Pulmonary Rehabilitation in Non-Cystic Fibrosis Bronchiectasis

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Bronchiectasis

Intervention / Treatment
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* Other: Pulmonary Rehabilitation
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bronchiectasis Pulmonary Rehabilitation<br>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<br>* 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.<br>|
| Experimental: Healthy Pulmonary Rehabilitation<br>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<br>* 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.<br>|
| Sham Comparator: Bronchiectasis Group Control<br>The volunteers with bronchiectasis will be informed only about the benefits of physical activities | Other: Control<br>* 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<br>|
| Sham Comparator: Healthy Group Control<br>Volunteers healthy will be informed only about the benefits of physical activities | Other: Control<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucociliary transport in vivo | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | It will be collected as previously described (Koczulla et al., 2009). | Through study completion, an average of 2 years | 
| Exhaled Nitric Oxide Fraction (FeNO) | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiectasis, Mucociliary clearance, Exercise, Inflammation