NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE): A Randomized Controlled Trial

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000102-CC

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 80 Years

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

COVID-19

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: Aerobic Exercise Training
Other: Education

Supporting Site

NIH Clinical Center

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.

--Back to Top--

Eligibility

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:

a. 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

b. 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:

a. 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

b. 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.


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Leighton Chan, M.D.
National Institutes of Health Clinical Center (CC)



COVID-CARE Rehab Team
National Institutes of Health Clinical Center (CC)

Not Listed
covidcarerehabteam@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT04595773

--Back to Top--