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

NCT05708313 | Completed

• 1 other identifier: AHH-002
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases; Lifestyle Risk Reduction

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (9)

• Dartmouth Coop quality of Life Questionnaire

  Baseline to program completion (9-18 weeks)

• Hospital Re-admission rate

  Baseline to program completion (9-18 weeks)

• Patient Health Questionnaire (PHQ9)

  Baseline to program completion (9-18 weeks)

• Duke Activity Index

  Baseline to program completion (9-18 weeks)

• 6-minute walk test

  Baseline and at program completion (9-18 weeks)

Study Arms (1)

Cardiac Rehabilitation

EXPERIMENTAL

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

Behavioral: lifestyle modification

Interventions

lifestyle modification BEHAVIORAL

Participants will undergo an exercise program designed by AHH

Also known as: exercise

Cardiac Rehabilitation

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Arkansas Heart Hospital: lead

Study Sites (1)

Arkansas Heart Hospital-Clinic

Little Rock, Arkansas, 72211, United States

Location

Related Publications (11)

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

  PMID: 10824363 BACKGROUND

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

  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.

  PMID: 25490202 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.

  PMID: 11991917 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.

  PMID: 9624662 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.

  PMID: 23851406 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.

  PMID: 8595435 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.

  PMID: 19628486 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.

  PMID: 21385466 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.

  PMID: 24459173 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.

  PMID: 16713353 BACKGROUND

Related Links

• Equipment used

MeSH Terms

Conditions

Cardiovascular Diseases; Risk Reduction Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Leybi Ramirez Kelly

  Arkansas Heart Hospital/Arkansas Site Management Services LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Groups will be assigned to the exercise treatment group

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: February 1, 2023
• Study Start: September 20, 2019
• Primary Completion: June 27, 2021
• Study Completion: June 27, 2021
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)