Intensive Cardiac Rehabilitation (ICR): Tolerability and Effectiveness

Cardiac Disease Clinical Trial

Official title:

Intensive Cardiac Rehabilitation (ICR) With the Pritikin Program: Tolerability and Effectiveness

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02987049
• Other study ID #: 201611030
• Status: Enrolling by invitation
• Start date: January 9, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to fill in the gaps in knowledge on the tolerability and effectiveness of an outpatient, Pritikin-based Intensive Cardiac Rehabilitation (ICR) program on traditional cardiovascular risk factors, exercise performance, and patient well-being (as assessed by questionnaires), as well as to monitor subsequent clinical events. The hypothesis is that patients in the Intensive Cardiac Rehabilitation (ICR) group will have greater improvements in several cardiovascular disease risk factors than patients in the conventional Cardiac Rehabilitation (CR) group at the end of 24 sessions.

Description:

BACKGROUND: Conventional Cardiac Rehabilitation (CR) involves a 36-session supervised and monitored exercise treatment program in a cardiac rehabilitation facility for patients with an approved cardiac diagnosis, such as chronic angina, recent myocardial infarction (heart attack), cardiac surgery, or recent percutaneous coronary intervention. The exercise sessions generally are one hour each and the treatment period is typically over 12 weeks. Intensive Cardiac Rehabilitation (ICR) includes the 36-session exercise intervention plus 36 one-hour educational sessions on the Pritikin program. These education sessions include one-on-one dietary consultation with a registered dietitian, nutrition workshops and cooking classes led by a registered dietitian, a series of Pritikin videos, and a notebook of Pritikin handouts on various topics, including reading nutrition labels, how to prepare heart-healthy meals, mindfulness, smoking cessation, and the process of atherosclerosis.

Nathan Pritikin started the Pritikin program in the 1970s with the aim of decreasing recurrent cardiovascular disease (CVD) events in humans. The three pillars of the Pritikin lifestyle program are a healthy diet, exercise, and mindfulness. The Pritikin diet emphasizes unprocessed foods that are high in fiber, low in calorie density, and very low in sodium, saturated fat, and cholesterol. Mindfulness includes behavior modification therapies such as smoking cessation and stress management. Since the 1970s, there have been more than 100 publications in scientific, peer-reviewed journals demonstrating the efficacy of this program on improving many traditional cardiac risk factors and biomarkers of cardiac health, as well as preventing and treating CVD. In addition, a low-fat, high fiber diet combined with exercise has been shown to improve markers of nitric oxide bioavailability and fasting insulin concentrations.

Most of these results, however, were derived from studies of patients domiciled at a Pritikin wellness center. Relatively recently, the Pritikin program was approved as a form of ICR in an outpatient setting. The BJC/Washington University School of Medicine Cardiac Rehab program at the Heart Care Institute was the first Cardiac Rehab program in the world to offer an outpatient Pritikin ICR program. Currently, Medicare and some (but not all) third-party insurance companies pay for ICR. Thus, many patients under the age of 65 years are not afforded the potential benefits of ICR.

SPECIFIC AIM: The purpose of this study is to fill in the gaps in knowledge on the tolerability and effectiveness of an outpatient, Pritikin-based ICR program on traditional cardiovascular risk factors, exercise performance, and patient well-being (as assessed by questionnaires), as well as to monitor subsequent clinical events in this outpatient population.

HYPOTHESIS: The hypothesis is that patients in the Intensive Cardiac Rehabilitation (ICR) group will have greater improvements in several cardiovascular risk factors than patients in the conventional Cardiac Rehab (CR) group at the end of 24 sessions.

FUTURE DIRECTIONS: If the results of this study are favorable, then there are several implications for clinical practice. 1) Evidence of the effectiveness and tolerability of outpatient ICR should encourage expanded coverage of ICR so that more cardiac patients may benefit from this treatment in the future. 2) Demonstration of any trends in improvement of outcomes would support the need for a multi-center trial to define the degree to which ICR can help patients and decrease health care-related costs. These questions would be explored in future R34 grants and Patient-Centered Outcomes Research Institute (PCORI) grants.

