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

N/A

Recruiting

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.

Presence of persistent symptoms, defined as at least one COVID-attributed symptom newly present during acute illness or worse than baseline and reported to still be present for at least 90 days following symptom onset. This will be ascertained using study case report forms.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

CARE BEAR-LC Trial Summary

This trial is testing whether cardiac rehabilitation can help people with long-term symptoms from COVID-19, who have reduced exercise capacity and reduced heart rate response.

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.Check my eligibility

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.See study design

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.

CARE BEAR-LC Trial 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 have had COVID-19 symptoms for more than 90 days.

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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.

CARE BEAR-LC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Peak VO2 (ml/kg/min)

Heart rate

Secondary outcome measures

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

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

Change in Inflammation

+9 more

CARE BEAR-LC 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

~3280

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,501 Previous Clinical Trials

15,236,546 Total Patients Enrolled

22 Trials studying COVID-19

569,435 Patients Enrolled for COVID-19

Matthew S Durstenfeld, MD MASPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Cardiac Rehabilitation Clinical Trial Eligibility Overview. Trial Name: NCT05530317 — N/A

COVID-19 Research Study Groups: Cardiac Rehabilitation

COVID-19 Clinical Trial 2023: Cardiac Rehabilitation Highlights & Side Effects. Trial Name: NCT05530317 — N/A

Cardiac Rehabilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05530317 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new enrollees currently being considered for this research project?

"Accurate, clinicaltrials.gov has marked this medical trial as open for recruitment since December 1st 2022; the most recent alteration was on November 29th of that same year."

Answered by AI

What is the aggregate figure of participants enrolled in this clinical trial?

"Affirmative. Clinicaltrials.gov has documentation of this ongoing medical study, which was initially posted on December 1st 2022 and revised at the end of November that same year. This trial is in search of 25 participants from one hospital or research site."

Answered by AI

What is the prime purpose of this research endeavor?

"The stated goal of this medical trial is to measure the alteration in Peak VO2 (ml/kg/min) over a period of 12 weeks, beginning at Baseline. Secondary objectives include tracking changes in Composite Autonomic Symptom Scale-31 Score (0-100), Peak VO2 as a percentage predicted using Wasserman equations derived from cardiopulmonary testing, and attendance records for both physical and virtual Cardiac Rehabilitation sessions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19

2022. "CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05530317.

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