Cardiovascular Rehabilitation for Heart Disease

Overseen By Caroline Marchand, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: Inability to give consent

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a 12-week cardiovascular rehab program affects blood flow in the foot for individuals with heart and artery problems. It aims to identify who benefits from this program and how they progress over time. The study suits anyone over 18 with conditions such as coronary artery disease, angina, or a history of stroke, and is part of the PREV program. As an unphased trial, it offers a unique opportunity to contribute to understanding the broader benefits of cardiovascular rehab.

Will I have to stop taking my current medications?

The trial information 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 prior data suggests that this cardiovascular rehabilitation program is safe for patients with heart disease?

Research has shown that cardiac rehab programs are safe and carry a low risk of complications. These programs improve heart health and reduce the likelihood of future heart issues. Participants often experience enhanced heart function and quality of life. Reports of negative side effects are rare, making it a well-tolerated option for those with heart disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cardiovascular rehabilitation programs for heart disease because they offer a comprehensive approach that goes beyond traditional treatments like medication or surgery. Unlike these standard options, which often focus on addressing immediate symptoms or preventing further damage, cardiovascular rehab combines exercise, education, and lifestyle changes to improve overall heart health and reduce future risks. This holistic method empowers patients to take control of their recovery and long-term health, potentially leading to better outcomes and a higher quality of life.

What evidence suggests that the Cardiovascular Rehabilitation Program is effective for heart disease?

Studies have shown that cardiac rehabilitation programs, like the one tested in this trial, effectively improve heart health. They reduce the risk of death and enhance the quality of life for people with heart disease. Research indicates that these programs aid recovery from heart-related events and can lead to shorter hospital stays. Cardiac rehabilitation includes exercise, education, and counseling to help patients manage their heart conditions. This approach is widely supported as an important part of preventing future heart problems. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with various heart and blood vessel conditions like coronary artery disease, stroke, or peripheral arterial disease. Participants should be referred to a 12-week cardiovascular rehabilitation program.

Inclusion Criteria

Have been admitted to the PREV program

I am 18 or older with a diagnosis of heart or artery disease.

Exclusion Criteria

I am unable to provide written consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cardiovascular Rehabilitation Program

Participants undergo a 12-week cardiovascular rehabilitation program to evaluate hemodynamic changes

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcomes assessed up to one year after program completion

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cardiovascular Rehabilitation Program

Trial Overview The study aims to observe changes in blood flow in the forefoot of patients with vascular diseases after they complete a specialized 12-week heart health improvement program.

How Is the Trial Designed?

Group I: Cardiovascular rehabilitation program Experimental Treatment 1 Intervention

Cardiovascular Rehabilitation Program is already approved in European Union, United States for the following indications:

Approved in European Union as Cardiovascular Rehabilitation Program for:

• Coronary artery disease
• Heart failure
• Peripheral arterial disease
• Post-myocardial infarction rehabilitation

Approved in United States as Cardiac Rehabilitation Program for:

• Coronary artery disease
• Heart failure
• Peripheral arterial disease
• Post-myocardial infarction rehabilitation

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

CISSS de Chaudière-Appalaches

Collaborator

Trials

9

Recruited

16,500+

Published Research Related to This Trial

The nurse-led cardiovascular prevention and rehabilitation program (CVPRP) significantly improved patients' adherence to European cardiovascular health recommendations, with notable increases in healthy behaviors such as fruit and vegetable consumption (98% vs. 53%) and physical activity (31% vs. 12.4%).

The program also led to better clinical outcomes, including improved blood pressure control (69% vs. 47.1%) and lower LDL cholesterol levels (86.1% vs. 67.6%), demonstrating its efficacy in managing risk factors for coronary heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-led and Interdisciplinary Secondary Cardiovascular Prevention Programmes: Spanish Cohort of the EUROACTION Project. Buigues, C., Trapero, I., Velasco, JA., et al.[2022]

Cardiac rehabilitation programs in Australia face significant challenges when serving culturally and linguistically diverse populations, as identified through interviews with 25 health professionals and observations in four rehabilitation programs.

Key obstacles include communication barriers and the need to align health messages with culturally specific factors like diet and family dynamics, highlighting the necessity for strategies to improve access and effectiveness of these services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality service delivery in cardiac rehabilitation: cross-cultural challenges in an Australian setting. Haghshenas, A., Davidson, PM.[2016]

Cardiac rehabilitation programs are essential for patients with coronary heart disease, as they help reduce disability and optimize cardiovascular risk through medication and lifestyle changes.

Regular physical activity is a key component of these programs, significantly lowering the risk of future cardiovascular events for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term secondary prevention programs after cardiac rehabilitation for the reduction of future cardiovascular events: focus on regular physical activity. Scrutinio, D., Temporelli, PL., Passantino, A., et al.[2009]

Cardiac rehabilitation (CR) is the most effective intervention for secondary prevention in coronary artery disease, significantly reducing morbidity and mortality, especially after heart attacks and in chronic heart failure.

