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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-20

Study Completion Date

2021-06-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases Lifestyle Risk Reduction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Groups will be assigned to the exercise treatment group
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cardiac Rehabilitation

people recruited for the trial will participate in the Intensive cardiac rehabilitation arm.

Group Type EXPERIMENTAL

lifestyle modification

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Other Intervention Names

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exercise

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arkansas Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

References

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Bethell HJ. Cardiac rehabilitation: from Hellerstein to the millennium. Int J Clin Pract. 2000 Mar;54(2):92-7.

Reference Type BACKGROUND
PMID: 10824363 (View on PubMed)

3. Cardiac Rehabilitation Updated: Oct 31, 2018 Author: Vibhuti N Singh, MD, MPH, FACC, FSCAI; Chief Editor: Consuelo T Lorenzo, MD

Reference Type 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.

Reference Type BACKGROUND
PMID: 25490202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11991917 (View on PubMed)

American College of Sports Medicine Position Stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 1998 Jun;30(6):992-1008.

Reference Type BACKGROUND
PMID: 9624662 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23851406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8595435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19628486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21385466 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24459173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16713353 (View on PubMed)

Related Links

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Other Identifiers

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AHH-002

Identifier Type: -

Identifier Source: org_study_id

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