Intensive vs Traditional Cardiac Rehabilitation for Cardiovascular Disease

(CREDIBLE Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pritikin ICR

Disqualifiers: Life expectancy under 2 years, others

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

Compensation: Varies

Number of Visits: 78

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Intensive Cardiac Rehabilitation (ICR) surpasses Traditional Cardiac Rehabilitation (TCR) for individuals with heart disease. Researchers aim to determine if ICR can lower hospital readmission costs, reduce major heart problems, and improve health markers. Participants may also receive healthy food deliveries to assess whether this boosts the benefits of ICR. The trial seeks individuals who have recently experienced heart issues, such as a heart attack or heart surgery, and could benefit from a structured rehab program. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance cardiac care for future patients.

Do I need to stop my current medications for this 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Intensive Cardiac Rehabilitation (ICR) is generally safe for people with heart conditions, regardless of specific dietary components. Studies have found that participants tolerate ICR well, with no major problems reported.

In one study, patients who participated in the ICR program, which included personalized exercise sessions, experienced improvements in heart health without serious side effects. The program incorporates safe exercise routines, healthy eating, and stress management, all of which contribute to better heart health.

The program also includes C2life® foods to support a heart-healthy diet, and no evidence suggests these foods cause harm. Overall, research indicates that joining an ICR program is a safe way to enhance heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these cardiac rehabilitation methods because they offer a fresh approach to improving heart health for those with cardiovascular disease. Unlike traditional cardiac rehab, which typically involves a 36-session program, the intensive cardiac rehab (ICR) approach doubles the engagement with a 72-session program. This increased frequency could potentially lead to better long-term outcomes by keeping patients more engaged and active in their recovery. Additionally, one of the ICR options includes meals provided by C2life®, which aims to support patients nutritionally throughout their rehab, potentially enhancing the overall benefits of the program. These features may provide a more comprehensive and supportive recovery experience compared to standard care.

What evidence suggests that this trial's treatments could be effective for cardiovascular disease?

This trial will compare Intensive Cardiac Rehabilitation (ICR) with Traditional Cardiac Rehabilitation (TCR). Research has shown that ICR can be more effective for heart health than TCR. Specifically, studies have found that ICR programs, such as the Ornish and Pritikin programs, greatly reduce risk factors for heart disease and improve heart health. For instance, patients in these programs experienced fewer major heart problems, like heart attacks, and showed better health improvements. In this trial, some participants will receive ICR with a nutrition component, such as C2life® food, which may further enhance these benefits. Overall, evidence suggests that ICR could lead to better heart health compared to traditional methods. ^{1 3 4 5 6}

Who Is on the Research Team?

Brian Asbill, MD

Principal Investigator

Mission Health

David Beckner, MD

Principal Investigator

Ballad Health

Frank A. Smith, MD

Principal Investigator

Trinity Health System

James R. Hebert, ScD, MSPH

Principal Investigator

Connecting Health Innovations, LLC (CHI)

Are You a Good Fit for This Trial?

This trial is for individuals with cardiovascular disease who are eligible for cardiac rehabilitation. Participants will be randomly assigned to one of three groups: an intensive rehab program with special food delivery, the same without food, or a traditional rehab program.

Inclusion Criteria

All patients eligible for an Intensive Cardiac Rehabilitation (ICR) Program at each of the three study sites

I have had a heart event like a heart attack or surgery, and my heart pumps less effectively.

Exclusion Criteria

Anticipated life expectancy of under 2 years

Any co-morbidity that would limit participation in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Rehabilitation Intervention

Participants undergo either Intensive Cardiac Rehabilitation (ICR) or Traditional Cardiac Rehabilitation (TCR) with biometric and laboratory measurements at entry and discharge.

12 weeks

72 sessions for ICR, 36 sessions for TCR

Follow-up

Participants are monitored for safety and effectiveness after treatment, with measurements at 6 months post-discharge.

