ClinicalTrials.gg
CompletedNCT05708313AHH-ICRUpdated Feb 1, 2023

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

An interventional study of lifestyle modification in Cardiovascular Diseases and Lifestyle Risk Reduction, sponsored by Arkansas Heart Hospital. Completed at 1 site in United States. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-02-01.

Sponsored by Arkansas Heart Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Sep 2019, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
198
Allocation
Not applicable
Ages
65 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed 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.
02

Conditions studied

  • Cardiovascular Diseases
  • Lifestyle Risk Reduction
03

In context

Cardiovascular Diseases

5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.

This study's enrollment of 198 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Arkansas Heart Hospital is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. ≥ 18 ≤35
  9. HgA1C ≤10

Exclusion 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. /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.
  1. 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
198 participants (actual)

Study arms

  • Experimental
    Cardiac Rehabilitation

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

    Behavioral: lifestyle modification

Interventions

  • Behaviorallifestyle modification

    Participants will undergo an exercise program designed by AHH

    Also known as: exercise

06

What researchers measure

Primary outcomes

  1. Serum Lipid

    Total cholesterol, ADH, LDL and triglycerides (mg/dl)

    Time frame: Baseline to program completion (9-18 weeks)

  2. Body Mass Index

    calculated from Height and weight.

    Time frame: Baseline to program completion (9-18 weeks)

  3. Resting Blood Pressure

    Systolic and Diastolic Blood Pressure (mmHg)

    Time frame: Baseline to program completion (9-18 weeks)

  4. Hemoglobin A1c

    measure in whole blood (normal 4.5-6.2 (%))

    Time frame: Baseline to program completion (9-18 weeks)

Secondary outcomes

  1. Dartmouth Coop quality of Life Questionnaire

    Self-Reported assessment of participant general health

    Time frame: Baseline to program completion (9-18 weeks)

  2. Hospital Re-admission rate

    Number of time patient is admitted to the hospital for cardiovascular related events.

    Time frame: Baseline to program completion (9-18 weeks)

  3. Patient Health Questionnaire (PHQ9)

    Assessment of perceive depression state.

    Time frame: Baseline to program completion (9-18 weeks)

  4. Duke Activity Index

    Assessment of physical Activity

    Time frame: Baseline to program completion (9-18 weeks)

  5. 6-minute walk test

    Distance walked in 6 minutes (mts)

    Time frame: Baseline and at program completion (9-18 weeks)

  6. Medication Changes

    decrease medications intake..

    Time frame: Baseline to program completion (9-18 weeks)

  7. Perceived Exertion (RPE)

    as perceived by patient in the Rating of perceived Exertion scale.

    Time frame: Baseline to program completion (9-18 weeks)

  8. Resting Metabolic Rate

    measure in Kcal using the Mifflin-St. Jeor equation.

    Time frame: Baseline to program completion (9-18 weeks)

  9. Diet intake

    food records using the Passio App.

    Time frame: Baseline to program completion (9-18 weeks)

07

Study locations

1 site
  • Arkansas Heart Hospital-Clinic
    Little Rock, Arkansas 72211, United States
08

References and documents

Publications

  • Bethell HJ. Cardiac rehabilitation: from Hellerstein to the millennium. Int J Clin Pract. 2000 Mar;54(2):92-7. PubMed 10824363 ↗
  • 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. PubMed 25490202 ↗
  • 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. PubMed 11991917 ↗
  • American College of Sports Medicine Position Stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 1998 Jun;30(6):992-1008. PubMed 9624662 ↗
  • 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. PubMed 23851406 ↗
  • 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. PubMed 8595435 ↗
  • 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. PubMed 19628486 ↗
  • 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. PubMed 21385466 ↗
  • 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. PubMed 24459173 ↗
  • 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. PubMed 16713353 ↗

Related links

Individual participant data

Plan to share: No — Data will not be share with other investigators outside of the research facility unless is for data analysis and publication

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05708313
Lead sponsor
Arkansas Heart Hospital
Responsible party
Sponsor
First posted
Feb 1, 2023
Start date
Sep 20, 2019
Primary completion
Jun 27, 2021
Completion
Jun 27, 2021
Last update
Feb 1, 2023

Study contacts

Leybi Ramirez Kelly
study director · Arkansas Heart Hospital/Arkansas Site Management Services LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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