Bronchiectasis
Conditions
Keywords
Bronchiectasis, Mucociliary clearance, Exercise, Inflammation
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
Interventions
OTHERPulmonary 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.
OTHERControl
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
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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). |
| 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%). |
| 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. |
| 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. |
| 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) |
| 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) |
| 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. |
| 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. |
| 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) |
Countries
Brazil
Contacts
Primary ContactAda C Gastaldi, PhD
Outcome results
None listed