6 months

Measurements at 6 months post-discharge

Long-term Follow-up

Post-hoc EMR analysis for readmission rates and MACE up to 5 years.

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Intensive Cardiac Rehabilitation
• Traditional Cardiac Rehabilitation

Trial Overview The study compares outcomes between Intensive Cardiac Rehabilitation (ICR) and Traditional Cardiac Rehabilitation (TCR). It looks at readmission costs, major adverse cardiovascular events, and changes in biomarkers. The effect of adding C2life® Food to ICR is also being tested.

How Is the Trial Designed?

Group I: ICR-No Food Experimental Treatment 1 Intervention

Intensive Cardiac Rehab (ICR) 72-session program without C2life® supplied food

Group II: ICR-Food Experimental Treatment 2 Interventions

Intensive Cardiac Rehab (ICR\_ 72-session program with C2life® supplied food

Group III: TCR-No Food Active Control 1 Intervention

Traditional Cardiac Rehab (TCR) 36-session program without C2life® supplied food

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

Approved in United States as Intensive Cardiac Rehabilitation for:

• Acute myocardial infarction
• Coronary bypass surgery
• Stable angina pectoris
• Heart valve repair or replacement
• Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting
• Heart or heart-lung transplant

Approved in European Union as Intensive Cardiac Rehabilitation for:

• Myocardial infarction
• Coronary artery bypass grafting
• Stable angina
• Heart failure
• Valvular surgery
• Cardiac transplantation

Approved in Canada as Intensive Cardiac Rehabilitation for:

• Recent myocardial infarction
• Acute coronary artery syndrome
• Chronic stable angina
• Congestive heart failure
• After coronary artery bypass surgery
• After a percutaneous coronary intervention
• Valvular surgery
• Cardiac transplantation

Who Is Running the Clinical Trial?

Pritikin ICR

Lead Sponsor

Trials

1

Recruited

450+

Ballad Health

Collaborator

Trials

4

Recruited

1,300+

Mission Health System, Asheville, NC

Collaborator

Trials

5

Recruited

1,400+

Trinity Health

Collaborator

Trials

2

Recruited

1,400+

Connecting Health Innovation

Collaborator

Trials

2

Recruited

470+

Trinity Health System

Industry Sponsor

Trials

4

Recruited

1,500+

Published Research Related to This Trial

A study involving 580 participants with coronary artery disease showed that both the Ornish and Benson-Henry lifestyle modification programs significantly improved cardiac risk factors during a 3-month intervention, with many participants maintaining these improvements for up to 24 months.

Motivation to lose weight was a key factor in sustaining weight loss, highlighting the importance of psychological support in lifestyle interventions for heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of lifestyle modification programs on cardiac risk factors. Razavi, M., Fournier, S., Shepard, DS., et al.[2020]

Intensive cardiac rehabilitation (ICR) is significantly underutilized, with only 0.1% of eligible Medicare patients participating from 2012 to 2016, despite its Medicare approval and the increase in ICR centers from 15 to 50 during this period.

While both ICR and traditional cardiac rehabilitation (CR) have shown effectiveness in treating cardiovascular disease, participation rates for CR were higher at 16.2%, indicating a need for further research to identify barriers to ICR utilization among eligible patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive Cardiac Rehabilitation Is Markedly Underutilized by Medicare Beneficiaries: RESULTS FROM A 2012-2016 NATIONAL SAMPLE. Husaini, M., Deych, E., Racette, SB., et al.[2023]

The Pritikin outpatient intensive cardiac rehabilitation (ICR) program significantly improved various cardiovascular health measures, including weight, dietary patterns, physical function, and health-related quality of life, in a study of 1963 patients, with 1141 completing the program.

