Cardiac Rehabilitation for Blocked Arteries

(PREHAB-CTO Trial)

Overseen By Luiz F Ybarra, MD PhD MBA FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Luiz Ybarra

Disqualifiers: Severe valvular disease, Pregnancy, Cardiac transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the feasibility of a cardiac pre-hab program for patients with blocked arteries (CTO) who are referred for PCI treatment. The main questions it aims to answer are: Can the pre-hab program improve patients\' functional capacity before PCI? Does the pre-hab program impact the need for PCI based on improvements in patients\' health? Participants will: Undergo an initial assessment including a physical exam, medication history, quality of life questionnaires, and blood work. Complete a 6-month cardiac rehabilitation program. Have repeat assessments to evaluate improvements and determine if PCI is still needed. If PCI is performed, be assessed again one month later for functional capacity improvements. If PCI is not needed after 6 months, participants will be followed virtually for an additional 5 months.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cardiac Prehabilitation Program for blocked arteries?

Research shows that cardiac prehabilitation, which includes exercise and breathing training, can improve exercise capacity and quality of life in patients waiting for heart surgery. Similar programs have also been effective in reducing complications and hospital stays in other surgeries, suggesting potential benefits for blocked arteries. ^{1 2 3 4 5}

Is cardiac rehabilitation safe for people with blocked arteries?

Research shows that cardiac rehabilitation, including prehabilitation programs, is generally safe for people undergoing elective cardiac surgery. In a study, there were no significant differences in surgical or lung complications between those who did prehabilitation and those who received standard care, and only a small number of adverse events were related to the prehabilitation program. ^{1 6 7 8 9}

How is the Cardiac Prehabilitation Program different from other treatments for blocked arteries?

The Cardiac Prehabilitation Program is unique because it combines physical training with educational and counseling support before surgery, aiming to optimize patient outcomes and reduce complications, unlike traditional cardiac rehabilitation which typically occurs after surgery. ^{1 5 10 11 12}

Research Team

Luiz F Ybarra, MD PhD MBA FRCPC

Principal Investigator

London Health Sciences Centre

Eligibility Criteria

This trial is for patients with Chronic Total Occlusion (CTO), which means they have completely blocked arteries. They should be referred for a procedure called PCI but haven't had it yet. The study will check if a special exercise and health program before the treatment can help improve their heart's function.

Inclusion Criteria

I have a complete blockage in a major heart artery.

I need a procedure for a completely blocked artery due to chest pain or signs of heart muscle not getting enough blood.

Exclusion Criteria

I cannot or will not join the study's heart rehab program.

Life expectancy of < 12 months due to non-cardiovascular comorbidities

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-habilitation

Participants undergo a 6-month cardiac rehabilitation program including physical exercise, medical optimization, and lifestyle modifications.

6 months

Initial assessment, ongoing program participation

Assessment and Decision

Participants are reassessed to determine the need for PCI based on improvements in functional capacity.

1 month

Assessment visit

PCI and Post-PCI Assessment

If PCI is performed, participants are assessed one month later for functional capacity improvements.

1 month

Post-PCI assessment visit

Virtual Follow-up

If PCI is not needed, participants are followed virtually for an additional 5 months.

5 months

Virtual follow-up

Treatment Details

Interventions

• Cardiac Prehabilitation Program

Trial Overview The trial tests a 'pre-hab' cardiac rehabilitation program to see if it can boost patients' fitness levels before they undergo PCI, which is an artery-opening procedure. It also examines whether this pre-hab could reduce the need for PCI by improving patient health over six months.

Participant Groups

Group I: Cardiac Prehabilitation for CTO Patients Experimental Treatment 1 Intervention

This single arm involves a 6-month cardiac pre-habilitation program designed for patients with chronic total occlusions (CTO) who are referred for percutaneous coronary intervention (PCI). Participants receive personalized cardiac rehabilitation, which includes physical exercise, medical optimization, and lifestyle modifications. The program aims to improve functional capacity and overall health before PCI. Assessments will be conducted at the start, after 6 months, and one month post-PCI if performed, with ongoing virtual follow-up for 5 months if PCI is not needed.

Who Is Running the Clinical Trial?

Luiz Ybarra

Lead Sponsor

Trials

1

Recruited

70+

Academic Medical Organization of Southwestern Ontario

Collaborator

Trials

17

Recruited

1,600+

University of Western Ontario, Canada

Collaborator

Trials

168

Recruited

320,000+

Findings from Research

The cardiac prehabilitation (Prehab) program for patients awaiting elective coronary artery bypass graft (CABG) surgery showed promising results, with participants increasing their walking distance significantly compared to those receiving standard care.

