COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Aerobic Exercise Training, Physical Function, Physical Activity, Convalescence, SARS-CoV-2
Eligibility Criteria
- 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, confirmed by laboratory or a healthcare provider-administered test at least 4 weeks prior to enrollment. 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 less than or equal to 19 on the PROMIS short form for physical function or total score greater than or equal to 9 on the PROMIS short form for fatigue, AND
- Score greater than or equal to 1 on the Patient Global Rating of Flu Severity and Patient Global Assessment of Interference with Daily Activities
- 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, greater than or equal to 100% predicted) in the 6MWT based on normative data for gender and age (86,87)
- 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/m^2
- 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
Sites / Locations
- National Institutes of Health Clinical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Aerobic Exercise Training and Education (AET+)
Education only (CON)
Participants will perform both exercise training and education for 10 weeks
Participants will perform only education for the first 10 weeks, then cross-over to perform exercise in the second 10 weeks