Effects of Cardiopulmonary Rehabilitation in Participants With Post-COVID 19 Syndrome.

NCT ID: NCT05402007

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2023-03-23

Brief Summary

COVID-19 is an emerging pandemic disease caused by severe acute respiratory syndrome (SARS-CoV-2). Although the majority of patients infected with SARS-CoV-2 are asymptomatic or have mild symptoms, some patients develop severe symptoms that can protractedly 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 period, called Post-Covid-19 Syndrome, directly interfering with the functional capacity and quality of life of these participants. Cardiopulmonary Rehabilitation exercises are focused on restoring functional capacity in patients affected by cardiopulmonary diseases. The primary objective of this study is to evaluate the clinical and functional effects of a quarterly Cardiopulmonary Rehabilitation exercise program for participants with post-COVID-19 syndrome.

The secondary objectives will be: To compare the effects of a supervised program of 12 weeks of supervised exercises and a program of self-performed home exercises, guided by an exercise booklet, of the same duration on muscle strength and peripheral resistance; Compare the effects of a 12-week supervised exercise program and a self-performed home exercise program, guided by an exercise booklet, of the same duration on levels of fatigue and dyspnea in patients with post-COVID-19 syndrome; Compare the effects of a 12-week supervised exercise program and a self-performed home exercise program, guided by an exercise booklet, of the same duration on health-related quality of life and post-COVID-19 functional status.

Detailed Description

This is a randomized, controlled, double-blind treatment trial with a 1:1 allocation ratio.

Participants: Patients will be recruited at the Central Hospital of the Military Police and in the specialized multidisciplinary follow-up outpatient clinic after COVID-19. The participants will be adults (≥18 years and ≤ 65 years), with a previous diagnosis COVID-19, who required hospitalization and need for invasive mechanical ventilation for at least 7 days and who were discharged from the hospital between August and Dec 2021.

Intervention and comparison:

This study will be divided into three groups: control group, face-to-face intervention group and home intervention group. Both groups will be evaluated before and after the study period, however the control group will only receive the treatment offered to the other groups after the end of the study. Physical functions and functional capacity will be evaluated.

After ensuring that patients meet the inclusion criteria, they will be divided into groups that will receive supervised care in a supervised Pulmonary Rehabilitation Center, with protocoled exercises, the other group will receive a booklet of self-explanatory exercises for performing the exercises in home, and the control group that will not receive intervention in this period.

The intervention groups should perform the exercises in the period of 12 weeks, 2 times a week, totaling 24 intervention sessions.

Conditions

Post- COVID-19 Syndrome; Exercises; Pulmonary Rehabilitation; COVID-19; Randomized Clinical Trial

Study Design

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

Study Groups

Control

The control group will not receive intervention during the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Face-to-face intervention

The face-to-face intervention group will perform pulmonary rehabilitation at the professional-oriented Rehabilitation Center.

Group Type: ACTIVE_COMPARATOR

Pulmonary rehabilitation exercises at the Rehabilitation Center

Intervention Type: OTHER

Face-to-face intervention (12 weeks): Using the participants' assessment and personal characteristics, the therapist will prescribe pulmonary rehabilitation exercises that will be performed at the pulmonary rehabilitation center.

Home intervention

The home intervention group will carry out home intervention through a self-explanatory exercise booklet.

Group Type: ACTIVE_COMPARATOR

Home Intervention

Intervention Type: OTHER

Home Intervention (12 weeks): Using the participants' assessment and personal characteristics, the therapist will provide a portfolio of self-explanatory exercises, and guide participants on safety precautions.

Interventions

Pulmonary rehabilitation exercises at the Rehabilitation Center

Face-to-face intervention (12 weeks): Using the participants' assessment and personal characteristics, the therapist will prescribe pulmonary rehabilitation exercises that will be performed at the pulmonary rehabilitation center.

Intervention Type: OTHER

Home Intervention

Home Intervention (12 weeks): Using the participants' assessment and personal characteristics, the therapist will provide a portfolio of self-explanatory exercises, and guide participants on safety precautions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 old and under 65 years old.

Exclusion Criteria

• Need for supplemental home oxygen;
• Motor or neurological or cognitive alteration that contraindicates the participation in the cardiopulmonary rehabilitation program.
• Persistence of clinical signs of deep vein thrombosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro Universitário Augusto Motta

OTHER

Sponsor Role: lead

Responsible Party

Ana Carolina Sebastião da Silva

Master's Degree

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Carolina Sebastião da Silva

Role: PRINCIPAL_INVESTIGATOR

Centro Universitário Augusto Motta

Locations

Centro de Fisiatria e Reabilitação da Polícia Militar- RJ

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

Other Identifiers

NTC20457

Identifier Type: -

Identifier Source: org_study_id