Background:People who are recovering from COVID-19 may continue to have problems that affect theirdaily life. For instance, they might feel overly tired. Researchers want to learn ifexercise can help people recover after COVID-19 infection.Objective:To study if participation in a rehabilitation exercise program can help people recoveringfrom COVID-19.Eligibility:Adults ages 18-80 with a lab-confirmed SARS-CoV2 infection (the virus that causesCOVID-19), and are still having some symptoms.Design:Participants will have a medical history and physical exam. They will give blood andurine samples. They will have tests to measure heart and lung function. Their bloodvessels will be assessed.Participants will have a computed tomography scan of the body. They will have anultrasound of the muscles in their arms, legs, and chest.Participants will take a 6-minute walk test. They will take other balance and movementtests.Participants will walk on a treadmill while hooked up to a monitor. Then they will beinterviewed. 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. Theywill also have memory, attention, and mental functioning tests.Participants will wear an activity monitor on their wrist 24 hours a day. They willexercise 3 times a week for 10 weeks by moving vigorously on a track or treadmill for 30minutes. 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 theycomplete the exercise part of the study. They will wear an activity monitor for up to 2weeks.
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.
Other: Aerobic Exercise Training
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.
Other: Education
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.
- 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 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
EXCLUSION CRITERIA:
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
- 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
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Leighton Chan, M.D., Principal Investigator
National Institutes of Health Clinical Center (CC)