Effects of 9-18 Weeks of Intensive Cardiac Rehabilitation After a Major Cardiovascular Event in Patients With CVD (AHH-ICR)

January 23, 2023 updated by: Arkansas Heart Hospital

Effects of 9-18 Weeks of Intensive Cardiac Rehabilitation After a Major Cardiovascular Event in Patients With Cardiovascular Disease-AHH-ICR

Implement an intensive cardiac rehabilitation program at Arkansas Heart Hospital (AHH) to find out if the AHH-ICR is equivalent to the CMS approved programs when it comes to results.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Implement the ICR Program to determine if

  1. AHH-ICR will increase patients physical and psychological well-being and is non-superior/comparable to current ICR programs.
  2. To determine the most appropriate ICR program protocols to improve fitness and decrease cardiovascular risk factors.
  3. To determine if the ICR program has a direct relationship to improvements in the health of cardiovascular patients.
  4. To determine non-inferiority to already established ICR programs in the United States.

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital-Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Eligible for cardiac rehab per CMS requirements.
  2. Males and Females Age ≥ 65≤ 85 years
  3. Acute myocardial infarction within the preceding 6 months
  4. Coronary artery bypass surgery
  5. Current stable angina pectoris (chest pain)
  6. Heart valve repair or replacement
  7. Percutaneous transluminal coronary angioplasty or coronary stenting
  8. BMI ≥ 18 ≤35
  9. HgA1C ≤10

Exclusion Criteria:

- 1. Renal or hepatic dysfunction 2. Amputees (unless both groups have similar patients) 3. Current chemo/radiation treatment (unless both groups have similar patients) 4. Malnutrition 5. HIV/AIDS 6. Post-Bariatric surgery patients 7. History of substance abuse 8. Gastroparesis 9. Patients taking Warfarin/Coumadin 10. CHF patients on fluid restrictions requiring monitoring of water intake from food and liquids.

11. Cognitive deficits that would preclude cardiac rehabilitation 12. Patients with physical limitations that would prevent cardiac rehabilitation 13. Patients who are unable to attend the program 14. Patient who live >45… miles from cardiac rehab center

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cardiac Rehabilitation
people recruited for the trial will participate in the Intensive cardiac rehabilitation arm.
Behavioral: lifestyle modification
Participants will undergo an exercise program designed by AHH
Other Names:
  • exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Lipid
Time Frame: Baseline to program completion (9-18 weeks)
Total cholesterol, ADH, LDL and triglycerides (mg/dl)
Baseline to program completion (9-18 weeks)
Body Mass Index
Time Frame: Baseline to program completion (9-18 weeks)
calculated from Height and weight.
Baseline to program completion (9-18 weeks)
Resting Blood Pressure
Time Frame: Baseline to program completion (9-18 weeks)
Systolic and Diastolic Blood Pressure (mmHg)
Baseline to program completion (9-18 weeks)
Hemoglobin A1c
Time Frame: Baseline to program completion (9-18 weeks)
measure in whole blood (normal 4.5-6.2 (%))
Baseline to program completion (9-18 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dartmouth Coop quality of Life Questionnaire
Time Frame: Baseline to program completion (9-18 weeks)
Self-Reported assessment of participant general health
Baseline to program completion (9-18 weeks)
Hospital Re-admission rate
Time Frame: Baseline to program completion (9-18 weeks)
Number of time patient is admitted to the hospital for cardiovascular related events.
Baseline to program completion (9-18 weeks)
Patient Health Questionnaire (PHQ9)
Time Frame: Baseline to program completion (9-18 weeks)
Assessment of perceive depression state.
Baseline to program completion (9-18 weeks)
Duke Activity Index
Time Frame: Baseline to program completion (9-18 weeks)
Assessment of physical Activity
Baseline to program completion (9-18 weeks)
6-minute walk test
Time Frame: Baseline and at program completion (9-18 weeks)
Distance walked in 6 minutes (mts)
Baseline and at program completion (9-18 weeks)
Medication Changes
Time Frame: Baseline to program completion (9-18 weeks)
decrease medications intake..
Baseline to program completion (9-18 weeks)
Perceived Exertion (RPE)
Time Frame: Baseline to program completion (9-18 weeks)
as perceived by patient in the Rating of perceived Exertion scale.
Baseline to program completion (9-18 weeks)
Resting Metabolic Rate
Time Frame: Baseline to program completion (9-18 weeks)
measure in Kcal using the Mifflin-St. Jeor equation.
Baseline to program completion (9-18 weeks)
Diet intake
Time Frame: Baseline to program completion (9-18 weeks)
food records using the Passio App.
Baseline to program completion (9-18 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Heart Hospital

Investigators

  • Study Director: Leybi Ramirez Kelly, Arkansas Heart Hospital/Arkansas Site Management Services LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 20, 2019

Primary Completion (ACTUAL)

June 27, 2021

Study Completion (ACTUAL)

June 27, 2021

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (ACTUAL)

February 1, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHH-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be share with other investigators outside of the research facility unless is for data analysis and publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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