Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05722730
Status:
RECRUITING
Last Update Posted:
2023-02-10
First Post:
2022-10-24
Brief Title:
Effects of Pilates in Patients With Post- -COVID-19 Syndrome Controlled and Randomized Clinical Trial
Sponsor:
Michele de Aguiar Zacaria
Organization:
Centro Universitário Augusto Motta
Study Overview
Official Title:
Effects of Pilates in Patients With Post- -COVID-19 Syndrome Controlled and Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 ratio by electronic system and blindly allocated to the intervention group that will perform an exercise protocol based on the Pilates method 2xweek 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 005 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 Cohens d from estimated marginal means SMD and standard error estimates from the adjusted primary analysis All analyzes were performed using RStudio version 099486 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
Detailed 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 11 ratio by electronic system and blindly allocated to the intervention group that will perform an exercise protocol based on the Pilates method 2xweek 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 005 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 Cohens d from estimated marginal means SMD and standard error estimates from the adjusted primary analysis Effect sizes were interpreted according to Cohens criteria small 02 moderate05 large 08COHEN 1988 All analyzes were performed using RStudio version 099486 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None