Effects of 9-18 Weeks of Intensive Cardiac Rehabilitation After a Major Cardiovascular Event in Patients With CVD
NCT ID: NCT05708313
Last Updated: 2023-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
198 participants
INTERVENTIONAL
2019-09-20
2021-06-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Cardiac Rehabilitation
people recruited for the trial will participate in the Intensive cardiac rehabilitation arm.
lifestyle modification
Participants will undergo an exercise program designed by AHH
Interventions
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lifestyle modification
Participants will undergo an exercise program designed by AHH
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
65 Years
85 Years
ALL
No
Sponsors
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Arkansas Heart Hospital
OTHER
Responsible Party
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Principal Investigators
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Leybi Ramirez Kelly
Role: STUDY_DIRECTOR
Arkansas Heart Hospital/Arkansas Site Management Services LLC
Locations
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Arkansas Heart Hospital-Clinic
Little Rock, Arkansas, United States
Countries
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References
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Bethell HJ. Cardiac rehabilitation: from Hellerstein to the millennium. Int J Clin Pract. 2000 Mar;54(2):92-7.
3. Cardiac Rehabilitation Updated: Oct 31, 2018 Author: Vibhuti N Singh, MD, MPH, FACC, FSCAI; Chief Editor: Consuelo T Lorenzo, MD
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.
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.
American College of Sports Medicine Position Stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 1998 Jun;30(6):992-1008.
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.
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.
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.
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.
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.
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.
Related Links
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Equipment used
Other Identifiers
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AHH-002
Identifier Type: -
Identifier Source: org_study_id
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