Introduction: COVID-19 is an emerging pandemic disease caused by severe acute respiratory
syndrome (SARS-CoV-2). Although most patients infected with SARS-CoV-2 are asymptomatic
or have mild symptoms, some patients develop severe symptoms that can long-term 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 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. Objectives: The objective of this study will be to evaluate the
clinical and functional effects of a Pilates exercise program for patients with
Post-Covid-19 syndrome after a period of intensive care admission and invasive mechanical
ventilation. Methods: The study will be a clinical, randomized and controlled trial. 48
patients of both sexes, over 18 years of age, who have developed the severe form of
COVID-19 and required at least 7 days of invasive mechanical ventilation will be
recruited. Patients who currently require supplemental oxygen at home and who present
motor, cognitive or neurological alterations that prevent the practice of Pilates will be
excluded. 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, fatigue and quality of life. The analysis of
the data obtained during the research was carried out by an independent statistician who
had access to the coded data and were based on intention-to-treat principles. Missing
data will be assumed to be completely missing by chance. Multiple imputation was used to
explain these missing data (STERNE et al., 2009). Missing values in the outcome variables
were estimated using multiple imputation by chained equations after 50 imputed replicated
data sets. Variables included in the multiple imputation process included (1) group
factor, (2) time factor, and (3) the respective outcome variable. 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 fatigue, peripheral muscle strength, functional capacity,
post-COVID functional status and HRQoL were analyzed using linear models of repeated
measures (participants and time as random factors) 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 were performed using the Tukey Test with p-values adjusted using the
Holm procedure. Baseline variables were evaluated as predictors and moderators of
treatment effects, including terms and interaction models. Effect sizes for primary and
secondary endpoints were calculated as Cohen's d from estimated marginal means (SMD) and
standard error estimates from the adjusted primary analysis. Effect sizes were
interpreted according to Cohen's criteria (small ≤0.2; moderate=0.5; large ≥0.8)(COHEN,
1988). 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.