Covid19NCT04913129
The Burden of COVID-19 Survivorship
A study testing Exercise Training in people with Covid19, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Covid19
- What is being tested?
- Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Exercise Training
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
8 week home-based exercise therapy 4-5 times/week
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Standard physician-guided medical care after COVID-19 |
| Interventional (exercise training) Group | Experimental | 8 week home-based exercise training Receives: Other: Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen update (VO2max) measured in mL/kg/min
VO2max is the maximal oxygen consumed during an exhaustive exercise test
Measured: 8 weeks
Secondary outcomes (7)
Peak exercise work rate (Wpeak) measured in Watts
Wpeak is the highest achieved power during a maximal incremental cycle exercise test
Measured: 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
Measured: 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
Measured: 8 weeks
Maximal inspiratory pressure (MIP) measured in cmH2O
Highest inspiratory muscle pressure (i.e. inspiratory muscle strength) during a maximal inspiratory effort
Measured: 8 weeks
Maximal expiratory pressure (MEP) measured in cmH2O
Highest expiratory muscle pressure (i.e. expiratory muscle strength) during a maximal expiratory effort
Measured: 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
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start4 Nov 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryan Taylor, Mayo Clinic
- Investigators
- Bryan Taylor, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913129
- Sponsor's protocol ID
- 21-002693
- Status last verified
- Mar 2025
- First submitted
- 31 May 2021
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Burden of COVID-19 Survivorship: Exercise Therapy to Combat the Sequelae of COVID-19
- ClinicalTrials.gov ID
- NCT04913129
- Acronym / sponsor ID
- 21-002693
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Standard physician-guided medical care after COVID-19 |
| Interventional (exercise training) Group | Experimental | Other: Exercise Training8 week home-based exercise training |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Training8 week home-based exercise therapy 4-5 times/week | Other | Interventional (exercise training) Group |
Primary outcome
Maximal oxygen update (VO2max) measured in mL/kg/min
Time frame: 8 weeks
VO2max is the maximal oxygen consumed during an exhaustive exercise test
7 secondary outcomes
Peak exercise work rate (Wpeak) measured in Watts
Time frame: 8 weeks
Forced vital capacity (FVC) measured in L
Time frame: 8 weeks
Forced expiratory volume in 1 second (FEV1) measured in L
Time frame: 8 weeks
Maximal inspiratory pressure (MIP) measured in cmH2O
Time frame: 8 weeks
Maximal expiratory pressure (MEP) measured in cmH2O
Time frame: 8 weeks
Left ventricular contractile function measured as % fractional area change (LV FAC)
Time frame: 8 weeks
Right ventricular contractile function measured as % fractional area change (RV FAC)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Taylor, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training in people with Covid19, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal oxygen update (VO2max) measured in mL/kg/min (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.