COVID-19NCT04595773
COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE)
A study testing Aerobic Exercise Training and Education in people with COVID-19, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: People who are recovering from COVID-19 may continue to have problems that affect their daily life. For instance, they might feel overly tired. Researchers want to learn if exercise can help people recover after COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Aerobic Exercise Training and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Screening procedures will be performed as part of this study. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, aged 18 to 80 years
- Previous infection with SARS-CoV2 at least 4 weeks prior to enrollment, confirmed by laboratory or a healthcare provider. Participants with a documented positive home antigen test will need confirmation of positive COVID-19 antibodies (positive anti-Nucleocapsid antibody test, OR positive anti-Spike antibody test if unvaccinated at the time of the antibody test) to be considered.
- Presence of physical limitations or significant fatigue since COVID-19 as demonstrated by:
- Total score <= 19 on the Patient-Reported Outcomes Measurement Information System (PROMIS) short form for physical function or total score >= 9 on the PROMIS short form for fatigue, AND
- Score >= 1 on the Patient Global Rating of Flu Severity and Patient Global Assessment of Interference with Daily Activities
Show all 13Show fewer
- Absence of post-exertional malaise (PEM) as identified on the DePaul Symptom Questionnaire Post-Exertional Malaise (DSQ-PEM) where:
- Items 1 to 5 has no score >= 2 for frequency and no score >= 2 for severity, occurring in the same row, AND
- Item 7 or 8 is No, AND
- Item 9 is <= 13 hours
- Able to read, speak and understand English or Spanish
- Able to understand and willing to sign a written informed consent document
- Willing and able to complete study procedures
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Above normal performance (i.e., >=100% predicted) in the 6MWT based on normative data for gender and age
- History or cardiac condition as determined by NIH cardiology to be unsafe for exercise participation (e.g. ischemic heart disease, right- or left-sided heart failure, cor pulmonale or pulmonary hypertension, dilated or hypertrophic cardiomyopathy or non-idiopathic cardiomyopathy)
- Significant hepatic or renal dysfunction
- Cancer diagnosis with evidence of metastasis or a life expectancy of less than one year
- History of stroke resulting in impairments in functional mobility that limits safe participation
Show all 16Show fewer
- Active substance abuse including ethyl alcohol (EtOH)
- Severe psychiatric disease, not responsive to treatment or medication
- History of diabetes and on insulin pump therapy, or uncontrolled diabetes with HbA1c > 9.0%
- Pregnancy
- Acceptance onto a lung transplant waiting list
- Extreme obesity with BMI > 40 kg/m2
- On medications that would influence exercise performance such as beta blockers or antiretroviral therapy
- Ongoing tobacco and/or nicotine product use
- Enrolled in another interventional clinical research trial
- Any other medical or health condition(s) that unduly increases the risk of exercise testing or training, affects the normal physiologic response to exercise testing or training, and/or would otherwise interfere with the ability to interpret the data as determined by the PI
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE): A Randomized Controlled Trial
Background:
People who are recovering from COVID-19 may continue to have problems that affect their daily life. For instance, they might feel overly tired. Researchers want to learn if exercise can help people recover after COVID-19 infection.
Read more
Objective:
To study if participation in a rehabilitation exercise program can help people recovering from COVID-19.
Eligibility:
Adults ages 18-80 with a lab-confirmed SARS-CoV2 infection (the virus that causes COVID-19), and are still having some symptoms.
Design:
Participants will have a medical history and physical exam. They will give blood and urine samples. They will have tests to measure heart and lung function. Their blood vessels will be assessed.
Participants will have a computed tomography scan of the body. They will have an ultrasound of the muscles in their arms, legs, and chest.
Participants will take a 6-minute walk test (6MWT). They will take other balance and movement tests.
Participants will walk on a treadmill while hooked up to a monitor. Then they will be interviewed. It will be audio-recorded.
Participants will complete surveys about their symptoms and daily activities.
Participants will take a smell test. For this, they will identify different smells. They will also have memory, attention, and mental functioning tests.
