Exercise Training for Cardiovascular Disease
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Illinois at Chicago
Disqualifiers: Chronic heart, liver, kidney diseases, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
211121314Eligibility 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 between 18 and 50 years old.
+2 more
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.
+3 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise trainingExperimental Treatment1 Intervention
Aerobic exercise training for 12 weeks, 3 times per week, 60 minutes per session.
Group II: Control (standards of care)Active Control1 Intervention
This arm will receive brochures for healthy lifestyle recommendations. No intervention will be conducted.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Illinois at ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of Illinois at ChicagoLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. [2007]Although there are limited clinical data to support the use of exercise training as a means to reduce mortality and morbidity in patients with heart failure, current guidelines state that exercise is beneficial.
[Heart patient and sports]. [2008]Patients with heart disease may benefit from scheduled exercising in different ways. Exercise tolerance is increased, risk factors are controlled, and even progression and regression of coronary artery disease can be influenced by training and diet. Psychological effects include lessened depression and reduced anxiety. Overall, regular physical activity is important for maintenance of health and may lead to a better quality of life. In order to minimize the risk of training, the patients should be provided with guidelines for exercising by the physician. Activities should include dynamic endurance exercises and properly selected calisthenics (without a need for high technical skills). Circuit weight training of moderate intensity is helpful for promoting muscle strength. Training has to be followed not less than 2 to 3 hours per week in at least three sessions at an intensity corresponding to 60 to 85% of the maximum heart rate achieved in a symptom-limited maximum exercise-test. Cardiac patients at high risk (decreased left ventricular function, persisting ischaemia, low exercise capacity, severe symptoms, older age) should exercise at lower intensities.
Influence of cardiac rehabilitation in Primigravida with spontaneous coronary artery dissection during postpartum. [2021]The physical exercise consists of trainable physical abilities such as strength and endurance. It can be inferred that the individual cardiac patient is dependent on it as an associated therapy to the drug treatment for a rapid and lasting improvement of their overall clinical status.
Exercise in cardiovascular diseases. [2022]Analysis of extensive data has shown that exercise training provides significant impact on prevention and modification of cardiovascular diseases and mortality. In general, exercise recommendations for patients with cardiovascular diseases are based on individual aerobic capacity and comorbidities. Patients with acute syndromes benefit from participating in a cardiac rehabilitation program, whereas patients with chronic syndromes benefit from a life-long home-based program. In general, exercise prescription should involve aerobic activities in combination with resistance, flexibility, and balance exercises. This review will discuss an exercise prescription for patients with coronary artery disease, heart failure, and after heart transplantation. Detailed precautions for particular groups of patients will be discussed.
Exercise And Heart Failure: Advancing Knowledge And Improving Care. [2018]Exercise limitation is the hallmark of heart failure, and an increasing degree of intolerance is associated with poor prognosis. Objective evaluation of functional class (e.g., cardiopulmonary exercise testing) is essential for adequate prognostication in patients with advanced heart failure and for implementing an appropriate exercise training program. A graded exercise program has been shown to be beneficial in patients with heart failure and has become an essential component of comprehensive cardiac rehabilitation in these patients. An exercise program tailored to the patient's preferences, possibilities, and physiologic reserve has the greatest chance of being successful. Despite being safe, effective, and a guideline-recommended treatment to improve quality of life, exercise training remains grossly underutilized. Patient, physician, insurance and practice barriers need to be addressed to improve this quality gap.
Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. [2022]Cardiac rehabilitation is widely recognized as a medical management procedure that reduces mortality, but the cardiovascular safety of exercise training has not been clearly established. Published data are retrospective or outdated, as patient management has substantially progressed in recent years. The aim of this prospective registry was to determine the current complication rate during exercise performed in the course of cardiac rehabilitation.
[Effects of continuous physical training on exercise tolerance and left ventricular myocardial function in patients with heart failure]. [2019]Physical training is an important method in the rehabilitation programme for cardiovascular patients. Nevertheless, some controversies about physical training in patients with heart failure still exist.
Exercise training in chronic heart failure: mechanisms and therapies. [2022]Decreased exercise capacity negatively affects the individuals' ability to adequately perform activities required for normal daily life and, therefore, the independence and quality of life. Regular exercise training is associated with improved quality of life and survival in healthy individuals and in cardiovascular disease patients. Also in patients with stable heart failure, exercise training can relieve symptoms, improve exercise capacity and reduce disability, hospitalisation and probably mortality. Physical inactivity can thus be considered a major cardiovascular risk factor, and current treatment guidelines recommend exercise training in patients with heart failure in NYHA functional classes II and III. Exercise training is associated with numerous pulmonary, cardiovascular, and skeletal muscle metabolic adaptations that are beneficial to patients with heart failure. This review discusses current knowledge of mechanisms by which exercise training is beneficial in these patients.
