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Completed

NCT Number: NCT05708313

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

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.

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Key information

Conditions

Cardiovascular Diseases Behavior Lifestyle Risk Reduction Risk Reduction Behavior

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Heart Hospital-Clinic

Little Rock, Arkansas, 72211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

Lifestyle Modification

Behavioral

Participants will undergo an exercise program designed by AHH

Other names: exercise

Primary outcomes

  1. Serum Lipid

    Time frame: Baseline to program completion (9-18 weeks)

    Total cholesterol, ADH, LDL and triglycerides (mg/dl)

  2. Body Mass Index

    Time frame: Baseline to program completion (9-18 weeks)

    calculated from Height and weight.

  3. Resting Blood Pressure

    Time frame: Baseline to program completion (9-18 weeks)

    Systolic and Diastolic Blood Pressure (mmHg)

  4. Hemoglobin A1c

    Time frame: Baseline to program completion (9-18 weeks)

    measure in whole blood (normal 4.5-6.2 (%))

Secondary outcomes

  1. Dartmouth Coop quality of Life Questionnaire

    Time frame: Baseline to program completion (9-18 weeks)

    Self-Reported assessment of participant general health

  2. Hospital Re-admission rate

    Time frame: Baseline to program completion (9-18 weeks)

    Number of time patient is admitted to the hospital for cardiovascular related events.

  3. Patient Health Questionnaire (PHQ9)

    Time frame: Baseline to program completion (9-18 weeks)

    Assessment of perceive depression state.

  4. Duke Activity Index

    Time frame: Baseline to program completion (9-18 weeks)

    Assessment of physical Activity

  5. 6-minute walk test

    Time frame: Baseline and at program completion (9-18 weeks)

    Distance walked in 6 minutes (mts)

  6. Medication Changes

    Time frame: Baseline to program completion (9-18 weeks)

    decrease medications intake..

  7. Perceived Exertion (RPE)

    Time frame: Baseline to program completion (9-18 weeks)

    as perceived by patient in the Rating of perceived Exertion scale.

  8. Resting Metabolic Rate

    Time frame: Baseline to program completion (9-18 weeks)

    measure in Kcal using the Mifflin-St. Jeor equation.

  9. Diet intake

    Time frame: Baseline to program completion (9-18 weeks)

    food records using the Passio App.

Sponsors and collaborators

Lead sponsor

Arkansas Heart Hospital

Other

Registry information

Official study title

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

Acronym: AHH-ICR

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 1, 2023
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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