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Protocol Details

COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE): A Randomized Controlled Trial

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 80 Years

Referral Letter Required


Population Exclusion(s)



Aerobic Exercise Training;
Physical Function;
Physical Activity;

Recruitment Keyword(s)




Investigational Drug(s)


Investigational Device(s)



Other: Aerobic Exercise Training
Other: Education

Supporting Site

NIH Clinical Center


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.


To study if participation in a rehabilitation exercise program can help people recovering from COVID-19.


Adults ages 18-80 with a lab-confirmed SARS-CoV2 infection (the virus that causes COVID-19), and are still having some symptoms.


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. 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 moving vigorously on a track or treadmill 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.

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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 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

-Absence of post-exertional malaise (PEM) as identified on the 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


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

-Active substance abuse including 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%


-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

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Leighton Chan, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CRC BG RM 1-1469
(301) 496-4733

National Institutes of Health Clinical Center (CC)

Not Listed

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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