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

Clinical and Functional Effects of Supervised and Unsupervised Cardiopulmonary Rehabilitation in POST-COVID-19 Syndrome: Clinical and Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Pulmonary Rehabilitation; Randomized Clinical Trial; Post- COVID-19 Syndrome; Exercises
• Intervention / Treatment: Other: Pulmonary rehabilitation exercises at the Rehabilitation Center; Other: Home Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Carolina Sebastião da Silva; Phone Number: +5521970084169; Email: carol.marques_125@hotmail.com

Study Locations

• Brazil
  • RJ
    • Rio De Janeiro, RJ, Brazil, 21073-460
      • Centro de Fisiatria e Reabilitação da Polícia Militar- RJ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control group will not receive intervention during the study.
Active Comparator: Face-to-face intervention; The face-to-face intervention group will perform pulmonary rehabilitation at the professional-oriented Rehabilitation Center.	Other: 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.
Active Comparator: Home intervention; The home intervention group will carry out home intervention through a self-explanatory exercise booklet.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral muscle function I	Will be assessed using the Palm Grip Dynamometry	12 weeks
Peripheral muscle function II	Will be assessed using the Quadriceps Peak Load Test	12 weeks
Peripheral muscle function III	Will be assessed using the Quadriceps Muscle Endurance Test.	12 weeks
Daily living activity	It will be evaluated by the modified Medical Resource Council (mMRC) dyspnea scale	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life improvement	The assessment of quality of life will be carried out using a generic instrument of 36 items, validated in Brazil and called the SF-36 (Short Form Health Survey).	12 weeks

Collaborators and Investigators

• Sponsor: Centro Universitário Augusto Motta
• Investigators: Principal Investigator: Ana Carolina Sebastião da Silva, Centro Universitário Augusto Motta

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): March 23, 2023

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Pulmonary Rehabilitation; Exercises; Post- COVID-19 syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; COVID-19; Syndrome
• Other Study ID Numbers: NTC20457

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No