COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE)
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.
Conditions:
🦠 COVID-19
🗓️ Study Start (Actual) 22 January 2021
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 90
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Bethesda, Maryland, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 October 2020
  • First Submitted that Met QC Criteria 20 October 2020
  • First Posted 22 October 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 July 2024
  • Last Update Posted 26 July 2024
  • Last Verified 24 July 2024