Exercise Training for Cardiovascular Disease

Overseen By Abeer M Mohamed, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Chronic heart, liver, kidney diseases, others

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

Compensation: Varies

Number of Visits: 36

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves exercise training, you should consult with your doctor to ensure your medications are compatible with the exercise program.

What data supports the effectiveness of the treatment Exercise training for cardiovascular disease?

Research shows that exercise training can improve heart health by increasing exercise tolerance, controlling risk factors, and potentially influencing heart disease progression. It also helps reduce depression and anxiety, leading to a better quality of life for heart patients. ^{1 2 3 4 5}

Is exercise training safe for people with cardiovascular disease?

Exercise training is generally safe for people with cardiovascular disease, with serious complications being exceptionally rare. Studies show that it can improve exercise capacity and quality of life, and while some nonfatal cardiac events have occurred, there were no fatalities reported. ^{6 7 8 9 10}

How is exercise training different from other treatments for cardiovascular disease?

Exercise training is unique because it focuses on improving heart health through physical activity rather than medication or surgery. It involves a variety of exercises tailored to individual needs, aiming to enhance endurance, strength, and flexibility, which can improve quality of life and potentially reduce the risk of future heart problems. ^{2 11 12 13 14}

What is the purpose of this trial?

The development of type II diabetes (T2D) is strongly associated with obesity and both are well-established risk factors for cardiovascular disease. Knowing that vascular dysfunction is an early event in the development of cardiovascular disease in obese diabetic (OB-T2D) patients, The investigators set their long-term goal to define molecular mechanisms of vascular dysfunction and corrective strategies that target these mechanisms such as physical activity and weight loss. The investigators recently discovered that human adipose tissues release extracellular vesicles (adiposomes) that are efficiently captured by endothelial cells. Adiposomes are known to carry bioactive cargos such as proteins and micro RNAs; however, their lipid content has not been studied nor has their ability to transfer their lipid cargo to endothelial cells. In the current application, the investigators propose to investigate the role of adiposomes in communicating the unhealthy milieu, mainly dysregulated lipids, to endothelial cells in OB-T2D subjects. On top of these lipid species that the investigators propose to be carried by adiposomes are glycosphingolipids (GSLs). These lipids originate from the glycosylation of ceramides, a chemical process that is upregulated in the presence of inflammation and high glucose levels. Preliminary findings showed that in endothelial cells, GSL-rich adiposomes disturb plasma membrane structure and subsequently induce endothelial dysfunction. Moreover, the investigators found that preconditioning endothelial cells with high shear stress (which is an exercise mimetic) protected endothelial cells from the detrimental effects induced by adiposomes. Therefore, the central hypothesis is that adipose tissues in OB-T2D patients release GSL-loaded adiposomes that induce vascular endothelial dysfunction. The researchers propose that exercise and weight loss interventions (bariatric surgery) will restore adipose tissue homeostasis, reduce GSL-loaded adiposomes, and subsequently alleviate vascular risk in OB-T2D patients. The investigators will test the hypotheses by pursuing the following aims: aim 1: Investigate the role of GSL-rich adiposomes in the pathogenesis of endothelial dysfunction in OB-T2D adults; aim 2: Test the effectiveness of exercise training in reducing adiposome-mediated effects on vascular function; and aim 3: Examine changes in adiposome/caveolae axis following metabolic surgery and their association with vascular function.

Research Team

Abeer M Mohamed, MD, PhD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

This trial is for adults aged 18-50 with obesity (BMI ≥ 35 kg/m2) and type II diabetes, who are not pregnant, can exercise moderately, and have no chronic heart, liver, kidney diseases or cancer. Smokers, drug/alcohol abusers, non-English speakers and those allergic to lidocaine cannot join.

Inclusion Criteria

I am diabetic or my fasting blood sugar is 126 mg/dL or higher.

My BMI is 35 or higher.

I am medically cleared for moderate exercise.

