Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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: 1. Male or female, aged 18 to 80 years 2. Previous laboratory-confirmed infection with SARS-CoV2 3. Considered non-infectious with COVID-19 as demonstrated by: 1. Greater than or equal to 28 days since initial onset of symptoms or initial positive test date, (for asymptomatic infection), and greater than or equal to 72 hours since resolution of fever (without fever-reducing medication), and symptoms (e.g. cough, shortness of breath) have improved, OR 2. Greater than or equal to 10 days since initial positive test date, and at least 2 consecutive nasopharyngeal or oropharyngeal swabs collected greater than or equal to 24 hours apart that are negative for SARS-CoV2 4. Presence of physical limitations or significant fatigue since COVID-19 as demonstrated by: 1. 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 2. Score greater than or equal to 1 on the Patient Global Rating of Flu Severity and Patient Global Assessment of Interference with Daily Activities 5. Able to read, speak and understand English or Spanish 6. Able to understand and willing to sign a written informed consent document 7. 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: 1. Above normal performance (i.e, greater than or equal to 100% predicted) in the 6MWT based on normative data for gender and age (85,86) 2. 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) 3. Significant hepatic or renal dysfunction 4. Cancer diagnosis with evidence of metastasis or a life expectancy of less than one year 5. History of stroke resulting in impairments in functional mobility that limits safe participation 6. Active substance abuse including EtOH 7. Severe psychiatric disease, not responsive to treatment or medication 8. History of diabetes and on insulin pump therapy, or uncontrolled diabetes with HbA1c > 9.0% 9. Pregnancy 10. Acceptance onto a lung transplant waiting list 11. Extreme obesity with BMI > 40 kg/m2 12. On medications that would influence exercise performance such as beta blockers or antiretroviral therapy 13. Ongoing tobacco and/or nicotine product use 14. Enrolled in another interventional clinical research trial 15. 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 INCLUSION OF VULNERABLE PARTICIPANTS: Participation of Employees: NIH employees may be enrolled in this study as this population meets the study entry criteria. Neither participation nor refusal to participate as a participant in the research will have an effect, either beneficial or adverse, on the participant s employment or position at NIH. Every effort will be made to protect participant information, but such information may be available in medical records and may be available to authorized users outside of the study team in both an identifiable and unidentifiable manner. The NIH Information Sheet on Employee Research Participation will be made available.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Aerobic Exercise Training and Education (AET+)
Participants will perform both exercise training and education for 10 weeks
  • 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.
Other
Education only (CON)
Participants will perform only education for the first 10 weeks, then cross-over to perform exercise in the second 10 weeks
  • 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.

Recruiting Locations

National Institutes of Health Clinical Center
Bethesda, Maryland 20892
Contact:
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
800-411-1222
prpl@cc.nih.gov

More Details

NCT ID
NCT04595773
Status
Recruiting
Sponsor
National Institutes of Health Clinical Center (CC)

Study Contact

COVID-CARE Rehab Team
Not Listed
covidcarerehabteam@nih.gov

Detailed Description

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. Study Population: Ninety male and female adults (18 to 80 years old) recovering from COVID-19, from the greater Washington DC metropolitan area. Description of Sites/Facilities Enrolling Participants: Single-site study (NIH Clinical Center) Description of Study Intervention: Aerobic Exercise Training: Participants will perform aerobic exercise, 3 times a week for 10 weeks, with supervision by credentialed RMD staff members. Participants will be encouraged to target 30 minutes of continuous aerobic exercise. The intensity of exercise will be gradually increased from light-moderate to moderate-high as safely tolerated by the participant and guided using heart rate targets. Education: Participants will have weekly education sessions for 10 weeks. All sessions are approximately 1 hour and will be conducted remotely by credentialed RMD staff members. Participants randomized to AET+ will perform both exercise training and education during the 10 week intervention period. Participants randomized to CON will perform education only during the first 10 weeks, followed by exercise training during the second 10 weeks (crossover). Study Duration: 36 months Participant Duration: Up to 16 months if randomized to AET+, and up to 19 months if randomized to CON

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.