Intensive Cardiac Rehabilitation (ICR): Tolerability and Effectiveness

NCT02987049 | Completed

• 1 other identifier: 201611030
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiac Disease

Keywords

heart disease, cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dietary Intake

  Baseline and Vist 24, which occurs between 8 and 12 weeks

• Body Composition

  Baseline and Vist 24, which occurs between 8 and 12 weeks

Other Outcomes (13)

• Hand Grip Strength

  Baseline and Vist 24, which occurs between 8 and 12 weeks

• Short Physical Performance Battery (SPBB)

  Baseline and Vist 24, which occurs between 8 and 12 weeks

• Serum Lipid Concentrations

  Baseline and Vist 24, which occurs between 8 and 12 weeks

Study Arms (2)

ICR (Intensive Cardiac Rehab)

The Intensive Cardiac Rehabilitation (ICR) group will follow their physician-prescribed series of supervised exercise sessions and educational sessions in a cardiac rehab facility. The education component includes a series of Pritikin videos, nutrition workshops and cooking classes led by a registered dietitian, one-on-one dietary consultation with a registered dietitian, and a Pritikin notebook. The intervention for this study is comprised of 24 exercise sessions plus 24 educational sessions in 24 visits.

CR (conventional Cardiac Rehab)

The conventional Cardiac Rehabilitation (CR) group will follow their physician-prescribed series of supervised exercise sessions in the same cardiac rehab facility as the ICR group. The intervention for this study is comprised of 24 exercise sessions during 24 visits.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients who are at least 18 years of age and are referred to the BJC/Washington University School of Medicine Cardiac Rehab program at the Heart Care Institute in St. Louis, MO will be invited to participate in this study.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related 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.

  PMID: 1787805 BACKGROUND

• 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.

  PMID: 3966484 BACKGROUND

• 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.

  PMID: 12427646 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be obtained and the serum or plasma will be stored for future quantification of inflammatory cytokines and other factors related to cardiovascular disease risk.

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Linda R Peterson, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: December 8, 2016
• Study Start: January 9, 2017
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05