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

Cardiovascular Diseases Clinical Trial

— AHH-ICR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05708313
• Other study ID #: AHH-002
• Status: Completed
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: June 27, 2021

Study information

• Verified date: January 2023
• Source: Arkansas Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 27, 2021
• Est. primary completion date: June 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Lifestyle Risk Reduction

Intervention

Behavioral:
• lifestyle modification
Participants will undergo an exercise program designed by AHH

Locations

Country	Name	City	State
United States	Arkansas Heart Hospital-Clinic	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Heart Hospital

Country where clinical trial is conducted

United States, 

References & Publications (11)

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

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Lipid	Total cholesterol, ADH, LDL and triglycerides (mg/dl)	Baseline to program completion (9-18 weeks)
Primary	Body Mass Index	calculated from Height and weight.	Baseline to program completion (9-18 weeks)
Primary	Resting Blood Pressure	Systolic and Diastolic Blood Pressure (mmHg)	Baseline to program completion (9-18 weeks)
Primary	Hemoglobin A1c	measure in whole blood (normal 4.5-6.2 (%))	Baseline to program completion (9-18 weeks)
Secondary	Dartmouth Coop quality of Life Questionnaire	Self-Reported assessment of participant general health	Baseline to program completion (9-18 weeks)
Secondary	Hospital Re-admission rate	Number of time patient is admitted to the hospital for cardiovascular related events.	Baseline to program completion (9-18 weeks)
Secondary	Patient Health Questionnaire (PHQ9)	Assessment of perceive depression state.	Baseline to program completion (9-18 weeks)
Secondary	Duke Activity Index	Assessment of physical Activity	Baseline to program completion (9-18 weeks)
Secondary	6-minute walk test	Distance walked in 6 minutes (mts)	Baseline and at program completion (9-18 weeks)
Secondary	Medication Changes	decrease medications intake..	Baseline to program completion (9-18 weeks)
Secondary	Perceived Exertion (RPE)	as perceived by patient in the Rating of perceived Exertion scale.	Baseline to program completion (9-18 weeks)
Secondary	Resting Metabolic Rate	measure in Kcal using the Mifflin-St. Jeor equation.	Baseline to program completion (9-18 weeks)
Secondary	Diet intake	food records using the Passio App.	Baseline to program completion (9-18 weeks)

External Links

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