Pulmonary Rehabilitation in Non-Cystic Fibrosis Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02823587
• Other study ID #: USP 2016-1
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2016
• Last updated: August 16, 2017
• Start date: July 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2016
• Source: University of Sao Paulo
• Contact: Ada C Gastaldi, PhD
• Phone: 55 16 33150473
• Email: ada[@]fmrp.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

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.
• 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

Locations

Country	Name	City	State
Brazil	Ribeirão Preto Medical School	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View 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;10:78. doi: 10.1186/1465-9921-10-78. — View 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. — View 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. — View Citation

Trindade SH, de Mello JF Jr, Mion Ode G, Lorenzi-Filho G, Macchione M, Guimarães ET, Saldiva PH. Methods for studying mucociliary transport. Braz J Otorhinolaryngol. 2007 Sep-Oct;73(5):704-12. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Exhaled breath condensate	It will be collected as previously described (Koczulla et al., 2009).	Through study completion, an average of 2 years
Secondary	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
Secondary	Cytokine Analysis TNF-a	The tumor necrosis factor-alpha concentrations (TNF-a) 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
Secondary	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
Secondary	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