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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.
Implement the ICR Program to determine if
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Rehabilitation | Experimental | people recruited for the trial will participate in the Intensive cardiac rehabilitation arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lifestyle modification | Behavioral | Participants will undergo an exercise program designed by AHH |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Lipid | Total cholesterol, ADH, LDL and triglycerides (mg/dl) | Baseline to program completion (9-18 weeks) |
| Body Mass Index | calculated from Height and weight. | Baseline to program completion (9-18 weeks) |
| Resting Blood Pressure | Systolic and Diastolic Blood Pressure (mmHg) | Baseline to program completion (9-18 weeks) |
| Hemoglobin A1c | measure in whole blood (normal 4.5-6.2 (%)) | Baseline to program completion (9-18 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Dartmouth Coop quality of Life Questionnaire | Self-Reported assessment of participant general health | Baseline to program completion (9-18 weeks) |
| Hospital Re-admission rate | Number of time patient is admitted to the hospital for cardiovascular related events. |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Leybi Ramirez Kelly | Arkansas Heart Hospital/Arkansas Site Management Services LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Heart Hospital-Clinic | Little Rock | Arkansas | 72211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10824363 | Background | Bethell HJ. Cardiac rehabilitation: from Hellerstein to the millennium. Int J Clin Pract. 2000 Mar;54(2):92-7. | |
| Background | 3. Cardiac Rehabilitation Updated: Oct 31, 2018 Author: Vibhuti N Singh, MD, MPH, FACC, FSCAI; Chief Editor: Consuelo T Lorenzo, MD | ||
| 25490202 |
| Label | URL |
|---|---|
| Equipment used | View source |
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Data will not be share with other investigators outside of the research facility unless is for data analysis and publication
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Groups will be assigned to the exercise treatment group
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| Baseline to program completion (9-18 weeks) |
| Patient Health Questionnaire (PHQ9) | Assessment of perceive depression state. | Baseline to program completion (9-18 weeks) |
| Duke Activity Index | Assessment of physical Activity | Baseline to program completion (9-18 weeks) |
| 6-minute walk test | Distance walked in 6 minutes (mts) | Baseline and at program completion (9-18 weeks) |
| Medication Changes | decrease medications intake.. | Baseline to program completion (9-18 weeks) |
| Perceived Exertion (RPE) | as perceived by patient in the Rating of perceived Exertion scale. | Baseline to program completion (9-18 weeks) |
| Resting Metabolic Rate | measure in Kcal using the Mifflin-St. Jeor equation. | Baseline to program completion (9-18 weeks) |
| Diet intake | food records using the Passio App. | Baseline to program completion (9-18 weeks) |
| Background |
| Razavi M, Fournier S, Shepard DS, Ritter G, Strickler GK, Stason WB. Effects of lifestyle modification programs on cardiac risk factors. PLoS One. 2014 Dec 9;9(12):e114772. doi: 10.1371/journal.pone.0114772. eCollection 2014. |
| 11991917 | Background | Hill J, Timmis A. Exercise tolerance testing. BMJ. 2002 May 4;324(7345):1084-7. doi: 10.1136/bmj.324.7345.1084. No abstract available. |
| 9624662 | Background | American College of Sports Medicine Position Stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 1998 Jun;30(6):992-1008. |
| 23851406 | Background | Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available. |
| 8595435 | Background | Wenger NK, Froelicher ES, Smith LK, Ades PA, Berra K, Blumenthal JA, Certo CM, Dattilo AM, Davis D, DeBusk RF, et al. Cardiac rehabilitation as secondary prevention. Agency for Health Care Policy and Research and National Heart, Lung, and Blood Institute. Clin Pract Guidel Quick Ref Guide Clin. 1995 Oct;(17):1-23. |
| 19628486 | Background | Kothmann E, Batterham AM, Owen SJ, Turley AJ, Cheesman M, Parry A, Danjoux G. Effect of short-term exercise training on aerobic fitness in patients with abdominal aortic aneurysms: a pilot study. Br J Anaesth. 2009 Oct;103(4):505-10. doi: 10.1093/bja/aep205. Epub 2009 Jul 23. |
| 21385466 | Background | Rosenfeldt F, Braun L, Spitzer O, Bradley S, Shepherd J, Bailey M, van der Merwe J, Leong JY, Esmore D. Physical conditioning and mental stress reduction--a randomised trial in patients undergoing cardiac surgery. BMC Complement Altern Med. 2011 Mar 9;11:20. doi: 10.1186/1472-6882-11-20. |
| 24459173 | Background | Sawatzky JA, Kehler DS, Ready AE, Lerner N, Boreskie S, Lamont D, Luchik D, Arora RC, Duhamel TA. Prehabilitation program for elective coronary artery bypass graft surgery patients: a pilot randomized controlled study. Clin Rehabil. 2014 Jul;28(7):648-57. doi: 10.1177/0269215513516475. Epub 2014 Jan 23. |
| 16713353 | Background | Hadj A, Esmore D, Rowland M, Pepe S, Schneider L, Lewin J, Rosenfeldt F. Pre-operative preparation for cardiac surgery utilising a combination of metabolic, physical and mental therapy. Heart Lung Circ. 2006 Jun;15(3):172-81. doi: 10.1016/j.hlc.2006.01.008. Epub 2006 May 19. |