Pulmonary Rehabilitation in Non-Cystic Fibrosis Bronchiectasis

Not Applicable

• Conditions: Bronchiectasis
• Interventions: Other: Control; Other: Pulmonary Rehabilitation

• Registration Number: NCT02823587
• Lead Sponsor: University of Sao Paulo

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-05-19
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-06
• Status Verified: 2016-12
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21
• Primary Completion: 2018-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Group Control	Control	Volunteers healthy will be informed only about the benefits of physical activities
Bronchiectasis Pulmonary Rehabilitation	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.
Healthy Pulmonary Rehabilitation	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.
Bronchiectasis Group Control	Control	The volunteers with bronchiectasis will be informed only about the benefits of physical activities

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Viscosity	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)
Exhaled breath condensate	Through study completion, an average of 2 years	It will be collected as previously described (Koczulla et al., 2009).
Exhaled Nitric Oxide Fraction (FeNO)	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™.
Cytokine Analysis TNF-α	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.
Cytokine Analysis IL-6	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.
Maximal Static Respiratory Pressures	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.
Elasticity	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)
Cytokine Analysis IL-10	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.
Mucociliary transport in vitro	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)
Six Minute Walking Test	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.
Impulse Oscillometry System (IOS)	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).
Quality of Life in Bronchiectasis	Through study completion, an average of 2 years.	For this evaluation the investigators will use the Quality of life in bronchiectasis (QOLB) (Chalmers, 2014)
Cough Impact Assessment	Through study completion, an average of 2 years.	For this evaluation the investigators will use the Leicester Cough Questionnaire (LCQ), (Murray, 2009).
Health-Related Quality of Life	Through study completion, an average of 2 years.	For this evaluation the investigators will use the Short Form Health Survey (SF-36) (Ware, 1992)
Pulmonary Function Test	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%).

Trial Locations

Locations (1)

Ribeirão Preto Medical School; 🇧🇷 Ribeirão Preto, São Paulo, Brazil