Participants will wear an activity monitor on their wrist 24 hours a day. They will exercise 3 times a week for 10 weeks by performing cardio-type exercise for 30 minutes. They will attend education classes once a week for 10 weeks.
Participants will be contacted by phone or email every 3 months for 1 year after they complete the exercise part of the study. They will wear an activity monitor for up to 2 weeks.
Read the detailed description
Study Description:
This randomized controlled trial will determine whether aerobic exercise training has a beneficial effect on physical function, health-related quality of life, free-living physical activity and sleep quality among survivors of COVID-19. Participants will be randomized to either an aerobic exercise training and education (AET+) group or a control education only group (CON) for 10 weeks. Assessments for physical function, self-reported health outcomes for quality of life (QOL), free-living physical activity and sleep quality will be measured at baseline and following the 10-week intervention period. Participants in the CON group will then crossover and perform AET after the 10-week follow-up visit. All participants will be monitored for one year to capture free-living physical activity, sleep quality and health-related QOL outcomes over time. It is hypothesized that following 10 weeks, physical function, health-related QOL, free-living physical activity and sleep quality will show greater improvement with AET+.
Objectives:
Primary Objective:
To examine the effect of aerobic exercise training on physical function in participants recovering from COVID-19.
Secondary Objectives:
To examine the effect of aerobic exercise training on patient reported outcomes and other health-related QOL components in participants recovering from COVID-19; To examine the effect of aerobic exercise training on free-living physical activity and sleep quality in participants recovering from COVID-19.
Exploratory Objectives:
To explore the effect of aerobic exercise training on clinical outcomes, cardiorespiratory function, cognition, biomarkers, metabolomics, ultrasound-based muscle measurements, and vascular function in participants recovering from COVID-19; To explore the feasibility of conducting the AET program remotely in the crossover CON group of participants recovering from COVID-19; To explore follow-up physical activity, sleep quality and health-related QOL outcomes over 1 year in participants recovering from COVID-19.
Endpoints:
Primary Endpoints:
Physical function as measured by distance walked during the 6-minute walk test after 10 weeks post-randomization with AET+ and CON.
Secondary Endpoints:
Patient-reported outcomes and other health-related components after 10 weeks post-randomization with AET+ and CON; Free-living physical activity and sleep quality after 10 weeks post-randomization with AET+ and CON.
Exploratory Endpoints:
Clinical outcomes, cardiorespiratory function, cognition, biomarkers, metabolomics, ultrasound-based muscle measurements, and vascular function after 10 weeks post-randomization with AET+ and CON; collection of initial feasibility data to conduct exercise sessions remotely; explore relationships between the physiological variables and post-study health outcome variables over time.
- Conditions
- COVID-19
- Being tested
- Aerobic Exercise Training, Education
- Keywords
- Aerobic Exercise Training, Physical Function, Physical Activity, Convalescence, SARS-CoV-2
- Medical subject headings
- COVID-19, Motor Activity, Convalescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingOther
Aerobic exercise training will consist of 10 weeks of aerobic exercise, performed 3 times/week for 30 minutes. Each session will include a warm-up and cool-down period. The intensity will be guided by heart rate and gradually increased from light-moderate to moderate-high intensity as safely tolerated by the subject. All sessions are supervised by credentialed Rehabilitation Medicine Department staff members.
EducationOther
Education consisting of weekly lectures lasting approximately 1 hour for 10 weeks. Topics related to exercise programming, safety and well-being will be covered. Conducted remotely by credential Rehabilitation Medicine Department staff members.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Intervention (AET+) | Experimental | Participants post-acute infection from SARS-CoV-2 with persistent sequelae performed aerobic exercise three times a week plus weekly education for 10 weeks. Receives: Other: Aerobic Exercise Training; Other: Education |
| Control Group (CON) | Other | Participants post-acute infection from SARS-CoV-2 with persistent sequelae performed weekly education for 10 weeks, then crossed over to perform aerobic exercise three times a week for 10 weeks. Receives: Other: Aerobic Exercise Training; Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-minute Walk Test Distance (6MWD)
The 6-minute walk test (6MWT) is a measure of physical capacity and subjects are instructed to walk as far as possible around a pre-measured walking course over a time period of six minutes. The 6-minute walk test distance (6MWD) is the total distance walked in meters during the 6MWT and greater distance walked means better physical capacity. This outcome is reported as the difference between time-points (post- minus pre-10 weeks).