Exclusion Criteria

Current smokers

Currently abusing alcohol or drugs

I have a chronic condition like heart, liver, kidney disease, an autoimmune disease, or another cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Training

Participants undergo aerobic exercise training for 12 weeks, 3 times per week, 60 minutes per session

12 weeks

36 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Metabolic Surgery

Participants may undergo metabolic surgery to examine changes in adiposome/caveolae axis and their association with vascular function

Treatment Details

Interventions

• Exercise training

Trial Overview The study investigates how fat cells in obese diabetic patients affect blood vessel function by releasing 'adiposomes' that may carry harmful lipids. It will test if exercise training or weight loss surgery can reduce these effects and improve vascular health.

Participant Groups

Group I: Exercise training Experimental Treatment 1 Intervention

Aerobic exercise training for 12 weeks, 3 times per week, 60 minutes per session.

Group II: Control (standards of care) Active Control 1 Intervention

This arm will receive brochures for healthy lifestyle recommendations. No intervention will be conducted.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

The HF-ACTION trial aims to determine if exercise training can reduce all-cause mortality and hospitalization in patients with heart failure, involving 36 supervised sessions followed by home-based exercise over a 4-year period.

Exercise training is a low-cost and accessible intervention that may improve health outcomes for heart failure patients, with various physiological and quality-of-life measures being assessed throughout the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. Whellan, DJ., O'Connor, CM., Lee, KL., et al.[2007]

Regular exercise significantly benefits patients with heart disease by improving exercise tolerance, controlling risk factors, and potentially influencing the progression of coronary artery disease.

Patients should follow physician-guided exercise plans that include dynamic endurance activities and moderate-intensity circuit weight training, with a recommended duration of 2 to 3 hours per week, while high-risk patients should exercise at lower intensities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Heart patient and sports]. Niederhauser, HU.[2008]

A patient with Spontaneous Coronary Artery Dissection underwent 21 sessions of cardiac rehabilitation, which led to significant improvements in aerobic capacity, flexibility, and grip strength.

The rehabilitation program helped maintain stable anthropometric values, indicating that physical exercise can be an effective complementary therapy alongside medication for cardiac patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of cardiac rehabilitation in Primigravida with spontaneous coronary artery dissection during postpartum. Pinto, Mde C., Camargo, RC., Filho, JC., et al.[2021]

Exercise training significantly helps in preventing and modifying cardiovascular diseases and reducing mortality, highlighting its importance in patient care.

Patients with acute cardiovascular conditions benefit from structured cardiac rehabilitation programs, while those with chronic conditions should engage in lifelong home-based exercise routines that include aerobic, resistance, flexibility, and balance activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in cardiovascular diseases. Perez-Terzic, CM.[2022]

Exercise training is a safe and effective treatment for patients with heart failure, significantly improving their quality of life and functioning, yet it is underutilized despite being a guideline-recommended intervention.

A tailored exercise program that considers individual patient preferences and physiological capabilities is crucial for success, highlighting the need to overcome barriers related to patient access, physician awareness, and insurance coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise And Heart Failure: Advancing Knowledge And Improving Care. Alvarez, P., Hannawi, B., Guha, A.[2018]

In a study involving 25,420 patients undergoing cardiac rehabilitation, the rate of severe cardiovascular events during exercise training was very low, with only 20 serious events reported, indicating a high level of safety for patients participating in these programs.

The study found that the event rate was 1 per 49,565 patient-hours of exercise training, and there were no fatal complications or emergency defibrillations, suggesting that supervised exercise training is a safe practice for cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. Pavy, B., Iliou, MC., Meurin, P., et al.[2022]

In a study of 48 male patients with stable heart failure, those who engaged in continuous physical training for 6 months showed significant improvements in exercise tolerance and left ventricular (LV) ejection fraction compared to those who did not train.

The training group also experienced notable enhancements in both regional systolic and diastolic myocardial function, indicating that regular physical activity is beneficial for heart failure rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of continuous physical training on exercise tolerance and left ventricular myocardial function in patients with heart failure]. Deljanin-Ilić, M., Ilić, S., Stoickov, V.[2019]

Regular exercise training significantly improves quality of life and survival rates in both healthy individuals and patients with cardiovascular diseases, including those with stable heart failure.

