Cardiovascular DiseasesAHH-ICRNCT05708313

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

A study testing lifestyle modification in people with Cardiovascular Diseases and Lifestyle Risk Reduction, run by Arkansas Heart Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 65 to 85 years
Conditions the study is for: Cardiovascular Diseases, Lifestyle Risk Reduction
What is being tested?: lifestyle modification
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 198 participants
Where: 1 siteUnited States
Study dates: 20 Sep 2019to 27 Jun 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 85 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

Show all 9Show fewer

Percutaneous transluminal coronary angioplasty or coronary stenting
BMI ≥ 18 ≤35
HgA1C ≤10

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Arkansas Heart Hospital-Clinic
Little Rock, Arkansas, 72211

Other trials in United States

About this study

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

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

AHH-ICR will increase patients physical and psychological well-being and is non-superior/comparable to current ICR programs.
To determine the most appropriate ICR program protocols to improve fitness and decrease cardiovascular risk factors.
To determine if the ICR program has a direct relationship to improvements in the health of cardiovascular patients.
To determine non-inferiority to already established ICR programs in the United States.

Conditions: Cardiovascular Diseases, Lifestyle Risk Reduction
Being tested: lifestyle modification
Medical subject headings: Cardiovascular Diseases, Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lifestyle modificationBehavioural
Also called exercise
Participants will undergo an exercise program designed by AHH

Study groups in NCT05708313
Study group	Role	What they receive
Cardiac Rehabilitation	Experimental	people recruited for the trial will participate in the Intensive cardiac rehabilitation arm. Receives: Behavioral: lifestyle modification

What is being measured

The primary outcome is the main question the study is designed to answer.

Serum Lipid
Total cholesterol, ADH, LDL and triglycerides (mg/dl)
Measured: Baseline to program completion (9-18 weeks)
Body Mass Index
calculated from Height and weight.
Measured: Baseline to program completion (9-18 weeks)
Resting Blood Pressure
Systolic and Diastolic Blood Pressure (mmHg)
Measured: Baseline to program completion (9-18 weeks)
Hemoglobin A1c
measure in whole blood (normal 4.5-6.2 (%))
Measured: Baseline to program completion (9-18 weeks)

Secondary outcomes (9)

Dartmouth Coop quality of Life Questionnaire
Self-Reported assessment of participant general health
Measured: Baseline to program completion (9-18 weeks)
Hospital Re-admission rate
Number of time patient is admitted to the hospital for cardiovascular related events.
Measured: Baseline to program completion (9-18 weeks)
Patient Health Questionnaire (PHQ9)
Assessment of perceive depression state.
Measured: Baseline to program completion (9-18 weeks)
Duke Activity Index
Assessment of physical Activity
Measured: Baseline to program completion (9-18 weeks)
6-minute walk test
Distance walked in 6 minutes (mts)
Measured: Baseline and at program completion (9-18 weeks)
Medication Changes
decrease medications intake..
Measured: Baseline to program completion (9-18 weeks)
Perceived Exertion (RPE)
as perceived by patient in the Rating of perceived Exertion scale.
Measured: Baseline to program completion (9-18 weeks)
Resting Metabolic Rate
measure in Kcal using the Mifflin-St. Jeor equation.
Measured: Baseline to program completion (9-18 weeks)
Diet intake
food records using the Passio App.
Measured: Baseline to program completion (9-18 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 201927 Jun 2021

First posted1 Feb 2023
Study start20 Sep 2019
Primary completion27 Jun 2021
Study completion27 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: Groups will be assigned to the exercise treatment group
Masking: None (open label)
Enrolment: 198 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05708313
Sponsor's protocol ID: AHH-002
Acronym: AHH-ICR
Status last verified: Jan 2023
First submitted: 9 Jan 2023
Last updated: 1 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data will not be share with other investigators outside of the research facility unless is for data analysis and publication

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)