Measured: Before and after 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start22 Jan 2021
- Primary completion5 May 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Leighton Chan, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595773
- Sponsor's protocol ID
- 10000102
- Other IDs
- 000102-CC
- Status last verified
- Jul 2026
- First submitted
- 20 Oct 2020
- Last updated
- 12 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results will be posted on ClinicalTrials.gov and published in peer-reviewed journals. De-identified data from this study may be shared with NIH collaborators and qualified researchers after completion of the primary analyses, in accordance with NIH policies.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04595773
- Acronym / sponsor ID
- 10000102
- Conditions
- COVID-19
- Keywords
- Aerobic Exercise Training, Physical Function, Physical Activity, Convalescence, SARS-CoV-2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 12 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
People who are recovering from COVID-19 may continue to have problems that affect their daily life. For instance, they might feel overly tired. Researchers want to learn if exercise can help people recover after COVID-19 infection.
Objective:
To study if participation in a rehabilitation exercise program can help people recovering from COVID-19.
Eligibility:
Adults ages 18-80 with a lab-confirmed SARS-CoV2 infection (the virus that causes COVID-19), and are still having some symptoms.
Design:
Participants will have a medical history and physical exam. They will give blood and urine samples. They will have tests to measure heart and lung function. Their blood vessels will be assessed.
Participants will have a computed tomography scan of the body. They will have an ultrasound of the muscles in their arms, legs, and chest.
Participants will take a 6-minute walk test (6MWT). They will take other balance and movement tests.
Participants will walk on a treadmill while hooked up to a monitor. Then they will be interviewed. It will be audio-recorded.
Participants will complete surveys about their symptoms and daily activities.
Participants will take a smell test. For this, they will identify different smells. They will also have memory, attention, and mental functioning tests.
Participants will wear an activity monitor on their wrist 24 hours a day. They will exercise 3 times a week for 10 weeks by performing cardio-type exercise for 30 minutes. They will attend education classes once a week for 10 weeks.
Participants will be contacted by phone or email every 3 months for 1 year after they complete the exercise part of the study. They will wear an activity monitor for up to 2 weeks.
Detailed description
Study Description:
This randomized controlled trial will determine whether aerobic exercise training has a beneficial effect on physical function, health-related quality of life, free-living physical activity and sleep quality among survivors of COVID-19. Participants will be randomized to either an aerobic exercise training and education (AET+) group or a control education only group (CON) for 10 weeks. Assessments for physical function, self-reported health outcomes for quality of life (QOL), free-living physical activity and sleep quality will be measured at baseline and following the 10-week intervention period. Participants in the CON group will then crossover and perform AET after the 10-week follow-up visit. All participants will be monitored for one year to capture free-living physical activity, sleep quality and health-related QOL outcomes over time. It is hypothesized that following 10 weeks, physical function, health-related QOL, free-living physical activity and sleep quality will show greater improvement with AET+.
Objectives:
Primary Objective:
To examine the effect of aerobic exercise training on physical function in participants recovering from COVID-19.
Secondary Objectives:
To examine the effect of aerobic exercise training on patient reported outcomes and other health-related QOL components in participants recovering from COVID-19; To examine the effect of aerobic exercise training on free-living physical activity and sleep quality in participants recovering from COVID-19.
Exploratory Objectives:
To explore the effect of aerobic exercise training on clinical outcomes, cardiorespiratory function, cognition, biomarkers, metabolomics, ultrasound-based muscle measurements, and vascular function in participants recovering from COVID-19; To explore the feasibility of conducting the AET program remotely in the crossover CON group of participants recovering from COVID-19; To explore follow-up physical activity, sleep quality and health-related QOL outcomes over 1 year in participants recovering from COVID-19.
