COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE): A Randomized Controlled Trial

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The emergence of SARS-CoV-2 as a novel coronavirus at the end of 2019 (COVID-19) resulted in a pandemic that has affected millions of people worldwide. While clinicians and scientists have gained a better understanding of the various presentations and manifestations of the initial COVID-19 infection, attention has now turned to the recovery trajectory and long-term sequelae of COVID-19. Many hospitalized people require follow-up care related to critical illness and prolonged hospitalization, however there remains a rehabilitation need even among those that were never hospitalized and/or initially presented with milder symptoms of COVID-19. Referred to commonly as long-haulers or long-COVID, it is estimated that 23% of those recovered from COVID-19 will experience Post-Acute Sequelae of COVID-19 (PASC), that is persistent symptoms affecting daily functioning and quality of life. Fatigue, dyspnea, chest pain/tightness have been reported as common persistent physical symptoms, as well as psychological symptoms such as anxiety/depression and cognitive complaints. Effective use of aerobic exercise training as a cardiorespiratory, rehabilitative intervention could have a high degree of impact on patient functional and quality of life outcomes. The overall aim of this randomized controlled trial is to determine whether AET is beneficial for improving functional outcomes and recovery among survivors of COVID-19. All participants will perform baseline assessments including physical, cognitive testing, patient-reported outcomes, and vascular function. Thereafter, participants will be randomized to either one of 2 arms for 10 weeks: 1) an aerobic exercise training with education (AET+) group, or 2) a wait-list control group (CON) provided with education only. After 10 weeks, both groups will repeat the same assessments as performed at baseline (10-week follow-up). Following this visit, participants in the CON group will crossover and perform 10 weeks of AET either on-site or remotely, followed by a third assessment visit (20-week follow-up). Participants will also begin wearing a wristwatch accelerometer at the baseline study visit and through to the follow-up time point (10 weeks for AET+, 20 weeks for CON), for continuous collection of free-living physical activity and sleep quality. In addition, all participants will be monitored periodically over one year to capture physical activity, sleep quality and health-related QOL outcomes over time. Recruitment will occur during the phase of long-term recovery and when participants are no longer infectious. The primary outcome measure is distance walked during a 6-minute walk test, and secondary outcome variables include patient-reported outcomes, free-living physical activity and sleep quality. The exploratory outcomes include measures of cardiorespiratory capacity during a maximal exercise test (such as pulmonary gas exchange), vascular function, clinical outcomes, cognition, blood biomarkers, metabolomics, and ultrasound-based muscle measurements. We are collaborating with various NIH institutes to capitalize on their expertise/resources for a multi-systems approach. The use of a crossover control group in the study design will allow examination of the spontaneous recovery for physical function, quality of life outcomes, free-living physical activity and sleep quality among survivors of COVID-19. Total Number of Subjects Enrolled = 41 Total Number of Subjects Enrolled in the current year = 8 Total Number of Subjects Enrolled that are screen failures = 4 Total Number of Subjects Enrolled that withdrew = 5 The current study aims to examine the feasibility of AET for improving outcomes in survivors of COVID-19 that report persistent fatigue and/or physical dysfunction affecting their daily lives. The effective use of aerobic exercise as a rehabilitative intervention could have a high degree of impact on personal and public health outcomes for COVID-19 survivors. By the end of FY23, 11 subjects had completed on-site study procedures and were in the 1-year follow-up period. Twenty subjects had fully completed participation in the study. There were no serious adverse events to report. The study is in the collection phase and we are actively recruiting and enrolling participants.