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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise Training
Education
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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 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.
  3. 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
  4. Able to read, speak and understand English or Spanish
  5. Able to understand and willing to sign a written informed consent document
  6. 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 (86,87)
  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/m^2
  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

Sites / Locations

  • National Institutes of Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Aerobic Exercise Training and Education (AET+)

Education only (CON)

Arm Description

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

Outcomes

Primary Outcome Measures

6 minute walk test distance
The 6MWT distance has been used to reflect longitudinal changes in physical function among patients with acute lung disease and SARS. A minimal important difference (MID) has yet to be established among survivors of COVID-19. We will consider 30 meters as the MID for this study based on reported ranges of 20 to 30 meters in patients with lung disease.

Secondary Outcome Measures

Patient reported outcomes and quality of life
Patient reported outcomes related to fatigue, sleep, post-traumatic stress disorder, depression, anxiety, general and COVID-19 specific QOL outcomes will be captured.
Free-living physical activity and sleep quality
Quantification of free-living physical activity and sleep quality and patterns using wearable accelerometer device.

Full Information

First Posted
October 20, 2020
Last Updated
August 23, 2023
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT04595773
Brief Title
COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE)
Official Title
COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 22, 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. 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.
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; Freeliving 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Aerobic Exercise Training, Physical Function, Physical Activity, Convalescence, SARS-CoV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise Training and Education (AET+)
Arm Type
Experimental
Arm Description
Participants will perform both exercise training and education for 10 weeks
Arm Title
Education only (CON)
Arm Type
Other
Arm Description
Participants will perform only education for the first 10 weeks, then cross-over to perform exercise in the second 10 weeks
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
6 minute walk test distance
Description
The 6MWT distance has been used to reflect longitudinal changes in physical function among patients with acute lung disease and SARS. A minimal important difference (MID) has yet to be established among survivors of COVID-19. We will consider 30 meters as the MID for this study based on reported ranges of 20 to 30 meters in patients with lung disease.
Time Frame
Baseline, 10 weeks, 20 weeks (for cross-over group)
Secondary Outcome Measure Information:
Title
Patient reported outcomes and quality of life
Description
Patient reported outcomes related to fatigue, sleep, post-traumatic stress disorder, depression, anxiety, general and COVID-19 specific QOL outcomes will be captured.
Time Frame
Baseline, 10 weeks, 20 weeks (for cross-over group), every 3 months for 1 year after exercise
Title
Free-living physical activity and sleep quality
Description
Quantification of free-living physical activity and sleep quality and patterns using wearable accelerometer device.
Time Frame
Baseline, 10 weeks, 20 weeks (for cross-over group), every 3 months for 1 year after exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
COVID-CARE Rehab Team
Phone
Not Listed
Email
covidcarerehabteam@nih.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Leighton Chan, M.D.
Phone
(301) 496-4733
Email
chanle@mail.nih.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leighton Chan, M.D.
Organizational Affiliation
National Institutes of Health Clinical Center (CC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Phone
800-411-1222
Ext
TTY8664111010
Email
prpl@cc.nih.gov

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_000102-CC.html
Description
NIH Clinical Center Detailed Web Page

Learn more about this trial

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

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