Tailored Cardiac Rehabilitation for Heart Health

(HEART-ACT Trial)

Overseen By Alisa Boyd, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Hospice, Provider restriction

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to cardiac rehabilitation, which aids recovery after heart-related events like a heart attack or surgery. The study compares a personalized rehab program offered within a safety net setting—providing exercise and health advice every other week—to the usual practice of referring patients to an external cardiac rehabilitation program. The researchers aim to determine if this tailored approach improves participation in rehab. Candidates may qualify if they have experienced a heart attack, undergone heart surgery, or have conditions like chronic stable angina, and can communicate in English, Spanish, or Cantonese. As an unphased trial, this study offers a unique opportunity to contribute to innovative cardiac care solutions.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this tailored cardiac rehabilitation program is safe?

Studies have shown that cardiac rehabilitation is generally safe and carries a low risk of complications. Research indicates that these programs can improve heart health and lower the risk of death for individuals with heart issues. Importantly, cardiac rehab is well-tolerated, allowing most participants to engage without problems. Some sources mention various delivery methods, such as home-based or online programs, and find them safe as well. Overall, evidence suggests that participating in a personalized cardiac rehabilitation program is safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tailored cardiac rehabilitation because it offers a personalized approach to heart health that differs from standard programs. Unlike typical cardiac rehab, which often follows a one-size-fits-all model, this treatment includes individualized counseling sessions and group activities every other week. This customized program aims to address the unique needs of each patient, potentially leading to better engagement and outcomes. Additionally, the setting within a safety net hospital could make this approach more accessible to patients who might otherwise face barriers to receiving specialized care.

What evidence suggests that this trial's treatments could be effective for heart health?

This trial will compare two approaches to cardiac rehabilitation: a tailored program in a safety net setting and a referral to an external program. Research has shown that personalized heart health programs can significantly improve heart health. Studies have found that these programs, especially those designed for specific groups like women, enhance overall quality of life. This improvement often leads to better commitment to healthy habits. Additionally, cardiac rehabilitation effectively improves heart health, though managing blood sugar levels may require more focus. Other findings suggest that home-based heart health programs result in higher satisfaction and better exercise habits among heart disease patients. These insights indicate that a personalized approach could significantly impact heart health management. ^{3 6 7 8 9}

Who Is on the Research Team?

Alexis Beatty, MD, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Adults aged 18+ who've been referred for cardiac rehab due to conditions like heart attack, surgery, or chronic heart failure and can communicate in English, Spanish, or Cantonese. Those in hospice or deemed unsuitable by their provider cannot join.

Inclusion Criteria

I am 18 years old or older.

I am referred for cardiac rehab due to a heart condition like a heart attack or surgery.

I can communicate in English, Spanish, or Cantonese.

Exclusion Criteria

Currently enrolled in hospice

My doctor has decided I should not join this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week tailored cardiac rehabilitation program with group and individual sessions

12 weeks

Every other week group sessions and individual counseling

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Referral to an external cardiac rehabilitation program
• Tailored cardiac rehabilitation

Trial Overview The study compares a tailored cardiac rehabilitation program within a safety net setting against usual care referral to an external program to see which leads to better participation in cardiac rehab.

How Is the Trial Designed?

Group I: Tailored cardiac rehabilitation in a safety net setting Experimental Treatment 1 Intervention

A 12-week program of exercise training and health behavior counseling consisting of every other week group sessions (exercise and health behavior education) and every other week individual counseling sessions that address the cardiac rehabilitation core components.

Group II: Referral to an outside cardiac rehabilitation program Active Control 1 Intervention

Referral to a cardiac rehabilitation program outside of the safety net hospital setting.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

This work was made possible by residual class settlement funds in the matter of April Krueger v. Wyeth, Inc., Case No. 03-cv-2496 (US District Court, SD of CA)

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2995341/

The Effects of a Cardiac Rehabilitation Program Tailored ... This RCT showed that a tailored CR intervention designed for women improved global QOL. Improving QOL may positively influence adherence to healthy behaviors.

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.039010

Cardiovascular Health in Cardiac Rehabilitation Our study demonstrates the efficacy of CR in improving CVH but underscores the need for better blood glucose management.

3. jacc.org jacc.org/doi/10.1016/j.jacasi.2025.08.007

Long-Term Outcomes of Digital Cardiac Rehabilitation The HBCR and regular exercise decrease long-term heart issues among patients with CAD. The long-term outcomes of digital CR studies with ≥12 months of follow-up ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772374725004454

Long-Term Outcomes of Digital Cardiac Rehabilitation Several studies suggest that patients participating in home-based cardiac rehabilitation (HBCR) report higher satisfaction, better exercise adherence, and ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMc2403909

Cardiac Rehabilitation — Challenges and Advances In observational studies, ICR has been shown to be superior to cardiac rehabilitation in controlling cholesterol, blood pressure, and weight and in reducing ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK537196/

Cardiac Rehabilitation - StatPearls - NCBI Bookshelf Studies show that cardiac rehabilitation is safe, has a low risk of complications, and offers benefits such as improved cardiovascular function ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001289

Core Components of Cardiac Rehabilitation Programs Cardiac rehabilitation (CR) reduces mortality rates and improves the quality of life of patients with cardiovascular disease (CVD), and its use ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10964460/

Safety and long-term outcomes of remote cardiac ... The overall study quality was of low risk. Conclusions. RDCR can act as a safe alternative delivery mode of cardiac rehabilitation (CR). The low ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0147956322000978

Safety of home-based cardiac rehabilitation: A systematic ... Previous research has shown that HBCR programs are feasible and effective. However, there is a lack of evidence on safety issues in different cardiac ...