COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE) (NCT04595773) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE)
United States48 participantsStarted 2021-01-22
Plain-language 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.
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
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
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in 6-minute Walk Test Distance (6MWD)
Timeframe: Before and after 10 weeks
Trial details
NCT IDNCT04595773
SponsorNational Institutes of Health Clinical Center (CC)