Endpoints:
Primary Endpoints:
Physical function as measured by distance walked during the 6-minute walk test after 10 weeks post-randomization with AET+ and CON.
Secondary Endpoints:
Patient-reported outcomes and other health-related components after 10 weeks post-randomization with AET+ and CON; Free-living physical activity and sleep quality after 10 weeks post-randomization with AET+ and CON.
Exploratory Endpoints:
Clinical outcomes, cardiorespiratory function, cognition, biomarkers, metabolomics, ultrasound-based muscle measurements, and vascular function after 10 weeks post-randomization with AET+ and CON; collection of initial feasibility data to conduct exercise sessions remotely; explore relationships between the physiological variables and post-study health outcome variables over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Intervention (AET+) | Experimental | Other: Aerobic Exercise Training, Other: EducationParticipants post-acute infection from SARS-CoV-2 with persistent sequelae performed aerobic exercise three times a week plus weekly education for 10 weeks. |
| Control Group (CON) | Other | Other: Aerobic Exercise Training, Other: EducationParticipants post-acute infection from SARS-CoV-2 with persistent sequelae performed weekly education for 10 weeks, then crossed over to perform aerobic exercise three times a week for 10 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Screening procedures will be performed as part of this study. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, aged 18 to 80 years
- Previous infection with SARS-CoV2 at least 4 weeks prior to enrollment, confirmed by laboratory or a healthcare provider. Participants with a documented positive home antigen test will need confirmation of positive COVID-19 antibodies (positive anti-Nucleocapsid antibody test, OR positive anti-Spike antibody test if unvaccinated at the time of the antibody test) to be considered.
- Presence of physical limitations or significant fatigue since COVID-19 as demonstrated by:
- Absence of post-exertional malaise (PEM) as identified on the DePaul Symptom Questionnaire Post-Exertional Malaise (DSQ-PEM) where:
Key exclusion criteria (16 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Above normal performance (i.e., >=100% predicted) in the 6MWT based on normative data for gender and age
- History or cardiac condition as determined by NIH cardiology to be unsafe for exercise participation (e.g. ischemic heart disease, right- or left-sided heart failure, cor pulmonale or pulmonary hypertension, dilated or hypertrophic cardiomyopathy or non-idiopathic cardiomyopathy)
- Significant hepatic or renal dysfunction
- Cancer diagnosis with evidence of metastasis or a life expectancy of less than one year
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 |
|---|---|---|
| Aerobic Exercise TrainingAerobic exercise training will consist of 10 weeks of aerobic exercise, performed 3 times/week for 30 minutes. Each session will include a warm-up and cool-down period. The intensity will be guided by heart rate and gradually increased from light-moderate to moderate-high intensity as safely tolerated by the subject. All sessions are supervised by credentialed Rehabilitation Medicine Department staff members. | Other | Aerobic Exercise Intervention (AET+), Control Group (CON) |
| EducationEducation consisting of weekly lectures lasting approximately 1 hour for 10 weeks. Topics related to exercise programming, safety and well-being will be covered. Conducted remotely by credential Rehabilitation Medicine Department staff members. | Other | Aerobic Exercise Intervention (AET+), Control Group (CON) |
Primary outcome
Change in 6-minute Walk Test Distance (6MWD)
Time frame: Before and after 10 weeks
The 6-minute walk test (6MWT) is a measure of physical capacity and subjects are instructed to walk as far as possible around a pre-measured walking course over a time period of six minutes. The 6-minute walk test distance (6MWD) is the total distance walked in meters during the 6MWT and greater distance walked means better physical capacity. This outcome is reported as the difference between time-points (post- minus pre-10 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study results will be posted on ClinicalTrials.gov and published in peer-reviewed journals. De-identified data from this study may be shared with NIH collaborators and qualified researchers after completion of the primary analyses, in accordance with NIH policies.
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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.
Leighton Chan, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Training and Education in people with COVID-19, run by National Institutes of Health Clinical Center (CC) 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 13 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. 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?
Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in 6-minute Walk Test Distance (6MWD) (time frame: Before and after 10 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 12 Aug 2026.