Cardiovascular Diseases, Lifestyle Risk Reduction
Conditions
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.
Interventions
BEHAVIORALlifestyle modification
Participants will undergo an exercise program designed by AHH
Sponsors
Arkansas Heart Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Groups will be assigned to the exercise treatment group
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Resting Blood Pressure | Baseline to program completion (9-18 weeks) | Systolic and Diastolic Blood Pressure (mmHg) |
| Hemoglobin A1c | Baseline to program completion (9-18 weeks) | measure in whole blood (normal 4.5-6.2 (%)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk test | Baseline and at program completion (9-18 weeks) | Distance walked in 6 minutes (mts) |
| Medication Changes | Baseline to program completion (9-18 weeks) | decrease medications intake.. |
| Dartmouth Coop quality of Life Questionnaire | Baseline to program completion (9-18 weeks) | Self-Reported assessment of participant general health |
| Resting Metabolic Rate | Baseline to program completion (9-18 weeks) | measure in Kcal using the Mifflin-St. Jeor equation. |
| 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. |
| Patient Health Questionnaire (PHQ9) | Baseline to program completion (9-18 weeks) | Assessment of perceive depression state. |
| Duke Activity Index | Baseline to program completion (9-18 weeks) | Assessment of physical Activity |
Countries
United States
Outcome results
None listed