Prehab participants also demonstrated improved gait speed and had a higher enrollment rate in cardiac rehabilitation three months post-surgery, indicating both feasibility and potential benefits for patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation program for elective coronary artery bypass graft surgery patients: a pilot randomized controlled study. Sawatzky, JA., Kehler, DS., Ready, AE., et al.[2022]

The PrEPS trial is a randomized controlled study involving 180 participants undergoing elective cardiac surgery, aiming to assess the feasibility and impact of a prehabilitation program that includes exercise and inspiratory muscle training on preoperative functional exercise capacity.

The primary outcome will measure changes in functional exercise capacity using the 6-minute walk test, while secondary outcomes will evaluate various factors such as respiratory function, quality of life, and postoperative complications, potentially improving overall patient outcomes before and after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation in elective patients undergoing cardiac surgery: a randomised control trial (THE PrEPS TRIAL) - a study protocol. Akowuah, E., Mathias, A., Bardgett, M., et al.[2023]

A comprehensive personalized teleprehabilitation program for patients scheduled for elective cardiac surgery aims to reduce major adverse cardiac events (MACE) and improve post-operative outcomes, utilizing a multidisciplinary approach over at least 6 weeks.

The program includes various modules such as exercise training, nutritional support, and psychological assistance, and is designed to address perioperative risk factors, potentially leading to better recovery and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized teleprehabilitation in elective cardiac surgery: a study protocol of the Digital Cardiac Counselling randomized controlled trial. Scheenstra, B., Mohansingh, C., Bongers, BC., et al.[2023]

In a study of 180 adult patients awaiting elective cardiac surgery, prehabilitation involving exercise and inspiratory muscle training did not significantly improve pre-operative functional exercise capacity compared to standard care, as measured by the six-minute walk test.

However, patients with sarcopenia in the prehabilitation group showed greater improvements in their walking distance, and the prehabilitation group had significantly better inspiratory muscle strength post-surgery, indicating potential benefits for specific patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of prehabilitation in patients undergoing elective cardiac surgery. Akowuah, EF., Wagnild, JM., Bardgett, M., et al.[2023]

In a study of 97 patients referred for prehabilitation before coronary artery bypass grafting (CABG), only 49% attended an initial intake visit, highlighting challenges in patient engagement with prehabilitation programs.

Patients who completed prehabilitation showed significantly higher rates of participation in postoperative cardiac rehabilitation and improvements in key health metrics, such as cardiorespiratory fitness and mental health, suggesting that prehabilitation can enhance recovery outcomes for CABG patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An observational study examining utilization of prehabilitation and its association with postoperative cardiac rehabilitation participation and risk factors following coronary artery bypass grafting. Rouleau, CR., Chirico, D., Hauer, T., et al.[2022]

Cardiac rehabilitation programs are generally safe and effective for improving the functional activities of patients with cardiac disease, but not all patients require supervised rehabilitation, especially those who were active before their cardiac event.

High-risk patients with low functional capacities (3-5 METs) benefit the most from rehabilitation, while low-risk patients (7-9 METs) may not need the program, indicating that rehabilitation should be tailored based on individual physical and psychological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation programs. Hotta, SS.[2010]

References

1. England pubmed.ncbi.nlm.nih.gov

Prehabilitation program for elective coronary artery bypass graft surgery patients: a pilot randomized controlled study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Impacts of Cardiac Rehabilitation Program on Exercise Capacity, Quality of Life, and Functional Status of Coronary Artery Disease Patients with Left Ventricular Dysfunction. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Prehabilitation in elective patients undergoing cardiac surgery: a randomised control trial (THE PrEPS TRIAL) - a study protocol. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of cardiac rehabilitation on self-reported health status after coronary artery bypass surgery. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Prehabilitation and heart failure: perspective in primary outcomes, a randomized controlled trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Personalized teleprehabilitation in elective cardiac surgery: a study protocol of the Digital Cardiac Counselling randomized controlled trial. [2023]

7. Spain pubmed.ncbi.nlm.nih.gov

[Prognostic effects of cardiac rehabilitation in patients with acute coronary syndrome]. [2023]

8. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of prehabilitation in patients undergoing elective cardiac surgery. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

An observational study examining utilization of prehabilitation and its association with postoperative cardiac rehabilitation participation and risk factors following coronary artery bypass grafting. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation programs. [2010]

11. Mexico pubmed.ncbi.nlm.nih.gov

[Effect of cardiac rehabilitation in ischemic patients not undergoing coronary revascularization]. [2019]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Modern strategies for cardiac rehabilitation after myocardial infarction and percutaneous coronary intervention]. [2020]