All Cardiovascular Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of 9-18 Weeks of Intensive Cardiac Rehabilitation After a Major Cardiovascular Event in Patients With Cardiovascular Disease-AHH-ICR
ClinicalTrials.gov ID: NCT05708313
Acronym / sponsor ID: AHH-ICR / AHH-002
Conditions: Cardiovascular Diseases, Lifestyle Risk Reduction
Study type: Interventional
Recruitment status: Completed
Enrolment: 198 participants (actual)
Lead sponsor: Arkansas Heart HospitalUniversity, hospital or other
Study start: 20 Sep 2019 (actual)
Primary completion: 27 Jun 2021 (actual)
Study completion: 27 Jun 2021 (actual)
First posted: 1 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Implement the ICR Program to determine if

AHH-ICR will increase patients physical and psychological well-being and is non-superior/comparable to current ICR programs.
To determine the most appropriate ICR program protocols to improve fitness and decrease cardiovascular risk factors.
To determine if the ICR program has a direct relationship to improvements in the health of cardiovascular patients.
To determine non-inferiority to already established ICR programs in the United States.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Groups will be assigned to the exercise treatment group

Arm	Type	Receives
Cardiac Rehabilitation	Experimental	Behavioral: lifestyle modificationpeople recruited for the trial will participate in the Intensive cardiac rehabilitation arm.

Who may qualify

Ages: 65 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (9 listed)

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)

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lifestyle modificationAlso: exerciseParticipants will undergo an exercise program designed by AHH	Behavioural	Cardiac Rehabilitation

Primary outcome

Serum Lipid
Time frame: Baseline to program completion (9-18 weeks)
Total cholesterol, ADH, LDL and triglycerides (mg/dl)
Body Mass Index
Time frame: Baseline to program completion (9-18 weeks)
calculated from Height and weight.
Resting Blood Pressure
Time frame: Baseline to program completion (9-18 weeks)
Systolic and Diastolic Blood Pressure (mmHg)
Hemoglobin A1c
Time frame: Baseline to program completion (9-18 weeks)
measure in whole blood (normal 4.5-6.2 (%))

9 secondary outcomes

Dartmouth Coop quality of Life Questionnaire
Time frame: Baseline to program completion (9-18 weeks)
Hospital Re-admission rate
Time frame: Baseline to program completion (9-18 weeks)
Patient Health Questionnaire (PHQ9)
Time frame: Baseline to program completion (9-18 weeks)
Duke Activity Index
Time frame: Baseline to program completion (9-18 weeks)
6-minute walk test
Time frame: Baseline and at program completion (9-18 weeks)
Medication Changes
Time frame: Baseline to program completion (9-18 weeks)
Perceived Exertion (RPE)
Time frame: Baseline to program completion (9-18 weeks)
Resting Metabolic Rate
Time frame: Baseline to program completion (9-18 weeks)
Diet intake
Time frame: Baseline to program completion (9-18 weeks)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
Background: PubMed 10824363Bethell HJ. Cardiac rehabilitation: from Hellerstein to the millennium. Int J Clin Pract. 2000 Mar;54(2):92-7.
Background3. Cardiac Rehabilitation Updated: Oct 31, 2018 Author: Vibhuti N Singh, MD, MPH, FACC, FSCAI; Chief Editor: Consuelo T Lorenzo, MD
Background: PubMed 25490202Razavi 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.
Background: PubMed 11991917Hill J, Timmis A. Exercise tolerance testing. BMJ. 2002 May 4;324(7345):1084-7. doi: 10.1136/bmj.324.7345.1084. No abstract available.
Background: PubMed 9624662American College of Sports Medicine Position Stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 1998 Jun;30(6):992-1008.
Background: PubMed 23851406Thompson 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.
Background: PubMed 8595435Wenger 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.
Background: PubMed 19628486Kothmann 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.
Background: PubMed 21385466Rosenfeldt 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.
Background: PubMed 24459173Sawatzky 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.
Background: PubMed 16713353Hadj 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.
Equipment usedLink provided by the sponsor.
Individual participant dataSharing planned: No. Data will not be share with other investigators outside of the research facility unless is for data analysis and publication

Related trials for Cardiovascular Diseases

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leybi Ramirez Kelly study director

Arkansas Heart Hospital/Arkansas Site Management Services LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing lifestyle modification in people with Cardiovascular Diseases and Lifestyle Risk Reduction, run by Arkansas Heart Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Lipid (time frame: Baseline to program completion (9-18 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05708313, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.