What is the mechanism of action of this treatment?

The most common treatments for COVID-19 include antiviral medications, such as remdesivir, which inhibit viral replication, and anti-inflammatory drugs like dexamethasone, which reduce the body's inflammatory response to the virus. These treatments are crucial for managing the acute phase of the infection and preventing severe complications. For patients with Long COVID, structured exercise programs, such as cardiac rehabilitation, are important as they help improve cardiovascular health, reduce fatigue, and enhance overall functional capacity. These programs are tailored to the patient's tolerance levels and gradually increase activity, which is essential for recovery and improving quality of life.

What side effects are associated with this type of intervention?

Common treatments for COVID-19 include antiviral medications, corticosteroids, and supportive therapies such as oxygen therapy. Antiviral medications like remdesivir can cause side effects such as nausea, elevated liver enzymes, and potential kidney issues. Corticosteroids like dexamethasone may lead to side effects including hyperglycemia, increased risk of infections, and potential gastrointestinal bleeding. Supportive therapies, including oxygen therapy, generally have fewer side effects but can sometimes cause nasal dryness or discomfort. For treatments involving structured exercise and education, such as cardiac rehabilitation, side effects are minimal but may include muscle soreness and fatigue.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19, including antiviral drugs like remdesivir (Veklury), monoclonal antibodies such as bamlanivimab and etesevimab, and immunomodulators like baricitinib. These treatments primarily target the viral replication process or modulate the immune response to reduce inflammation. While these treatments are not directly related to cardiac rehabilitation, they are part of the broader effort to manage and treat COVID-19. Cardiac rehabilitation, involving structured exercise and education, is being studied for its potential benefits in improving cardiovascular health and exercise capacity in patients with Long COVID.

What other types of research exist?

Promising novel alternatives to traditional cardiac rehabilitation for COVID-19 patients include hybrid rehabilitation programs that combine initial supervised sessions with subsequent sessions in local sport centers or home-based settings. Additionally, cardiac telerehabilitation, which leverages technology to deliver remote exercise and education, is a viable option. These approaches maintain the core components of cardiac rehabilitation while offering flexibility and accessibility.

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Cardiac Rehabilitation for Post-COVID Syndrome (CARE BEAR-LC Trial)

N/A

Waitlist Available

Led By Matthew S Durstenfeld, MD MAS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previously documented SARS-CoV-2 RNA positivity from an oral or nasal swab, as measured by a nucleic acid amplification test, documented positive antigen testing, or positive nucleocapsid antibody. Documentation of the positive test is required.

Willing and able to actively participate in cardiac rehabilitation including attending at least 12 in person sessions at UCSF Parnassus.

Must not have

Chronic lung disease requiring the use of home oxygen therapy

Severe post-exertional malaise or symptom worsening that would preclude participation in cardiac rehabilitation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if cardiac rehabilitation can help people with Long COVID improve their exercise ability and heart function. The program includes exercise training and health education to support heart health and overall well-being.

Who is the study for?

This trial is for adults over 18 who've had COVID-19 and are now experiencing Long COVID symptoms like reduced exercise capacity and heart rate response. They must have had a positive test for the virus, be able to attend cardiac rehab sessions, and not be pregnant or planning pregnancy during the study. People with severe heart conditions, certain arrhythmias, on specific heart medications, or with severe post-exertional malaise cannot participate.

What is being tested?

The trial tests if cardiac rehabilitation can improve exercise ability and heart rate responses in Long COVID patients. Participants will undergo cardiopulmonary exercise testing (CPET) to measure changes in peak oxygen intake (VO2), symptom severity including autonomic symptoms, anxiety, depression levels, endothelial function, and satisfaction with treatment.

What are the potential side effects?

While specific side effects aren't listed for this intervention since it's a form of physical therapy rather than medication-based treatment; participants may experience fatigue or muscle soreness typical of new exercise routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a confirmed case of COVID-19.

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I can attend 12 cardiac rehab sessions at UCSF Parnassus.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need home oxygen therapy for my chronic lung condition.

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I get significantly worse after physical activity, preventing me from participating in heart rehab.

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I've had a recent heart attack, bypass surgery, or been diagnosed with heart failure.

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I am taking beta-blockers, calcium channel blockers, or ivabradine.

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I have a history of serious heart or lung conditions.

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I cannot ride a stationary bike for a fitness test.

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I have a heart rhythm problem that needs medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Peak VO2 (ml/kg/min)

Heart rate

Secondary study objectives

Change in Composite Autonomic Symptom Scale-31 (Compass 31) Score

Change in Generalized Anxiety Disorder Screener (GAD-7) Score

Change in Inflammation

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cardiac RehabilitationExperimental Treatment1 Intervention

Participants will undergo 12 weeks of standard of care cardiac rehabilitation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cardiac Rehabilitation

2016

Completed Phase 4

~3310

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for COVID-19 include antiviral medications, such as remdesivir, which inhibit viral replication, and anti-inflammatory drugs like dexamethasone, which reduce the body's inflammatory response to the virus. These treatments are crucial for managing the acute phase of the infection and preventing severe complications. For patients with Long COVID, structured exercise programs, such as cardiac rehabilitation, are important as they help improve cardiovascular health, reduce fatigue, and enhance overall functional capacity. These programs are tailored to the patient's tolerance levels and gradually increase activity, which is essential for recovery and improving quality of life.