fmrp.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ada C Gastaldi, PhD
Organizational Affiliation
Ribeirão Preto Medicine School - University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ribeirão Preto Medical School
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ada C Gastaldi, Phd
Email
ada@fmrp.usp.br

12. IPD Sharing Statement

Citations:
PubMed Identifier
24328736
Citation
Chalmers JD, Goeminne P, Aliberti S, McDonnell MJ, Lonni S, Davidson J, Poppelwell L, Salih W, Pesci A, Dupont LJ, Fardon TC, De Soyza A, Hill AT. The bronchiectasis severity index. An international derivation and validation study. Am J Respir Crit Care Med. 2014 Mar 1;189(5):576-85. doi: 10.1164/rccm.201309-1575OC.
Results Reference
background
PubMed Identifier
6691910
Citation
Stanley P, MacWilliam L, Greenstone M, Mackay I, Cole P. Efficacy of a saccharin test for screening to detect abnormal mucociliary clearance. Br J Dis Chest. 1984 Jan;78(1):62-5.
Results Reference
background
PubMed Identifier
22947443
Citation
Mandal P, Sidhu MK, Kope L, Pollock W, Stevenson LM, Pentland JL, Turnbull K, Mac Quarrie S, Hill AT. A pilot study of pulmonary rehabilitation and chest physiotherapy versus chest physiotherapy alone in bronchiectasis. Respir Med. 2012 Dec;106(12):1647-54. doi: 10.1016/j.rmed.2012.08.004. Epub 2012 Sep 1.
Results Reference
background
PubMed Identifier
18094814
Citation
Trindade SH, de Mello JF Jr, Mion Ode G, Lorenzi-Filho G, Macchione M, Guimaraes ET, Saldiva PH. Methods for studying mucociliary transport. Braz J Otorhinolaryngol. 2007 Sep-Oct;73(5):704-12. doi: 10.1016/s1808-8694(15)30133-6.
Results Reference
background
PubMed Identifier
19703285
Citation
Koczulla R, Dragonieri S, Schot R, Bals R, Gauw SA, Vogelmeier C, Rabe KF, Sterk PJ, Hiemstra PS. Comparison of exhaled breath condensate pH using two commercially available devices in healthy controls, asthma and COPD patients. Respir Res. 2009 Aug 24;10(1):78. doi: 10.1186/1465-9921-10-78.
Results Reference
background

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Pulmonary Rehabilitation in Non-Cystic Fibrosis Bronchiectasis

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