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Clinical Trials/NCT04913129
NCT04913129
Completed
N/A

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

Mayo Clinic1 site in 1 country27 target enrollmentNovember 4, 2021
ConditionsCovid19

Overview

Phase
N/A
Intervention
Not specified
Conditions
Covid19
Sponsor
Mayo Clinic
Enrollment
27
Locations
1
Primary Endpoint
Maximal oxygen update (VO2max) measured in mL/kg/min
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 4, 2021
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bryan Taylor

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Right ventricular contractile function measured as % fractional area change (RV FAC)(8 weeks)
  • Forced vital capacity (FVC) measured in L(8 weeks)
  • Forced expiratory volume in 1 second (FEV1) measured in L(8 weeks)
  • Maximal inspiratory pressure (MIP) measured in cmH2O(8 weeks)
  • Peak exercise work rate (Wpeak) measured in Watts(8 weeks)
  • Left ventricular contractile function measured as % fractional area change (LV FAC)(8 weeks)
  • Maximal expiratory pressure (MEP) measured in cmH2O(8 weeks)

Study Sites (1)

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