Cardiac Rehabilitation for Post-COVID Syndrome

(CARE BEAR-LC Trial)

Overseen By Matthew S Durstenfeld, MD MAS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Beta-blockers, Calcium channel blockers

Disqualifiers: Pregnancy, Heart disease, Arrhythmias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cardiac rehabilitation can enhance exercise ability and heart rate during activities for people with Long COVID. Participants will either join a 12-week rehab program or be in a no-treatment group for comparison. Individuals who had COVID-19, continue to experience symptoms for at least 3 months, and struggle with exercise might be suitable candidates. The goal is to assess whether rehab can improve overall health and daily function for these individuals. As an unphased trial, this study provides a unique opportunity to contribute to understanding how rehabilitation can benefit those with Long COVID.

Will I have to stop taking my current medications?

The trial excludes participants who are using beta-blockers, certain calcium channel blockers, or ivabradine, so you may need to stop these medications to participate.

What prior data suggests that cardiac rehabilitation is safe for individuals with Long COVID?

Research has shown that cardiac rehab is generally safe for patients, including those with heart issues related to Long COVID. One study demonstrated that cardiac rehab improved heart function in individuals with Long COVID and heart disease, with no major safety problems reported. Another study found that a short, focused rehab program had lasting positive effects on symptoms without serious side effects. This evidence suggests that cardiac rehab is well-tolerated and a safe option for improving heart health after COVID-19. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using cardiac rehabilitation for post-COVID syndrome because it offers a structured approach to restoring heart health in individuals affected by lingering COVID-19 symptoms. Unlike standard treatments that may focus primarily on medication, cardiac rehab provides a comprehensive program including exercise, education, and counseling to improve cardiovascular function and overall well-being. This holistic method has the potential to address multiple symptoms simultaneously, offering a promising pathway for those experiencing the long-term effects of COVID-19.

What evidence suggests that cardiac rehabilitation might be an effective treatment for Long COVID?

Research has shown that cardiac rehabilitation, which participants in this trial may receive, can help people with Long COVID feel better. One study found that COVID-19 survivors who underwent cardiac rehab experienced fewer heart problems and lower death rates. Another study found that after completing a cardiac rehab program, patients could walk farther, had less trouble breathing, and felt better emotionally. These results suggest that cardiac rehab might effectively improve exercise ability and heart health for those with Long COVID symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Matthew S Durstenfeld, MD MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have a low exercise capacity and your heart rate doesn't increase enough during a physical test. If it's hard to find enough people for the study, they may include individuals with slightly better exercise capacity.

I have had a confirmed case of COVID-19.

I have had COVID-19 symptoms for more than 90 days.

Exclusion Criteria

I was diagnosed with acute myocarditis less than 3 months ago.

I need home oxygen therapy for my chronic lung condition.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 or more visits (in-person)

Baseline Assessments

Participants undergo baseline assessments including symptom assessments, cardiopulmonary exercise testing, and vascular function studies

1 week

Treatment

Participants undergo 12 weeks of standard of care cardiac rehabilitation, including exercise prescriptions, dietary counseling, and other standard protocols

12 weeks

12-36 sessions (in-person and/or virtual)

Follow-up

Participants complete follow-up assessments to determine the safety, clinical impact, and biological impact of the therapy

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac Rehabilitation

Trial Overview

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.

How Is the Trial Designed?

Group I: Cardiac Rehabilitation Experimental Treatment 1 Intervention

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

Group II: Control Arm Active Control 1 Intervention

No intervention control group

Cardiac Rehabilitation is already approved in United States, European Union for the following indications:

Approved in United States as Cardiac Rehabilitation for:

• Cardiovascular disease prevention in cancer survivors
• Improvement of cardiorespiratory fitness in cancer patients

Approved in European Union as Cardio-Oncology Rehabilitation for:

• Reduction of cardiovascular risk in cancer survivors
• Management of cardiotoxicity related to cancer therapies

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

As the number of cancer survivors increases, so does the risk of cardiovascular disease (CVD) among them, highlighting the need for integrated care in cancer treatment.

