Effects of 9-18 Weeks of Intensive Cardiac Rehabilitation After a Major Cardiovascular Event in Patients With CVD
- Conditions
- Lifestyle Risk ReductionCardiovascular Diseases
- Interventions
- Behavioral: lifestyle modification
- Registration Number
- NCT05708313
- Lead Sponsor
- Arkansas Heart Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198
- 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
-
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cardiac Rehabilitation lifestyle modification people recruited for the trial will participate in the Intensive cardiac rehabilitation arm.
- Primary Outcome Measures
Name Time Method Serum Lipid Baseline to program completion (9-18 weeks) Total cholesterol, ADH, LDL and triglycerides (mg/dl)
Body Mass Index Baseline to program completion (9-18 weeks) calculated from Height and weight.
Hemoglobin A1c Baseline to program completion (9-18 weeks) measure in whole blood (normal 4.5-6.2 (%))
Resting Blood Pressure Baseline to program completion (9-18 weeks) Systolic and Diastolic Blood Pressure (mmHg)
- Secondary Outcome Measures
Name Time Method Diet intake Baseline to program completion (9-18 weeks) food records using the Passio App.
Perceived Exertion (RPE) Baseline to program completion (9-18 weeks) as perceived by patient in the Rating of perceived Exertion scale.
Hospital Re-admission rate Baseline to program completion (9-18 weeks) Number of time patient is admitted to the hospital for cardiovascular related events.
Duke Activity Index Baseline to program completion (9-18 weeks) Assessment of physical Activity
Dartmouth Coop quality of Life Questionnaire Baseline to program completion (9-18 weeks) Self-Reported assessment of participant general health
Patient Health Questionnaire (PHQ9) Baseline to program completion (9-18 weeks) Assessment of perceive depression state.
6-minute walk test Baseline and at program completion (9-18 weeks) Distance walked in 6 minutes (mts)
Resting Metabolic Rate Baseline to program completion (9-18 weeks) measure in Kcal using the Mifflin-St. Jeor equation.
Medication Changes Baseline to program completion (9-18 weeks) decrease medications intake..
Trial Locations
- Locations (1)
Arkansas Heart Hospital-Clinic
🇺🇸Little Rock, Arkansas, United States