In patients with heart failure classified as NYHA functional classes II and III, exercise training alleviates symptoms, enhances exercise capacity, and may reduce hospitalizations and mortality, highlighting its importance as a recommended treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in chronic heart failure: mechanisms and therapies. Piepoli, MF.[2022]

In a 4-week rehabilitation program for 431 patients who had a recent heart attack, 152 out of 235 patients with post-infarction angina experienced an improvement in their symptoms, indicating the program's efficacy in enhancing patient outcomes.

The program was conducted safely, with only 3 nonfatal cardiac events reported and no fatalities, while also leading to a significant increase in physical work capacity by an average of 19 Watts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of in-patient rehabilitation after myocardial infarction]. Niederhauser, HU., Müller, M., Steinbrunn, W.[2006]

Regular physical exercise significantly reduces ischaemic events and the progression of atheromatous disease in coronary patients, showing a 20% reduction in global mortality for coronary disease and 35% for cardiac failure based on recent meta-analyses.

Serious complications from cardiac rehabilitation are extremely rare, with data from over 25,000 patients indicating that physical training shortly after mitral valvuloplasty is safe and improves exercise capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Best of functional evaluation and cardiac rehabilitation in 2005]. Corone, S., Vergès, B., Iliou, MC., et al.[2009]

Cardiac rehabilitation programs are essential for patients with cardiovascular disease, focusing on exercise training to improve both physical and mental health, while also reducing the risk of future heart events.

The ideal exercise regimen for stable cardiac patients includes a mix of aerobic training, arm exercises, strength training, and flexibility exercises, which together help stabilize or reverse atherosclerosis and enhance overall recovery post-myocardial infarction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise following myocardial infarction. Current recommendations. Leon, AS.[2018]

Exercise training is an effective complementary treatment for patients with cardiovascular disease, improving both quality of life and prognosis across various conditions such as ischemic heart disease and heart failure.

Tailored exercise programs based on individual patient factors, including disease stage and exercise capacity, are essential for maximizing the benefits of exercise in cardiovascular rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise training in the therapy of heart diseases: Current evidence and future options]. Schwarz, S., Boscheri, A., Christle, J., et al.[2018]

Dynamic, nonisometric exercise training can enhance physical endurance and reduce cardiac workload during submaximal exertion in both individuals with coronary artery disease and healthy individuals, suggesting broad applicability of this training method.

Effective exercise regimens should involve training at 70-85% of maximal heart rate for at least 15-20 minutes, three times a week, and should be tailored to individual patient needs, ideally within medically supervised programs to ensure safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in coronary artery disease. Laslett, L., Paumer, L., Amsterdam, EA.[2007]

A diverse exercise training regimen for heart disease patients, incorporating various activities for both arms and legs, can lead to significant cardiovascular benefits.

Understanding the different physiological responses to various forms of exercise allows for safer and more effective training, resulting in improved muscular endurance, strength, and reduced ischemia, ultimately enhancing the quality of life for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Types of exercise. Arm-leg and static-dynamic. Balady, GJ.[2007]

References

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

Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. [2007]

2. Switzerland pubmed.ncbi.nlm.nih.gov

[Heart patient and sports]. [2008]

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

Influence of cardiac rehabilitation in Primigravida with spontaneous coronary artery dissection during postpartum. [2021]

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

Exercise in cardiovascular diseases. [2022]

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

Exercise And Heart Failure: Advancing Knowledge And Improving Care. [2018]

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

Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. [2022]

7. Serbia pubmed.ncbi.nlm.nih.gov

[Effects of continuous physical training on exercise tolerance and left ventricular myocardial function in patients with heart failure]. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise training in chronic heart failure: mechanisms and therapies. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

[Results of in-patient rehabilitation after myocardial infarction]. [2006]

10. France pubmed.ncbi.nlm.nih.gov

[Best of functional evaluation and cardiac rehabilitation in 2005]. [2009]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Exercise following myocardial infarction. Current recommendations. [2018]

12. Germany pubmed.ncbi.nlm.nih.gov

[Exercise training in the therapy of heart diseases: Current evidence and future options]. [2018]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise training in coronary artery disease. [2007]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Types of exercise. Arm-leg and static-dynamic. [2007]