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Exercise for COVID-19 Recovery
Phase 1 & 2
Recruiting
Led By Leighton Chan, M.D.
Research Sponsored by National Institutes of Health Clinical Center (CC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 10 weeks, 20 weeks (for cross-over group), every 3 months for 1 year after exercise
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at whether exercise can help people recover from COVID-19.
Who is the study for?
Adults aged 18-80 who had COVID-19 and are still experiencing symptoms like fatigue or physical limitations can join. They must understand English or Spanish, agree to the study's procedures, and have confirmed past infection with lab tests. People with severe psychiatric issues, certain medical conditions, extreme obesity (BMI > 40), or on conflicting medications cannot participate.
What is being tested?
The trial is testing if a rehabilitation exercise program helps recovery from COVID-19. Participants will do aerobic exercises three times a week for ten weeks and attend educational classes. They'll also be monitored through various health tests including heart and lung function, muscle ultrasounds, walking tests, surveys about their daily activities, smell tests, and mental functioning exams.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of participating in an aerobic exercise training program may include muscle soreness, fatigue during initial stages of the regimen due to increased activity levels after a period of illness-related inactivity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 10 weeks, 20 weeks (for cross-over group), every 3 months for 1 year after exercise
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 10 weeks, 20 weeks (for cross-over group), every 3 months for 1 year after exercise
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
6 minute walk test distance
Secondary study objectives
Free-living physical activity and sleep quality
Patient reported outcomes and quality of life
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Education only (CON)Experimental Treatment2 Interventions
Participants will perform only education for the first 10 weeks, then cross-over to perform exercise in the second 10 weeks
Group II: Aerobic Exercise Training and Education (AET+)Experimental Treatment2 Interventions
Participants will perform both exercise training and education for 10 weeks
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Who is running the clinical trial?
National Institutes of Health Clinical Center (CC)Lead Sponsor
388 Previous Clinical Trials
30,879,821 Total Patients Enrolled
Leighton Chan, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
8 Previous Clinical Trials
599 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I performed above average in a 6-minute walk test for my age and gender.I am taking medication that could affect my ability to exercise, like beta blockers.I have a heart condition that makes exercise unsafe.I have diabetes and use an insulin pump or my HbA1c is above 9.0%.I have serious liver or kidney problems.I had a stroke that affects my ability to move safely.I can read, speak, and understand English or Spanish.I don't experience severe fatigue after physical activity.My cancer has spread, or I have been told I have less than a year to live.My BMI is over 40.I had COVID-19 confirmed by a test or doctor at least 4 weeks ago.I am between 18 and 80 years old.I am willing and able to follow the study's procedures.I have physical limitations or significant fatigue from COVID-19, as shown by specific test scores.
Research Study Groups:
This trial has the following groups:- Group 1: Education only (CON)
- Group 2: Aerobic Exercise Training and Education (AET+)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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