STUDY OVERVIEW: This is a 2-year, non-randomized study in which the Intensive Cardiac Rehab (ICR) and conventional Cardiac Rehab (CR) treatment programs are already being conducted as part of routine clinical care in a cardiac rehabilitation facility. Many of the assessments to be conducted and the outcome measures of this study are being obtained as part of the existing cardiac rehab programs. Assignment to the ICR or CR group will be according to the referring physician's recommendation and insurance coverage and will occur before study enrollment. The research portion is obtaining permission to include the participants' phenotypic and outcome data in the research study database and analyzing the information in a systematic manner to answer study questions regarding the tolerability and effectiveness of the ICR program. Participants also will be asked to complete additional assessments and questionnaires that are for research purposes only.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• individuals with a cardiac diagnosis or procedure who are referred to the BJC HealthCare / Washington University School of Medicine Cardiac Rehab program at the Heart Care Institute in St. Louis, Missouri

• individuals who are ambulatory

Exclusion Criteria:

• individuals with other significant medical conditions that preclude exercise or that would interfere with the assessments involved in this study

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

References & Publications (3)

Martin W. Nathan Pritikin and atheroma. Med Hypotheses. 1991 Nov;36(3):181-2. doi: 10.1016/0306-9877(91)90125-i. No abstract available. — View Citation

Roberts CK, Vaziri ND, Barnard RJ. Effect of diet and exercise intervention on blood pressure, insulin, oxidative stress, and nitric oxide availability. Circulation. 2002 Nov 12;106(20):2530-2. doi: 10.1161/01.cir.0000040584.91836.0d. — View Citation

Rosenthal MB, Barnard RJ, Rose DP, Inkeles S, Hall J, Pritikin N. Effects of a high-complex-carbohydrate, low-fat, low-cholesterol diet on levels of serum lipids and estradiol. Am J Med. 1985 Jan;78(1):23-7. doi: 10.1016/0002-9343(85)90456-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hand Grip Strength	Quantified with a Jamar Plus hand dynamometer	Baseline and Vist 24, which occurs between 8 and 12 weeks
Other	Short Physical Performance Battery (SPBB)	3 tests: 4m walk, balance, chair rise	Baseline and Vist 24, which occurs between 8 and 12 weeks
Other	Serum Lipid Concentrations	Total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides	Baseline and Vist 24, which occurs between 8 and 12 weeks
Other	Hemoglobin A1c	quantified in whole blood	Baseline and Vist 24, which occurs between 8 and 12 weeks
Other	Resting Blood Pressure	systolic BP and diastolic BP (mmHg)	Baseline and Vist 24, which occurs between 8 and 12 weeks
Other	Resting Heart Rate	bpm	Baseline and Vist 24, which occurs between 8 and 12 weeks
Other	Duke Activity Status Index (DASI) Questionnaire	Self-reported physical activity assessment	Baseline and Vist 24, which occurs between 8 and 12 weeks
Other	Dartmouth Coop General Health Questionnaire	Self-reported general health	Baseline and Vist 24, which occurs between 8 and 12 weeks
Other	Cardiac Self-Efficacy Questionnaire	Sullivan CSE	Baseline and Vist 24, which occurs between 8 and 12 weeks
Other	Patient Health Questionnaire-9 (PHQ-9)	Depression assessment	Baseline and Vist 24, which occurs between 8 and 12 weeks
Other	6-Minute Walk	Distance walked in 6 minutes	Baseline and Vist 24, which occurs between 8 and 12 weeks
Other	Arterial Function	Endothelial vasodilator function (i.e., arterial function) will be assessed using an EndoPat device	Baseline and Vist 24, which occurs between 8 and 12 weeks
Other	Medication Changes	Medication changes from Baseline to Visit 24	Baseline and Vist 24, which occurs between 8 and 12 weeks
Primary	Body Mass Index (BMI)	BMI will be computed from measured height and weight	Baseline and Vist 24, which occurs between 8 and 12 weeks
Secondary	Dietary Intake	Diet will be assessed using the Rate Your Plate questionnaire	Baseline and Vist 24, which occurs between 8 and 12 weeks
Secondary	Body Composition	% body fat, fat mass (kg), and fat-free mass (FFM) will be assessed by bioelectrical impedance analysis	Baseline and Vist 24, which occurs between 8 and 12 weeks