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

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Cardiovascular Diseases, Lifestyle Risk Reduction

Intervention / Treatment
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* Behavioral: lifestyle modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for cardiac rehab per CMS requirements. Males and Females Age ≥ 65≤ 85 years Acute myocardial infarction within the preceding 6 months Coronary artery bypass surgery Current stable angina pectoris (chest pain) Heart valve repair or replacement Percutaneous transluminal coronary angioplasty or coronary stenting BMI ≥ 18 ≤35 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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Groups will be assigned to the exercise treatment group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac Rehabilitation<br>people recruited for the trial will participate in the Intensive cardiac rehabilitation arm. | Behavioral: lifestyle modification<br>* Participants will undergo an exercise program designed by AHH<br>* Other names: exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Lipid | Total cholesterol, ADH, LDL and triglycerides (mg/dl) | Baseline to program completion (9-18 weeks) | 
| Body Mass Index | calculated from Height and weight. | Baseline to program completion (9-18 weeks) | 
| Resting Blood Pressure | Systolic and Diastolic Blood Pressure (mmHg) | Baseline to program completion (9-18 weeks) | 
| Hemoglobin A1c | 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 | Self-Reported assessment of participant general health | Baseline to program completion (9-18 weeks) | 
| Hospital Re-admission rate | Number of time patient is admitted to the hospital for cardiovascular related events. | Baseline to program completion (9-18 weeks) | 
| Patient Health Questionnaire (PHQ9) | Assessment of perceive depression state. | Baseline to program completion (9-18 weeks) | 
| Duke Activity Index | Assessment of physical Activity | Baseline to program completion (9-18 weeks) | 
| 6-minute walk test | Distance walked in 6 minutes (mts) | Baseline and at program completion (9-18 weeks) | 
| Medication Changes | decrease medications intake.. | Baseline to program completion (9-18 weeks) | 
| Perceived Exertion (RPE) | as perceived by patient in the Rating of perceived Exertion scale. | Baseline to program completion (9-18 weeks) | 
| Resting Metabolic Rate | measure in Kcal using the Mifflin-St. Jeor equation. | Baseline to program completion (9-18 weeks) | 
| Diet intake | food records using the Passio App. | Baseline to program completion (9-18 weeks) |