Cardio-oncology rehabilitation (CORE) is a new approach designed to reduce CVD risk and enhance fitness in cancer survivors through tailored exercise and cardiac rehabilitation, addressing the emerging issue of cancer treatment-related cardiovascular disease (CTRCD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-Oncology rehabilitation- challenges and opportunities to improve cardiovascular outcomes in cancer patients and survivors. Sase, K., Kida, K., Furukawa, Y.[2021]

Cardiac rehabilitation (CR) for cancer survivors shows low-to-moderate quality in reporting and moderate-to-high risk of bias, which affects the reliability of the findings and their application in clinical practice.

Despite the quality concerns, survivors who completed CR demonstrated improved cardiorespiratory fitness and reduced fatigue compared to those who did not participate in CR, suggesting potential benefits of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research Quality and Impact of Cardiac Rehabilitation in Cancer Survivors: A Systematic Review and Meta-Analysis. Fakhraei, R., Peck BKin, SS., Abdel-Qadir, H., et al.[2022]

Cancer treatments can lead to increased cardiovascular risks, making it important to implement comprehensive cardiac rehabilitation, known as cardio-oncology rehabilitation, to help mitigate these risks.

Telehealth and mobile applications show promise as effective alternatives for delivering cardio-oncology rehabilitation, providing both physiological and psychological benefits to cancer patients and survivors, especially during barriers like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-Oncology Rehabilitation and Telehealth: Rationale for Future Integration in Supportive Care of Cancer Survivors. Batalik, L., Filakova, K., Radkovcova, I., et al.[2022]

The center-based cardiac rehabilitation (CBCR) program showed significantly higher adherence (90.3%) and satisfaction among cancer survivors at increased cardiovascular risk compared to community-based exercise training (CBET) (68.4%).

Both programs were safe, with no major cardiovascular events reported; however, CBCR had fewer exercise-related adverse events (7) compared to CBET (20), indicating a potentially safer environment for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence, safety, and satisfaction of a cardio-oncology rehabilitation program framework versus community exercise training for cancer survivors: findings from the CORE trial. Viamonte, SG., Joaquim, A., Alves, A., et al.[2023]

A cardiopulmonary rehabilitation program for post-COVID-19 patients showed significant improvements in functional capacity, with participants increasing their 6-Minute Walk Test distance by 16% to 94% after three months of rehabilitation.

The program also enhanced peripheral muscle strength by 20% to six times the baseline values and reduced the double product at rest by 8% to 42%, indicating a positive impact on overall health despite varying severity levels of the patients' conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiopulmonary rehabilitation in post-COVID-19 patients: case series. Tozato, C., Ferreira, BFC., Dalavina, JP., et al.[2021]

Exercise therapy significantly improves cardiorespiratory fitness in cancer patients and helps reduce the cardiotoxic effects of cancer treatments, making it a crucial part of cardiac rehabilitation programs.

Starting exercise early after a cancer diagnosis and continuing throughout survivorship is generally safe and beneficial for heart health in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training for Cancer Survivors. Tong, CKW., Lau, B., Davis, MK.[2021]

A 12-week home-based cardio-oncology rehabilitation (CORE) program using telerehabilitation was found to be safe and feasible for 11 hematological cancer survivors, with 80% adherence to the exercise sessions.

Participants showed a significant improvement in cardiorespiratory fitness, with an increase of 2.6 ml/kg/min and peak workload, indicating that this intervention can effectively enhance fitness levels in cancer survivors post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based cardio-oncology rehabilitation using a telerehabilitation platform in hematological cancer survivors: a feasibility study. Filakova, K., Janikova, A., Felsoci, M., et al.[2023]

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link.springer.com/article/10.1007/s11357-024-01179-z

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