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

Trial Summary

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.

What data supports the effectiveness of the treatment Intensive Cardiac Rehabilitation for cardiovascular disease?

Research shows that both traditional and intensive cardiac rehabilitation programs help improve heart health in patients with cardiovascular disease. Intensive programs like the Pritikin and Ornish programs have been shown to significantly improve heart risk factors and maintain these improvements over time. ^{1 2 3 4 5}

Is Intensive Cardiac Rehabilitation safe for humans?

Intensive Cardiac Rehabilitation (ICR) programs, like the Dr. Ornish Program and the Pritikin Program, are generally safe for humans and have been shown to improve heart health and reduce risk factors in patients with heart disease. These programs are medically supervised and covered by Medicare, indicating a recognized level of safety and effectiveness. ^{1 2 3 5 6}

How is Intensive Cardiac Rehabilitation different from Traditional Cardiac Rehabilitation for heart disease?

Intensive Cardiac Rehabilitation (ICR) is different from Traditional Cardiac Rehabilitation (TCR) because it includes more hours and focuses more on nutrition, stress management, and group support, rather than just exercise. This comprehensive approach aims to improve overall lifestyle and health, which can be particularly beneficial for heart disease patients. ^{1 2 5 6 7}

What is the purpose of this trial?

The goal of this prospective study is to evaluate whether the Intensive Cardiac Rehabilitation (ICR) program provides incremental benefits over the Traditional Cardiac Rehabilitation (TCR) program, defined by readmission costs. The study aims to confirm: * That ICR is associated with better outcomes than TCR, defined as lower readmission costs, lower incidence of major adverse cardiovascular events (MACE), and improvement in biomarkers, epigenetic markers, and inflammatory markers. * The addition of food to the ICR program will further improve these outcomes. ICR-eligible participants * Will be randomized into one of three groups: (1) ICR 72 session program with home-delivered C2life® supplied food, (2) ICR 72 session without C2life® supplied food, or (3) TCR 36 session program without C2life supplied food * Biometric measurements and laboratory measurements will be performed at entry into the rehab intervention, discharge from rehab intervention, and at 6 months after discharge. * Epigenetic measurements will be performed at admission and discharge from the rehab intervention

Research Team

David Beckner, MD

Principal Investigator

Ballad Health

Brian Asbill, MD

Principal Investigator

Mission Health

Frank A. Smith, MD

Principal Investigator

Trinity Health System

James R. Hebert, ScD, MSPH

Principal Investigator

Connecting Health Innovations, LLC (CHI)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Benefits of the First Pritikin Outpatient Intensive Cardiac Rehabilitation Program. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The effects of an intensive lifestyle modification program on carotid artery intima-media thickness: a randomized trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of lifestyle modification programs on cardiac risk factors. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Strategies for motivating CCU patients. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Physical and Psychological Outcomes of Patients Undergoing Traditional Cardiac Rehabilitation and Intensive Cardiac Rehabilitation. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Body Composition Changes During Traditional Versus Intensive Cardiac Rehabilitation in Coronary Artery Disease. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Intensive Cardiac Rehabilitation Is Markedly Underutilized by Medicare Beneficiaries: RESULTS FROM A 2012-2016 NATIONAL SAMPLE. [2023]