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

NCT ID: NCT05722730

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2023-06-30

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 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.

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 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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pilates

The Pilates exercise protocol was designed based on protocols contained in previously published clinical trials whose objective had been muscle strengthening or improvement of muscle fatigue. Thus, the protocol will perform exercises from the classic repertoire of the Pilates Method, using equipment exclusive to the Method - such as Cadillac, Lader Barrel, Chair and Reformer. The sessions will take place twice a week, in a group of up to 3 participants, always in the morning lasting 60 minutes, with 10 minutes of warm-up, 40 minutes of load exercises and 10 minutes of relaxation exercises and calm down. All sessions were carried out by a physiotherapist specialized in the method, in a specific outpatient clinic. The professional who conducted the Pilates sessions, performed the proposed protocol, is unaware of the outcomes studied by the project.

Group Type: EXPERIMENTAL

Pilates Exercises

Intervention Type: PROCEDURE

The intervention group will perform an exercise protocol based on the Pilates method, by a physiotherapist specialized in Pilates and independent of the researchers, using the method's own equipment, with a frequency of 2x/week, for 12 weeks in therapeutic sessions of identical protocols lasting 60 min.

Control

Only follow-up of the clinical evolution will be carried out

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pilates Exercises

The intervention group will perform an exercise protocol based on the Pilates method, by a physiotherapist specialized in Pilates and independent of the researchers, using the method's own equipment, with a frequency of 2x/week, for 12 weeks in therapeutic sessions of identical protocols lasting 60 min.

Intervention Type: PROCEDURE

Other Intervention Names

Therapeutic Pilates

Eligibility Criteria

Inclusion Criteria

1. 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;

2. Both sexes;

3. Over 18 years of age.

Exclusion Criteria

1. Need for supplemental home oxygen;

2. Motor or neurological or cognitive alteration that contraindicates the practice of Pilates.

3. Persistence of clinical signs of deep vein thrombosis

4. Upper 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michele de Aguiar Zacaria

OTHER

Sponsor Role: lead

Responsible Party

Michele de Aguiar Zacaria

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michelle de Aguiar Zacaria

Role: PRINCIPAL_INVESTIGATOR

Centro Universitário Augusto Motta

Locations

Centro de Fisiatria e Reabilitação da Polícia Militar do Estado do Rio de Janeiro

Rio de Janeiro, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Michelle de Aguiar Zacaria

Role: CONTACT

michelle.aguiarz@gmail.com

+5541984276132

Facility Contacts

Luis Felipe da Fonseca Reis, Prof. ou Ten Cel PM Fisio

Role: primary

luisfelipefreis@gmail.com

(21) 2290-1462

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

NTC12345678

Identifier Type: -

Identifier Source: org_study_id