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Behavioural Intervention

Intensive vs Traditional Cardiac Rehabilitation for Cardiovascular Disease (CREDIBLE Trial)

N/A
Recruiting
Led By Brian Asbill, MD
Research Sponsored by Pritikin ICR
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up followup may extend up to 5 years for a post-hoc emr analysis.
Awards & highlights

Summary

This trial aims to compare the benefits of Intensive Cardiac Rehabilitation (ICR) versus Traditional Cardiac Rehabilitation (TCR) in terms of readmission costs and overall outcomes. Participants eligible for I

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves exercise programs and dietary changes rather than medication, side effects may include muscle soreness or fatigue from increased physical activity. Dietary changes could potentially cause digestive adjustments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~followup may extend up to 5 years for a post-hoc emr analysis.
This trial's timeline: 3 weeks for screening, Varies for treatment, and followup may extend up to 5 years for a post-hoc emr analysis. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Readmission Rate Data
Secondary outcome measures
Composite Total Readmission Rates
Dietary Inflammation Index (DII)
Epigenetic Biomarkers Performed by Prosper eDNA®
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: ICR-No FoodExperimental Treatment1 Intervention
Intensive Cardiac Rehab (ICR) 72-session program without C2life® supplied food
Group II: ICR-FoodExperimental Treatment2 Interventions
Intensive Cardiac Rehab (ICR_ 72-session program with C2life® supplied food
Group III: TCR-No FoodActive Control1 Intervention
Traditional Cardiac Rehab (TCR) 36-session program without C2life® supplied food

Find a Location

Who is running the clinical trial?

Pritikin ICRLead Sponsor
Ballad HealthOTHER
2 Previous Clinical Trials
800 Total Patients Enrolled
Mission Health System, Asheville, NCOTHER
4 Previous Clinical Trials
960 Total Patients Enrolled
~300 spots leftby Jun 2026
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