Back to resultsThe Burden of COVID-19 Survivorship
Primary Purpose
Covid19
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Training
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
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.
Sites / Locations
- Mayo Clinic in FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Interventional (exercise training) Group
Arm Description
Standard physician-guided medical care after COVID-19
8 week home-based exercise training
Outcomes
Primary Outcome Measures
Maximal oxygen update (VO2max) measured in mL/kg/min
VO2max is the maximal oxygen consumed during an exhaustive exercise test
Secondary Outcome Measures
Peak exercise work rate (Wpeak) measured in Watts
Wpeak is the highest achieved power during a maximal incremental cycle exercise test
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
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
Maximal inspiratory pressure (MIP) measured in cmH2O
Highest inspiratory muscle pressure (i.e. inspiratory muscle strength) during a maximal inspiratory effort
Maximal expiratory pressure (MEP) measured in cmH2O
Highest expiratory muscle pressure (i.e. expiratory muscle strength) during a maximal expiratory effort
Left ventricular contractile function measured as % fractional area change (LV FAC)
LV FAC is a measure of overall contractile function of the LV
Right ventricular contractile function measured as % fractional area change (RV FAC)
RV FAC is a measure of overall contractile function of the RV
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04913129
Brief Title
The Burden of COVID-19 Survivorship
Official Title
The Burden of COVID-19 Survivorship: Exercise Therapy to Combat the Sequelae of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standard physician-guided medical care after COVID-19
Arm Title
Interventional (exercise training) Group
Arm Type
Experimental
Arm Description
8 week home-based exercise training
Intervention Type
Other
Intervention Name(s)
Exercise Training
Intervention Description
8 week home-based exercise therapy 4-5 times/week
Primary Outcome Measure Information:
Title
Maximal oxygen update (VO2max) measured in mL/kg/min
Description
VO2max is the maximal oxygen consumed during an exhaustive exercise test
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Peak exercise work rate (Wpeak) measured in Watts
Description
Wpeak is the highest achieved power during a maximal incremental cycle exercise test
Time Frame
8 weeks
Title
Forced vital capacity (FVC) measured in L
Description
FVC is the largest amount of air that can be exhaled from the lungs in one maximal breath
Time Frame
8 weeks
Title
Forced expiratory volume in 1 second (FEV1) measured in L
Description
FEV1 is the largest amount of air that can be exhaled from the lungs in the first second of one maximal breath
Time Frame
8 weeks
Title
Maximal inspiratory pressure (MIP) measured in cmH2O
Description
Highest inspiratory muscle pressure (i.e. inspiratory muscle strength) during a maximal inspiratory effort
Time Frame
8 weeks
Title
Maximal expiratory pressure (MEP) measured in cmH2O
Description
Highest expiratory muscle pressure (i.e. expiratory muscle strength) during a maximal expiratory effort
Time Frame
8 weeks
Title
Left ventricular contractile function measured as % fractional area change (LV FAC)
Description
LV FAC is a measure of overall contractile function of the LV
Time Frame
8 weeks
Title
Right ventricular contractile function measured as % fractional area change (RV FAC)
Description
RV FAC is a measure of overall contractile function of the RV
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Taylor, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chary Aleger
Phone
904-953-4603
Email
Aleger.chary@mayo.edu
First Name & Middle Initial & Last Name & Degree
Bryan J Taylor, PhD
Phone
9049537274
Email
taylor.bryan@mayo.edu
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
The Burden of COVID-19 Survivorship
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