Clinical trial NCT02823587: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchiectasis
Keywords: Bronchiectasis
Mucociliary clearance
Exercise
Inflammation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Mucociliary transport in vivo
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
measure: Mucociliary transport in vitro
timeFrame: Through study completion, an average of 2 years.
measure: Quality of Life in Bronchiectasis
timeFrame: Through study completion, an average of 2 years.
measure: Cough Impact Assessment
timeFrame: Through study completion, an average of 2 years.
measure: Health-Related Quality of Life
timeFrame: Through study completion, an average of 2 years.
measure: Impulse Oscillometry System (IOS)
timeFrame: Through study completion, an average of 2 years.
measure: Pulmonary Function Test
timeFrame: Through study completion, an average of 2 years.
measure: Six Minute Walking Test
timeFrame: Through study completion, an average of 2 years.
measure: Maximal Static Respiratory Pressures
timeFrame: Through study completion, an average of 2 years.
measure: Viscosity
timeFrame: Through study completion, an average of 2 years.
measure: Elasticity
timeFrame: Through study completion, an average of 2 years.
measure: Exhaled breath condensate
timeFrame: Through study completion, an average of 2 years
measure: Exhaled Nitric Oxide Fraction (FeNO)
timeFrame: Through study completion, an average of 2 years
measure: Cytokine Analysis TNF-α
timeFrame: Through study completion, an average of 2 years
measure: Cytokine Analysis IL-6
timeFrame: Through study completion, an average of 2 years
measure: Cytokine Analysis IL-10
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Ribeirão Preto Medical School
state: São Paulo
Study officials:
affiliation: Ribeirão Preto Medicine School - University of São Paulo
name: Ada C Gastaldi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.