Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05722730 |
Other study ID # |
NTC12345678 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 9, 2022 |
Est. completion date |
June 30, 2023 |
Study information
Verified date |
February 2023 |
Source |
Centro Universitário Augusto Motta |
Contact |
Michelle de Aguiar Zacaria |
Phone |
+5541984276132 |
Email |
michelle.aguiarz[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.