Patients in the ICR group showed greater improvements in anthropometric measures and dietary habits compared to those in traditional cardiac rehabilitation, suggesting that the comprehensive approach of ICR may offer enhanced benefits for cardiac health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of the First Pritikin Outpatient Intensive Cardiac Rehabilitation Program. Racette, SB., Park, LK., Rashdi, ST., et al.[2023]

In a study of 970 patients with cardiovascular disease, traditional cardiac rehabilitation (TCR) led to greater improvements in cardiorespiratory fitness compared to intensive cardiac rehabilitation (ICR), with TCR participants showing a mean increase of +1.9 METs versus +1.5 METs in ICR.

Conversely, patients undergoing ICR experienced significantly greater reductions in anxiety and depression scores, indicating that while TCR may enhance physical fitness, ICR may be more effective for improving mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and Psychological Outcomes of Patients Undergoing Traditional Cardiac Rehabilitation and Intensive Cardiac Rehabilitation. Jafri, SH., Duazo, C., Imran, H., et al.[2023]

Critical care nurses play a vital role in motivating cardiac patients to engage in rehabilitation programs while they are still in critical or intermediate care, addressing the need for early intervention due to shorter hospital stays.

The involvement of critical care nurses in rehabilitation can enhance patient outcomes by encouraging participation in cardiac rehabilitation, which is essential for recovery after serious cardiac events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for motivating CCU patients. Jairath, N.[2019]

In a study of 715 patients with coronary artery disease, both intensive and traditional cardiac rehabilitation programs significantly improved cardiovascular risk factors, including reductions in body mass index, body fat percentage, blood pressure, and cholesterol levels.

Patients in the intensive cardiac rehabilitation program experienced greater improvements in body composition and diastolic blood pressure compared to those in the traditional program, suggesting that a more comprehensive approach may yield better results in certain areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body Composition Changes During Traditional Versus Intensive Cardiac Rehabilitation in Coronary Artery Disease. Mirman, AM., Nardoni, NR., Chen, AY., et al.[2021]

The Dr. Dean Ornish Program for Reversing Heart Disease did not significantly reduce the thickness of the carotid artery in patients with coronary artery disease, indicating it may not alter the atherosclerotic process.

Participants in the Ornish Program showed significant improvements in dietary habits, weight, and body mass index, along with a 44% reduction in angina symptoms over 12 months, compared to only a 12% reduction in the traditional cardiac rehabilitation group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of an intensive lifestyle modification program on carotid artery intima-media thickness: a randomized trial. Aldana, SG., Greenlaw, R., Salberg, A., et al.[2022]

Citations

1. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=240&NcaName=Intensive+Cardiac+Rehabilitation+%28ICR%29+Program+-+Dr.+Ornish

NCA - Intensive Cardiac Rehabilitation (ICR) Program - Dr. ... Use this page to view details for the decision Memo for Intensive Cardiac Rehabilitation (ICR) Program - Dr. Ornish's Program for Reversing Heart Disease ...

2. aetna.com aetna.com/cpb/medical/data/200_299/0267.html

Intensive Cardiac Rehabilitation Programs In a randomized study, Aldana and colleagues (2007) evaluated the effect of the Ornish Program for Reversing Heart Disease on cardiovascular disease as measured ...

3. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=271

Benson-Henry Institute Cardiac Wellness Program (CAG ... The evidence is sufficient to expand the intensive cardiac rehabilitation (ICR) benefit to include the Benson-Henry Institute Cardiac Wellness Program.

4. uclahealth.org uclahealth.org/sites/default/files/documents/Ornish_LiteratureReview.pdf?f=90b7156a

Scientifically Proven Research for the Dr. Dean Ornish ... The purpose of this study is to test the efficacy and effectives of an intensive cardiac rehabilitation program in improving health outcomes in multiple sites.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9643589/

Benefits of the First Pritikin Outpatient Intensive Cardiac ... The Pritikin outpatient ICR program promoted improvements in several cardiovascular health indices. Critical next steps are to assess long-term ...

6. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&ncaid=240

NCA - Intensive Cardiac Rehabilitation (ICR) Program The Multisite Cardiac Lifestyle Intervention Program consisted of individually prescribed exercise for a minimum of 3 hours per week for a minimum of 30 minutes ...