Effects of 9-18 Weeks of Intensive Cardiac Rehabilitation After a Major Cardiovascular Event in Patients With Cardiovascular Disease-AHH-ICR
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Arkansas Heart Hospital
- Enrollment
- 198
- Locations
- 1
- Primary Endpoint
- Serum Lipid
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •Renal or hepatic dysfunction
- •Amputees (unless both groups have similar patients)
- •Current chemo/radiation treatment (unless both groups have similar patients)
- •Malnutrition
- •Post-Bariatric surgery patients
- •History of substance abuse
- •Gastroparesis
- •Patients taking Warfarin/Coumadin
- •CHF patients on fluid restrictions requiring monitoring of water intake from food and liquids.
- •Cognitive deficits that would preclude cardiac rehabilitation
Outcomes
Primary Outcomes
Serum Lipid
Time Frame: Baseline to program completion (9-18 weeks)
Total cholesterol, ADH, LDL and triglycerides (mg/dl)
Body Mass Index
Time Frame: Baseline to program completion (9-18 weeks)
calculated from Height and weight.
Hemoglobin A1c
Time Frame: Baseline to program completion (9-18 weeks)
measure in whole blood (normal 4.5-6.2 (%))
Resting Blood Pressure
Time Frame: Baseline to program completion (9-18 weeks)
Systolic and Diastolic Blood Pressure (mmHg)
Secondary Outcomes
- 6-minute walk test(Baseline and at program completion (9-18 weeks))
- Perceived Exertion (RPE)(Baseline to program completion (9-18 weeks))
- Hospital Re-admission rate(Baseline to program completion (9-18 weeks))
- Patient Health Questionnaire (PHQ9)(Baseline to program completion (9-18 weeks))
- Diet intake(Baseline to program completion (9-18 weeks))
- Duke Activity Index(Baseline to program completion (9-18 weeks))
- Dartmouth Coop quality of Life Questionnaire(Baseline to program completion (9-18 weeks))
- Resting Metabolic Rate(Baseline to program completion (9-18 weeks))
- Medication Changes(Baseline to program completion (9-18 weeks))