Effects of Pilates in Patients With Post- -COVID-19 Syndrome: Controlled and Randomized Clinical Trial

The COVID-19 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 time, called Post-COVID-19 Syndrome, directly interfering with the functional capacity and quality of life of these patients. Pilates exercises focus on breathing, postural symmetry, trunk stabilization, flexibility, joint mobility and strengthening through the full range of motion of all joints and not isolated muscle groups. The objective of this study will be to evaluate the clinical and functional effects of a Pilates for patients post hospitalization for COVID-19. A randomized and controlled clinical trial will be conducted, with recruitment patients who have developed the severe form of COVID-19 and required at least 7 days of invasive mechanical ventilation. They will be previously randomized in a 1:1 ratio by electronic system and blindly allocated to the intervention group that will perform an exercise protocol based on the Pilates method, 2x/week, for 12 weeks in therapeutic sessions of identical protocols lasting 60 min. All patients will be evaluated before and after for six minutes walk distance test, peripheral and respiratory muscle strength and endurance, post-COVID-19 functional status, dyspnea, and quality of life. The analysis will be based on intention-to-treat principles. Descriptive statistics will be used to present the characteristics of participants in the two treatment groups. P values less than 0.05 will be considered to indicate statistical evidence of significance. The variables of dyspnea, peripheral and respiratory muscle strength, functional capacity, post-COVID functional status and HRQoL will be analyzed using linear models of repeated measures which included all values measured after randomization with baseline scores and treatment clusters as covariates. Adjusted mean differences will be tested 12 weeks after randomization and start of intervention. Multiple comparisons will be performed using the Tukey Test with p-values adjusted using the Holm procedure. Baseline variables will be evaluated as predictors and moderators of treatment effects, including terms and interaction models. Effect sizes for primary and secondary endpoints will be calculated as Cohen's d from estimated marginal means (SMD) and standard error estimates from the adjusted primary analysis. All analyzes were performed using RStudio version 0.99.486. Results: The expected results are based on the alternative hypothesis that Pilates exercises are clinically effective, improving functional performance, exercise tolerance, reducing symptoms and improving the quality of life of patients with symptoms of Post-COVID-19 Syndrome.

Inclusion Criteria:Patients previously diagnosed with COVID-19, who required hospitalization and required invasive mechanical ventilation for at least 7 days and who were discharged between August and December 2021 to minimize regression to mean;Both sexes;Over 18 years of age.Exclusion Criteria:Need for supplemental home oxygen;Motor or neurological or cognitive alteration that contraindicates the practice of Pilates.Persistence of clinical signs of deep vein thrombosisUpper limb dynamometry < 14 kgs for men and < 7 kgs for women would indicate very marked peripheral muscle weakness and would therefore contraindicate Pliates at the moment.