The Burden of COVID-19 Survivorship

Study Overview
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Brief Summary
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This research study is being done to find out what the longer-term physiological consequences of COVID-19 are, and to determine if exercise therapy can help improve lung function, heart function and overall fitness, and reduce symptoms in people recovering from SARS-CoV-2.

Detailed Description
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The purpose of this research is to see if taking part in structured exercise training will improve the ability to exercise, the function of the lungs and the function of the heart, and reduce symptoms of fatigue and breathlessness in people recovering from COVID-19. After enrollment all patients will complete exercise testing, lung function testing, and cardiac imaging. Patients will be randomized to either 8 weeks of exercise training (4-5 times per week) or will continue standard medical care. All patients will undergo detailed exercise testing, lung function testing, and cardiac imaging after the intervention.

Official Title
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The Burden of COVID-19 Survivorship: Exercise Therapy to Combat the Sequelae of COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Other: Exercise Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 21 to 75 years. History of RT-PCR proven SARS-CoV-2 infection. Deemed 'recovered' from SARS-CoV-2 infection. Not clinically obese (BMI ≥ 36) and/or suffer from musculoskeletal or other conditions that would limit exercise participation. No evidence of cardiac ischemia at rest or during exertion (via ECG). Able to provide written informed consent. Exclusion Criteria: Individuals less than 21 or more than 75 years old. Not able to take part in structured exercise training due to injury or other conditions that would put person at risk during exercise. Unable to provide written informed consent.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Standard physician-guided medical care after COVID-19 | |
| Experimental: Interventional (exercise training) Group<br>8 week home-based exercise training | Other: Exercise Training<br>* 8 week home-based exercise therapy 4-5 times/week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal oxygen update (VO2max) measured in mL/kg/min | VO2max is the maximal oxygen consumed during an exhaustive exercise test | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak exercise work rate (Wpeak) measured in Watts | Wpeak is the highest achieved power during a maximal incremental cycle exercise test | 8 weeks | 
| Forced vital capacity (FVC) measured in L | FVC is the largest amount of air that can be exhaled from the lungs in one maximal breath | 8 weeks | 
| Forced expiratory volume in 1 second (FEV1) measured in L | FEV1 is the largest amount of air that can be exhaled from the lungs in the first second of one maximal breath | 8 weeks | 
| Maximal inspiratory pressure (MIP) measured in cmH2O | Highest inspiratory muscle pressure (i.e. inspiratory muscle strength) during a maximal inspiratory effort | 8 weeks | 
| Maximal expiratory pressure (MEP) measured in cmH2O | Highest expiratory muscle pressure (i.e. expiratory muscle strength) during a maximal expiratory effort | 8 weeks | 
| Left ventricular contractile function measured as % fractional area change (LV FAC) | LV FAC is a measure of overall contractile function of the LV | 8 weeks | 
| Right ventricular contractile function measured as % fractional area change (RV FAC) | RV FAC is a measure of overall contractile function of the RV | 8 weeks |