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

NCT05402007 | Completed

• 1 other identifier: NTC20457
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

COVID-19; Post- COVID-19 syndrome; Pulmonary Rehabilitation; Exercises

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Quality of life improvement

  12 weeks

Study Arms (3)

Control

NO INTERVENTION

The control group will not receive intervention during the study.

Face-to-face intervention

ACTIVE COMPARATOR

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

Other: Pulmonary rehabilitation exercises at the Rehabilitation Center

Home intervention

ACTIVE COMPARATOR

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

Other: Home Intervention

Interventions

Pulmonary rehabilitation exercises at the Rehabilitation Center 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.

Face-to-face intervention

Home Intervention 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.

Home intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 old and under 65 years old.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead

Study Sites (1)

Centro de Fisiatria e Reabilitação da Polícia Militar- RJ

Rio de Janeiro, Rio de Janeiro, 21073-460, Brazil

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Motor Activity; COVID-19

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; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Ana Carolina Sebastião da Silva

  Centro Universitário Augusto Motta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The study will be a clinical trial previously randomized by electronic randomization system (www.random.org) and the allocation of volunteers in the study arms will be done without the participation of the researchers. The study will be double-blind since neither the volunteers nor the professional who will perform the Cardiopulmonary Rehabilitation protocol is aware of the objectives and clinical valences that will be measured by the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Degree

Model Details: Three pre-post assessment groups (control/face-to-face intervention/self-performed home intervention)

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: June 2, 2022
• Study Start: June 30, 2022
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)