COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE)

NCT04595773 | Active Not Recruiting Results

• 2 other identifiers: 10000102000102-CC
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 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 (6MWT). 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 performing cardio-type exercise 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

Keywords

Aerobic Exercise Training; Physical Function; Physical Activity; Convalescence; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Change in 6-minute Walk Test Distance (6MWD)

  The 6-minute walk test (6MWT) is a measure of physical capacity and subjects are instructed to walk as far as possible around a pre-measured walking course over a time period of six minutes. The 6-minute walk test distance (6MWD) is the total distance walked in meters during the 6MWT and greater distance walked means better physical capacity. This outcome is reported as the difference between time-points (post- minus pre-10 weeks).

  Before and after 10 weeks

Study Arms (2)

Aerobic Exercise Intervention (AET+)

EXPERIMENTAL

Participants post-acute infection from SARS-CoV-2 with persistent sequelae performed aerobic exercise three times a week plus weekly education for 10 weeks.

Other: Aerobic Exercise Training; Other: Education

Control Group (CON)

OTHER

Participants post-acute infection from SARS-CoV-2 with persistent sequelae performed weekly education for 10 weeks, then crossed over to perform aerobic exercise three times a week for 10 weeks.

Other: Aerobic Exercise Training; Other: Education

Interventions

Aerobic Exercise Training OTHER

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 Rehabilitation Medicine Department staff members.

Aerobic Exercise Intervention (AET+); Control Group (CON)

Education OTHER

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 Rehabilitation Medicine Department staff members.

Aerobic Exercise Intervention (AET+); Control Group (CON)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 Patient-Reported Outcomes Measurement Information System (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 DePaul Symptom Questionnaire Post-Exertional Malaise (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 ethyl alcohol (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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

COVID-19; Motor Activity; Convalescence

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Limitations and Caveats

Due to low recruitment, study was stopped before reaching target enrollment numbers.

Results Point of Contact

• Title: Dr. Leighton Chan
• Organization: National Institutes of Health Clinical Center (NIH CC)

chanle@mail.nih.gov

1 301 496 4300

Study Officials

• Leighton Chan, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: May 12, 2026
• Results First Posted: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified data from this study may be shared after completion of the primary analyses and publication of results.
• Access Criteria: Data from this study may be requested from other researchers after the completion of the primary endpoint by contacting the principal investigator.

Locations

US (1)