Clinical and functional effects of supervised and unsupervised cardiopulmonary rehabilitation in post-COVID-19 syndrome: a randomized clinical trial

Abstract

Introduction: COVID-19 is an emerging pandemic disease caused by severe acute respiratory syndrome (SARS-CoV-2). Although the majority of patients infected with SARS-CoV-2 are asymptomatic or have mild symptoms, some patients develop severe symptoms that can protractedly impair their quality of life and functional capacity. SARS-CoV-2 is closely related to severe acute respiratory syndrome (SARS) with direct and indirect effects on several systems, especially the musculoskeletal system, in addition to the respiratory system. Some of these symptoms persist for a long period, called post-COVID-19 syndrome (PCS), directly interfering with the functional capacity and quality of life of these participants. Cardiopulmonary Rehabilitation exercises are focused on restoring functional capacity in patients affected by cardiopulmonary diseases. Objectives: The objective of the work is to evaluate the clinical and functional effects of a quarterly Cardiopulmonary Rehabilitation exercise program for participants with PCS. Methods: The study is a clinical, randomized and controlled trial. Ninety participants of both sexes, aged between 18 and 65 years, who developed the severe form of COVID-19 and required at least 7 days of invasive mechanical ventilation, were recruited. Participants who currently need supplemental oxygen at home and who have motor, cognitive or neurological alterations that prevent participation in the Cardiopulmonary Rehabilitation Program were excluded. They were previously randomized in a 1:1 ratio by electronic system and blind allocation to the intervention group that underwent an exercise protocol based on the cardiopulmonary rehabilitation protocol, 2x/week, for 12 weeks in therapeutic sessions of identical protocols lasting 80 to 90 min. All participants were assessed before and after for peripheral muscle strength and endurance, post-COVID functional status, dyspnea,
fatigue, and quality of life. Data analysis will be performed using the SPSS 23.0 program (Statistical Package for Social Sciences). Descriptive analysis will be performed for all variables (mean and standard deviation). General Linear Model (GLMs) with mixed design will be performed to compare the treatment effect size between groups. Pairwise comparisons will be performed to verify the mean difference between the intervention and control groups in all variables in each period independently. Intention-to-treat analysis was used using the Last Observation Carried Forward (LOCF) method for data from missing participants. A significance
level of 0.05 and a confidence interval of 95% will be adopted. Results: The expected results are based on the alternative hypothesis that the cardiopulmonary rehabilitation protocol is clinically effective, improving functional performance, exercise tolerance, reducing symptoms and improving the quality of life of participants with PCS.