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NCT04595773 · ClinicalTrials.gov registry record · Phase 1
COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE)
A Phase 1 study of COVID-19, sponsored by National Institutes of Health Clinical Center (CC).
- Active
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT04595773: Active Phase 1 study of COVID-19, sponsored by National Institutes of Health Clinical Center (CC).
NCT04595773 is a Phase 1 study of COVID-19 that is active but no longer recruiting, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 48 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04595773, a Phase 1 study of COVID-19, is active but no longer recruiting, sponsored by National Institutes of Health Clinical Center (CC).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- OTHER Education
- OTHER Aerobic Exercise Training
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-01-22 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04595773 still lists
NCT04595773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Education is the first listed.
NCT04595773 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04595773 about?
NCT04595773 is a clinical study titled "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 rehabilitat...
What is the current status of trial NCT04595773?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2021-01-22. Estimated completion is 2026-12-31.
What conditions does trial NCT04595773 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04595773?
The interventions under investigation include: Education (OTHER), Aerobic Exercise Training (OTHER).
Who is sponsoring clinical trial NCT04595773?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04595773 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04595773's enrollment target sits among peer trials
48 250th of 298 higher than 47 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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