The Burden of COVID-19 Survivorship

Not Applicable

Recruiting

• Conditions: Covid19
• Interventions: Other: Exercise Training

• Registration Number: NCT04913129
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-05-31
• Study First Submitted QC: 2021-05-31
• Study First Posted: 2021-06-04
• Study Start: 2021-11-04
• Primary Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional (exercise training) Group	Exercise Training	8 week home-based exercise training

Primary Outcome Measures

Name	Time	Method
Maximal oxygen update (VO2max) measured in mL/kg/min	8 weeks	VO2max is the maximal oxygen consumed during an exhaustive exercise test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States