Pulmonary Rehabilitation Associated with Noninvasive Ventilation on Physical Capacity and Quality of Life in Post-COVID-19: A Randomized Controlled Double-Blinded Clinical Trial Protocol

Abstract

Guilherme Peixoto Tinoco Arêas,1,2 Cássia da Luz Goulart,3 Thaís Sant’Anna,4 Tiótrefis Gomes Fernandes,4 Rafael de Oliveira Alvim,1 Fernanda Facioli dos Reis Borges,1 Camila Miriam Suemi Sato Barros do Amaral,3 Suzy Cristina França Rodrigues,1 Jefferson Valente,3 João Marcos Bemfica Barbosa Ferreira,5 Anna Gabriela Rezende,1,3 Edival Ferreira de Oliveira Júnior,6 Marcus Vinícius Guimarães de Lacerda,3,7,8 Fernando Fonseca de Almeida-Val1– 4 1Department of Physiological Sciences, Exercise Physiology Laboratory, Federal University of Amazonas, Manaus, AM, Brasil; 2Cardiopulmonary Laboratory, Getúlio Vargas University Hospital, UFAM, Manaus, AM, Brasil; 3Dr Heitor Vieira Dourado Tropical Medicine Foundation, Manaus, AM, Brasil; 4Faculty of Physical Education and Physiotherapy, Respiratory and Cardiovascular Physiotherapy Laboratory, Federal University of Amazonas, Manaus, AM, Brasil; 5Higher School of Health Sciences, Faculty of Medicine, State University of Amazonas, Manaus, AM, Brasil; 6Francisca Mendes University Hospital, Manaus, AM, Brasil; 7Leônidas and Maria Deane Institute, Fiocruz Amazonas, Manaus, AM, Brasil; 8University of Texas Medical Branch at Galveston, Galveston, TX, USACorrespondence: Guilherme Peixoto Tinoco Arêas, Departamento de Ciências Fisiológicas, Universidade Federal Do Amazonas, Avenida Rodrigo Otávio, 6200, Manaus, AM, 69080-900, Brasil, Email [email protected]: The coronavirus disease-2019 (COVID-19) pulmonary rehabilitation (PR) seems to be a better choice to improve physical and functional capacity after acute infection. However, there is a lack of evidence regarding the effects of different strategies to optimize post-acute phase rehabilitation and reduce long COVID-19 physical deteriorations.Objective: To compare the use of a noninvasive ventilation (NIV) plus aerobic exercise strategy during PR program with to a standard PR (without NIV) on physical capacity and quality of life outcomes in post-COVID-19.Methods: Double-blinded randomized controlled clinical trial. A total of 100 individuals discharged from hospital in a post-acute phase of severe COVID-19 will be randomized into two groups: PR + NIV (Group 1) and PR (Group 2). Inclusion criteria include participants who present symptomatic dyspnea II and III by the modified Medical Research Council, aged 18 years or older. Both groups will receive aerobic and resistance exercise, and inspiratory muscle training. However, group 1 will perform aerobic training with bilevel NIV. Cardiopulmonary exercise test will assess the O2 peak uptake, 6-minute walk test will assess the walking distance and short-form 36 will assess the quality of life before and after 8 weeks (after 24 PR sessions). Moreover, patients will be contacted by telephone every 3 months for one year to record possible adverse events, hospitalizations, and death. All data will be registered in RedCap, and analyses will be performed in the STATA v13 software.Clinical Trial Registration: RBR-3t9pkzt.Keywords: COVID-19, noninvasive ventilation, pulmonary rehabilitation

Keywords

• covid-19
• noninvasive ventilation
• pulmonary rehabilitation