The Burden of COVID-19 Survivorship

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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Other: Exercise Training

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic in Florida
      • Contact: Chary Aleger; Phone Number: 904-953-4603; Email: Aleger.chary@mayo.edu
      • Contact: Bryan J Taylor, PhD; Phone Number: 9049537274; Email: taylor.bryan@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Bryan Taylor, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 21-002693

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No