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NCT Number: NCT04913129

The Burden of COVID-19 Survivorship

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise training

Other

8 week home-based exercise therapy 4-5 times/week

Primary outcomes

  1. Maximal oxygen update (VO2max) measured in mL/kg/min

    Time frame: 8 weeks

    VO2max is the maximal oxygen consumed during an exhaustive exercise test

Secondary outcomes

  1. Peak exercise work rate (Wpeak) measured in Watts

    Time frame: 8 weeks

    Wpeak is the highest achieved power during a maximal incremental cycle exercise test

  2. Forced vital capacity (FVC) measured in L

    Time frame: 8 weeks

    FVC is the largest amount of air that can be exhaled from the lungs in one maximal breath

  3. Forced expiratory volume in 1 second (FEV1) measured in L

    Time frame: 8 weeks

    FEV1 is the largest amount of air that can be exhaled from the lungs in the first second of one maximal breath

  4. Maximal inspiratory pressure (MIP) measured in cmH2O

    Time frame: 8 weeks

    Highest inspiratory muscle pressure (i.e. inspiratory muscle strength) during a maximal inspiratory effort

  5. Maximal expiratory pressure (MEP) measured in cmH2O

    Time frame: 8 weeks

    Highest expiratory muscle pressure (i.e. expiratory muscle strength) during a maximal expiratory effort

  6. Left ventricular contractile function measured as % fractional area change (LV FAC)

    Time frame: 8 weeks

    LV FAC is a measure of overall contractile function of the LV

  7. Right ventricular contractile function measured as % fractional area change (RV FAC)

    Time frame: 8 weeks

    RV FAC is a measure of overall contractile function of the RV

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jun 4, 2021
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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