COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE)
- Conditions
- COVID-19
- Registration Number
- NCT04595773
- 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; 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 6 minute walk test distance Baseline, 10 weeks, 20 weeks (for cross-over group) 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
Name Time Method Patient reported outcomes and quality of life Baseline, 10 weeks, 20 weeks (for cross-over group), every 3 months for 1 year after exercise 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 Baseline, 10 weeks, 20 weeks (for cross-over group), every 3 months for 1 year after exercise Quantification of free-living physical activity and sleep quality and patterns using wearable accelerometer device.
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States
National Institutes of Health Clinical Center🇺🇸Bethesda, Maryland, United States