Cardiovascular Rehabilitation for Heart Disease

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Laval University

Disqualifiers: Inability to give consent

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to evaluate the hemodynamic changes in the forefoot of patients with coronary, cerebrovascular or peripheral atherosclerotic disease referred a 12-week cardiovascular rehabilitation program (PREV program). Also, this study will describe the characteristics of patients admitted to the PREV program and their evolutions in terms of favorable, unfavorable outcomes and complications and up to one year after completion of the program.

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 data supports the effectiveness of the treatment Cardiovascular Rehabilitation Program for heart disease?

Research shows that cardiovascular rehabilitation programs help people with heart disease by improving their quality of life, reducing the risk of future heart problems, and lowering death rates. These programs focus on healthy lifestyle changes and managing risk factors, which are important for long-term heart health. ^{1 2 3 4 5}

Is cardiovascular rehabilitation safe for humans?

Cardiovascular rehabilitation is generally considered safe for humans and has been shown to reduce mortality and improve quality of life in patients with heart conditions. It involves a comprehensive approach that includes physical, psychological, and social support, and is recommended by medical societies for various heart conditions. ^{3 6 7 8 9}

How is the Cardiovascular Rehabilitation Program treatment different from other treatments for heart disease?

The Cardiovascular Rehabilitation Program is unique because it focuses on improving quality of life and reducing future heart problems through a combination of regular physical activity, healthy lifestyle changes, and risk factor management, rather than relying solely on medication or surgery. ^{3 5 10 11 12}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Cardiovascular Rehabilitation Program (Behavioural Intervention)

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.

Participant Groups

Group I: Cardiovascular rehabilitation program Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Dr. Pedro O de Campos-Lima

Laval University

Chief Medical Officer since 1998

MD from Federal University of Juiz de Fora, PhD in Tumor Biology from Karolinska Institute

Dr. Manuel Caruso

Laval University

Chief Executive Officer since 1998

PhD in Virology from Pierre and Marie Curie University

CISSS de Chaudière-Appalaches

Collaborator

Trials

9

Recruited

16,500+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Mexico pubmed.ncbi.nlm.nih.gov

[Impact of cardiac rehabilitation programs on coronary risk profile]. [2008]

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

Cardiac rehabilitation secondary prevention programs. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[Cardiovascular rehabilitation - a current overview]. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

[Effects of inpatient rehabilitation on cardiovascular risk factors in patients with coronary heart disease. PIN-Study Group]. [2006]

5. England 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. [2009]

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

Changing clinical profile of patients entering cardiac rehabilitation/secondary prevention programs: 1996 to 2006. [2008]

7. England 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. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Cardiovascular rehabilitation]. [2021]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Nurse-led and Interdisciplinary Secondary Cardiovascular Prevention Programmes: Spanish Cohort of the EUROACTION Project. [2022]

10. Mexico pubmed.ncbi.nlm.nih.gov

[Return to work in patients with heart disease after cardiac rehabilitation]. [2017]

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

The challenge of cardiac rehabilitation. [2016]

12. England pubmed.ncbi.nlm.nih.gov

Quality service delivery in cardiac rehabilitation: cross-cultural challenges in an Australian setting. [2016]