Clinical trial NCT05708313: Effects of 9-18 Weeks of Intensive Cardiac Rehabilitation After a Major Cardiovascular Event in Patients With CVD
Official title: Effects of 9-18 Weeks of Intensive Cardiac Rehabilitation After a Major Cardiovascular Event in Patients With Cardiovascular Disease-AHH-ICR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lifestyle Risk Reduction
Lead sponsor: Arkansas Heart Hospital
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 198
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Groups will be assigned to the exercise treatment group
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum Lipid
timeFrame: Baseline to program completion (9-18 weeks)
measure: Body Mass Index
timeFrame: Baseline to program completion (9-18 weeks)
measure: Resting Blood Pressure
timeFrame: Baseline to program completion (9-18 weeks)
measure: Hemoglobin A1c
timeFrame: Baseline to program completion (9-18 weeks)
Secondary outcomes:
measure: Dartmouth Coop quality of Life Questionnaire
timeFrame: Baseline to program completion (9-18 weeks)
measure: Hospital Re-admission rate
timeFrame: Baseline to program completion (9-18 weeks)
measure: Patient Health Questionnaire (PHQ9)
timeFrame: Baseline to program completion (9-18 weeks)
measure: Duke Activity Index
timeFrame: Baseline to program completion (9-18 weeks)
measure: 6-minute walk test
timeFrame: Baseline and at program completion (9-18 weeks)
measure: Medication Changes
timeFrame: Baseline to program completion (9-18 weeks)
measure: Perceived Exertion (RPE)
timeFrame: Baseline to program completion (9-18 weeks)
measure: Resting Metabolic Rate
timeFrame: Baseline to program completion (9-18 weeks)
measure: Diet intake
timeFrame: Baseline to program completion (9-18 weeks)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Heart Hospital-Clinic
state: Arkansas
Study officials:
affiliation: Arkansas Heart Hospital/Arkansas Site Management Services LLC
name: Leybi Ramirez Kelly
role: STUDY_DIRECTOR
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