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

NCT05722730 | Unknown

• 1 other identifier: NTC12345678
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; Pilates Method; Functional Status; Health-related quality of life; Dyspnea

Outcome Measures

Primary Outcomes (2)

• Functional Capacity

  Functional capacity will be measured by the distance covered in the 6-minute walk test. The distance covered will be expressed in meters and compared in absolute and relative values to predict normality for the studied population.

  12 weeks

• Functional Status

  Functional status will be measured by the Post-COVID-19 Functional Status scale,which is graded from 0 to 4, with the highest score being the worst.

  12 weeks

Secondary Outcomes (5)

• Peripheral muscle endurance

  12 weeks

• Respiratory muscle strength

  12 weeks

• Peripheral muscle strength

  12 weeks

• Dyspnea

  12 weeks

• Health-related quality of life

  12 weeks

Study Arms (2)

Pilates

EXPERIMENTAL

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.

Procedure: Pilates Exercises

Control

NO INTERVENTION

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

Interventions

Pilates Exercises 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.

Also known as: Therapeutic Pilates

Pilates

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Need for supplemental home oxygen;
• Motor or neurological or cognitive alteration that contraindicates the practice of Pilates.
• Persistence of clinical signs of deep vein thrombosis
• 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.

Sponsors & Collaborators

• Michele de Aguiar Zacaria: lead

Study Sites (1)

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

Rio de Janeiro, 21073-460, Brazil

RECRUITING

MeSH Terms

Conditions

COVID-19; Dyspnea

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Officials

• Michelle de Aguiar Zacaria

  Centro Universitário Augusto Motta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle de Aguiar Zacaria

CONTACT

+5541984276132; michelle.aguiarz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Initial assessments and assessments relating to clinical evolution will be conducted by an assessor blinded to treatment allocation. The evaluator will undergo an in-depth evaluation training program. An employee outside the research team will feed the computer database into secretly coded spreadsheets so that the independent statistician and researchers can analyze the data without having access to allocation information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Clinical Trial involving participants, 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, 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.

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: February 10, 2023
• Study Start: May 9, 2022
• Primary Completion: March 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

BR (1)