Marcela Maria Carvalho da Silva1, Juliano Ferreira Arcuri2, Valéria Amorim Pires Di Lorenzo2. 1. Postgraduate Physiotherapy Department of Federal University of São Carlos, Rodovia Washington Luiz, São Carlos, São Paulo, 13565-905, Brazil. marcelacarvalhofisioterapia@yahoo.com.br. 2. Postgraduate Physiotherapy Department of Federal University of São Carlos, Rodovia Washington Luiz, São Carlos, São Paulo, 13565-905, Brazil.
Abstract
BACKGROUND:Patients with chronic obstructive pulmonary disease (COPD) present pulmonary and extrapulmonary impairments. The strategies used to mitigate these impairments are pulmonary rehabilitation programs (PRP). However, there is limited access to PRP in specialized centers and the study of low-cost home rehabilitation programs had non-individualized prescription, which might have led to insignificant positive effects. So, it is important to develop new low-cost protocols that involve individualized prescription, as well as physiotherapist supervision. This study describes an accessible, low-cost, and individualized pulmonary rehabilitation protocol and compare its results when performed with or without a weekly physiotherapist-supervised session on patients with COPD. METHODS: This is a descriptive protocol of a clinical trial, randomized, single-blinded, and type of framework is superiority conducted at the Spirometry and Respiratory Physical Therapy Laboratory of the Federal University of São Carlos (UFSCar). The trial is registered in the Brazilian Clinical Trials Registry (ReBec) URL: http://www.ensaiosclinicos.gov.br/rg/RBR-533hht/ with Register Number UTN code U1111-1220-8245. The sample size is 50 patients and is calculated using the results of a pilot study. DISCUSSION-POTENTIAL IMPACT AND SIGNIFICANCE OF THE STUDY: It is expected that the low-cost and new supervised rehabilitation program complemented with home exercises will present positive results, especially on exercise capacity, which will make available a more accessible and effective PRP for patients with COPD. TRIAL REGISTRATION: ClinicalTrials.gov U1111-1220-8245 . Registered on September 20, 2018.
RCT Entities:
BACKGROUND:Patients with chronic obstructive pulmonary disease (COPD) present pulmonary and extrapulmonary impairments. The strategies used to mitigate these impairments are pulmonary rehabilitation programs (PRP). However, there is limited access to PRP in specialized centers and the study of low-cost home rehabilitation programs had non-individualized prescription, which might have led to insignificant positive effects. So, it is important to develop new low-cost protocols that involve individualized prescription, as well as physiotherapist supervision. This study describes an accessible, low-cost, and individualized pulmonary rehabilitation protocol and compare its results when performed with or without a weekly physiotherapist-supervised session on patients with COPD. METHODS: This is a descriptive protocol of a clinical trial, randomized, single-blinded, and type of framework is superiority conducted at the Spirometry and Respiratory Physical Therapy Laboratory of the Federal University of São Carlos (UFSCar). The trial is registered in the Brazilian Clinical Trials Registry (ReBec) URL: http://www.ensaiosclinicos.gov.br/rg/RBR-533hht/ with Register Number UTN code U1111-1220-8245. The sample size is 50 patients and is calculated using the results of a pilot study. DISCUSSION-POTENTIAL IMPACT AND SIGNIFICANCE OF THE STUDY: It is expected that the low-cost and new supervised rehabilitation program complemented with home exercises will present positive results, especially on exercise capacity, which will make available a more accessible and effective PRP for patients with COPD. TRIAL REGISTRATION: ClinicalTrials.gov U1111-1220-8245 . Registered on September 20, 2018.
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