The position paper provides practical recommendations for designing CR programs tailored to various cardiovascular conditions, emphasizing the need for structured delivery of these programs to all eligible patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary prevention through cardiac rehabilitation: from knowledge to implementation. A position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Piepoli, MF., Corrà, U., Benzer, W., et al.[2022]

Cardiac rehabilitation in Germany has shown a significant reduction in total mortality, myocardial infarction, and hospitalization rates over 1-2 years in 10,758 patients following myocardial infarction and bypass surgery, highlighting its efficacy as a secondary prevention strategy.

The program is recommended for various heart conditions, including congestive heart failure and post-surgical recovery, and future evaluations should focus on personalized interventions for different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiovascular rehabilitation]. Schwaab, B.[2021]

Rehabilitation and secondary prevention programs for patients with cardiovascular disease significantly improve mortality, morbidity, and quality of life, highlighting their importance alongside medical treatments.

Cardiologists are encouraged to recommend physical activity as a secondary prevention strategy for low-risk patients, while high-risk patients should be referred to specialists for tailored care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Impact of cardiac rehabilitation programs on coronary risk profile]. Ilarraza Lomelí, H.[2008]

In a study involving 65 patients with ischemic heart disease or valve disease, those who participated in a 1-month cardiac rehabilitation program had a 75% return-to-work rate compared to 60% in the control group, suggesting that rehabilitation significantly aids recovery.

Patients in the cardiac rehabilitation group experienced a mean disability time of 68 days before returning to work, which was significantly shorter than the 128 days in the control group, highlighting the program's effectiveness in reducing recovery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Return to work in patients with heart disease after cardiac rehabilitation]. Huichan-Muñoz, V., Justiniano-Cordero, S., Solís-Hernández, JL., et al.[2017]

Cardiac rehabilitation is essential for cardiovascular care, emphasizing the need for adequate funding and evidence showing its benefits on quality of life and cost-effectiveness.

Physical activity is a key component of cardiac rehabilitation, but it should be combined with programs that modify other risk factors for optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The challenge of cardiac rehabilitation. Dafoe, W.[2016]

Over a 10-year period, patients entering cardiac rehabilitation have become older and less fit, with a significant increase in obesity, diabetes, and hypertension among participants.

Despite these challenges, the use of evidence-based cardiovascular medications, especially statins, has tripled, leading to notable improvements in cholesterol levels and overall lipid profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing clinical profile of patients entering cardiac rehabilitation/secondary prevention programs: 1996 to 2006. Audelin, MC., Savage, PD., Ades, PA.[2008]

In a study of 2441 patients with coronary heart disease undergoing in-hospital rehabilitation, significant reductions in cardiovascular risk factors were observed, including a decrease in high blood pressure from 24% to 8% and smoking rates from 39% to 5%.

The study also found an increase in the prescription of essential medications during hospitalization, such as beta-blockers and cholesterol-lowering drugs, which supports the effectiveness of intensive drug treatment in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of inpatient rehabilitation on cardiovascular risk factors in patients with coronary heart disease. PIN-Study Group]. Völler, H., Hahmann, H., Gohlke, H., et al.[2006]

Cardiovascular rehabilitation is crucial for patients recovering from acute cardiovascular events and heart surgeries, as it significantly improves prognosis by reducing the risk of further events and enhancing quality of life.

Over the past 20 years, research has established rehabilitation as a key component of treatment guidelines, reflecting advancements in interventional techniques and medical therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiovascular rehabilitation - a current overview]. Baumgärtner, R.[2020]

Cardiac rehabilitation programs significantly improve patient outcomes by reducing mortality, enhancing quality of life, and improving cardiac risk factors for those with cardiovascular disease.

Despite the benefits, 80% of eligible patients do not participate in these programs, often due to lack of insurance coverage, but physician endorsement can greatly increase participation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation secondary prevention programs. Womack, L.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11588675/

The Effectiveness of Cardiac Rehabilitation Programs in ... Across the identified studies, the results revealed that CR programs have a beneficial effect on cardiovascular outcomes, which validated this ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001289

Core Components of Cardiac Rehabilitation Programs Cardiac rehabilitation (CR) reduces mortality rates and improves the quality of life of patients with cardiovascular disease (CVD), and its use ...

3. nature.com nature.com/articles/s44325-024-00017-7

Cardiac rehabilitation and secondary prevention of CVD These advancements have resulted in more people surviving initial events and having reduced length of stay in hospital; consequently, there is ...

4. globalheartjournal.com globalheartjournal.com/articles/10.5334/gh.1480

Cardiac Rehabilitation in Patients with Coronary ... Cardiac rehabilitation (CR) is a cornerstone of secondary prevention in coronary heart disease, supported by robust evidence and classified ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK537196/

Cardiac Rehabilitation - StatPearls - NCBI Bookshelf Cardiac rehabilitation is a supervised program recommended for patients recovering from cardiovascular events.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8445013/

The role of cardiac rehabilitation in improving cardiovascular ... This meta-analysis showed that participation in cardiac rehabilitation was associated with reduced rates of all-cause and heart-failure-specific ...

7. e-jci.org e-jci.org/DOIx.php?id=10.54912/jci.2024.0003

The History and Overview of Cardiac Rehabilitation ... The article provides a comprehensive overview of CR and secondary prevention, covering various aspects from their historical development to contemporary ...