[Results of in-patient rehabilitation after myocardial infarction]. [2006]431 of 435 patients with recent myocardial infarction completed our clinic's 4-week rehabilitation program in 1979. 235 presented with post-infarction angina pectoris (a.p.). Of these patients, 152 achieved a decrease of one or more a.p. functional classes, 70 remained in the same class and in 12 the symptoms worsened by one or more classes. The mean physical work capacity under maximal bicycle-stress test increased by 19 Watt. Overall ventricular arrhythmia frequency under stress remained unchanged from beginning to end of our program. Individual arrhythmia frequency, however, varied widely with or without antiarrhythmic drug therapy. During exercise training, 3 nonfatal cardiac events occurred. There were no fatalities. It is concluded that our training program can be performed relatively safely and that physical work capacity can be increased during the rehabilitation program.
[Best of functional evaluation and cardiac rehabilitation in 2005]. [2009]The latest in cardiac rehabilitation has been impacted by: The East German PET publication which showed fewer ischaemic events and progression of the atheromatous disease in symptomatic and stable coronary patients who carry out regular physical exercise in comparison with patients who underwent angioplasty with stenting. Two meta-analyses updated the data showing the benefits of physical training: a 20% reduction in global mortality in coronary disease and 35% in cardiac failure. Two French studies reporting reassuring data for our daily practice: the serious complications of cardiac rehabilitation are exceptionally rare: the register for 2003 with data from 65 French centres, over 25,000 patients and 743,000 patient/exercise hours. Physical training two weeks after mitral valvuloplasty is not harmful for the valve repair and is beneficial in terms of exercise capacity for the patient. Epidemiological studies showing that women and elderly patients are, unfortunately, often excluded from programmes of cardiac rehabilitation.
Exercise following myocardial infarction. Current recommendations. [2018]Cardiac rehabilitation services are comprehensive long term programmes designed to limit the physiological and psychological effects of cardiovascular disease (CVD), control cardiac symptoms and reduce the risk of subsequent CVD events by stabilising or partially reversing the underlying atherosclerosis process through risk factor modification. Exercise training is the cornerstone of such programmes. Ideally, exercise conditioning or training for the stable cardiac patient should include a combination of cardiorespiratory endurance (aerobic) training, arm exercises and muscular conditioning resistance (strength) training. Flexibility exercises should also be performed, usually as part of the warm-up and cool-down routines preceding and following endurance and strength training. This review discusses the potential physiological, psychological and health benefits of regular exercise and provides guidelines for exercise training for the rehabilitation of post-myocardial infarction patients following hospitalisation.
[Exercise training in the therapy of heart diseases: Current evidence and future options]. [2018]Exercise training has been firmly established as an additional therapeutic strategy in addition to pharmacological and interventional treatment in patients with cardiovascular disease. Benefits for quality of life as well as prognosis have been confirmed for cardiovascular risk factors, ischemic heart disease, after myocardial infarction, in heart failure with preserved as well as reduced ejection fraction, in atrial fibrillation and in patients after catheter-assisted aortic valve implantation (TAVI), with an implantable cardioverter defibrillator (ICD) or with left ventricular assist devices (VAD). Training programs have to be tailored according to the disease, stage of disease, comorbidities, age of the patient, medication as well as exercise capacity. For prescribing exercise mode and intensity, a maximum exercise test has to be performed. Ideally, this is accompanied by spirometry to assess maximum values such as maximum oxygen consumption. Training intensity will then be prescribed according to the optimal training range and maximum training intensity.
Exercise training in coronary artery disease. [2007]Physical training using dynamic, nonisometric exercise can increase physical endurance and decrease cardiac work load of submaximal exertion. This is true for people with coronary artery disease and for normal individuals, and it may also be true for those with selected other cardiac diseases. Effective training should involve exercise at between 70 and 85 per cent of predicted maximal heart rate for 15 to 20 minutes or more at least three times a week. An exercise prescription should be written on the basis of individual patient needs and limitations and utilizing an exercise electrocardiogram test. Medically supervised exercise programs allow physical training for patients with heart disease to be conducted safely and efficiently. The effect of training in coronary disease patients is primarily attributable to increased efficiency of peripheral musculature and circulation; how much true cardiac adaptation results is variable. Training improves psychologic outlook, probably reduces selected risk factors for coronary disease, and may improve longevity.
Types of exercise. Arm-leg and static-dynamic. [2007]Exercise training for patients with heart disease is no longer limited to a monotonous single-activity routine. Training regimens can and should employ a wide variety of activities that involve the arms and legs and both dynamic and static effort (Table 3). Because the physiologic and, hence, ischemic responses to each type of exercise are different, the unique properties of the varying forms of exercise must be well understood. Significant cardiovascular benefit can be derived from a training program that employs a diversity of activities in a safe and effective manner. Improvements in muscular endurance and strength, with reductions in ischemia, can translate to a more satisfying and productive life for the patient with heart disease.