The Burden of COVID-19 Survivorship

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04913129
• Other study ID #: 21-002693
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• Exercise Training
8 week home-based exercise therapy 4-5 times/week

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal oxygen update (VO2max) measured in mL/kg/min	VO2max is the maximal oxygen consumed during an exhaustive exercise test	8 weeks
Secondary	Peak exercise work rate (Wpeak) measured in Watts	Wpeak is the highest achieved power during a maximal incremental cycle exercise test	8 weeks
Secondary	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
Secondary	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
Secondary	Maximal inspiratory pressure (MIP) measured in cmH2O	Highest inspiratory muscle pressure (i.e. inspiratory muscle strength) during a maximal inspiratory effort	8 weeks
Secondary	Maximal expiratory pressure (MEP) measured in cmH2O	Highest expiratory muscle pressure (i.e. expiratory muscle strength) during a maximal expiratory effort	8 weeks
Secondary	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
Secondary	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