COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE)
2 other identifiers
interventional
48
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 covid19
Started Jan 2021
Longer than P75 for phase_1 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
January 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedJune 12, 2025
June 10, 2025
4.3 years
October 20, 2020
June 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6 minute walk test distance
The 6MWT distance has been used to reflect longitudinal changes in physical function among patients with acute lung disease and SARS. A minimal important difference (MID) has yet to be established among survivors of COVID-19. We will consider 30 meters as the MID for this study based on reported ranges of 20 to 30 meters in patients with lung disease.
Baseline, 10 weeks, 20 weeks (for cross-over group)
Secondary Outcomes (2)
Patient reported outcomes and quality of life
Baseline, 10 weeks, 20 weeks (for cross-over group), every 3 months for 1 year after exercise
Free-living physical activity and sleep quality
Baseline, 10 weeks, 20 weeks (for cross-over group), every 3 months for 1 year after exercise
Study Arms (2)
Aerobic Exercise Training and Education (AET+)
EXPERIMENTALParticipants will perform both exercise training and education for 10 weeks
Education only (CON)
OTHERParticipants will perform only education for the first 10 weeks, then cross-over to perform exercise in the second 10 weeks
Interventions
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 RMD staff members.
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 RMD staff members.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leighton Chan, M.D.
National Institutes of Health Clinical Center (CC)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2020
First Posted
October 22, 2020
Study Start
January 22, 2021
Primary Completion
May 5, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
June 12, 2025
Record last verified: 2025-06-10