20 Participants Needed

Cardiac Rehabilitation for Post-COVID Syndrome

(CARE BEAR-LC Trial)

MS
Overseen ByMatthew S Durstenfeld, MD MAS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is cardiac rehabilitation safe for humans?

Exercise therapy, which is a key part of cardiac rehabilitation, is generally safe for humans and has been shown to improve heart and lung fitness in cancer survivors, even when done at home.12345

How is the Cardiac Rehabilitation treatment for Post-COVID Syndrome different from other treatments?

Cardiac Rehabilitation for Post-COVID Syndrome is unique because it combines exercise therapy with telehealth to improve heart and lung fitness, which is not a standard approach for this condition. This treatment model, adapted from cardio-oncology rehabilitation, is designed to be accessible even during pandemic restrictions, offering a novel way to support recovery at home.12356

What data supports the effectiveness of the treatment Cardiac Rehabilitation for Post-COVID Syndrome?

Research shows that cardiac rehabilitation can improve exercise capacity, muscle strength, and quality of life in post-COVID-19 patients, as seen in a case series where patients increased their walking distance and muscle strength after a rehabilitation program.23789

Who Is on the Research Team?

MS

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.
See 2 more

Exclusion Criteria

I need home oxygen therapy for my chronic lung condition.
I was diagnosed with acute myocarditis less than 3 months ago.
I get significantly worse after physical activity, preventing me from participating in heart rehab.
See 8 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Cardiac RehabilitationExperimental Treatment1 Intervention
Participants will undergo 12 weeks of standard of care cardiac rehabilitation.
Group II: Control ArmActive Control1 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

Find a Clinic Near You

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

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.
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]
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.
Exercise Training for Cancer Survivors.Tong, CKW., Lau, B., Davis, MK.[2021]
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.
Cardiopulmonary rehabilitation in post-COVID-19 patients: case series.Tozato, C., Ferreira, BFC., Dalavina, JP., et al.[2021]

Citations

Research Quality and Impact of Cardiac Rehabilitation in Cancer Survivors: A Systematic Review and Meta-Analysis. [2022]
Exercise Training for Cancer Survivors. [2021]
[Cardiac rehabilitation: physiologic basis, beneficial effects and contraindications]. [2018]
The impact of COVID-19 pandemic on cardiac rehabilitation of patients following acute coronary syndrome. [2023]
Cardiopulmonary rehabilitation in post-COVID-19 patients: case series. [2021]
Cardio-Oncology rehabilitation- challenges and opportunities to improve cardiovascular outcomes in cancer patients and survivors. [2021]
Adherence, safety, and satisfaction of a cardio-oncology rehabilitation program framework versus community exercise training for cancer survivors: findings from the CORE trial. [2023]
Home-based cardio-oncology rehabilitation using a telerehabilitation platform in hematological cancer survivors: a feasibility study. [2023]
Cardio-Oncology Rehabilitation and Telehealth: Rationale for Future Integration in Supportive Care of Cancer Survivors. [2022]
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