Exercise Training for Heart Failure
Recruiting in Palo Alto (17 mi)
Overseen byDaniel H Katz, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Must not be taking: Insulin, Antidepressants, Antipsychotics, others
Disqualifiers: Diabetes, COPD, Cancer, others
No Placebo Group
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?The heart failure syndrome that occurs when the heart is too sick to properly do its job. One of the main symptoms is difficulty with exercise. One way to improve symptoms is to start patients in a 12 week exercise program called cardiac rehabilitation. Cardiac rehabilitation been shown to improve symptoms for heart failure patients. However, the investigators do not know exactly what exercise does to the molecules that make up the human body. If the investigators could answer this question, the investigators might find a whole new way to treat the symptoms of heart failure. Therefore the investigators want to know what molecules might be responsible for the benefits of exercise. The plan for this study is to measure the levels of thousands of proteins in blood samples which come from people with heart failure and see how those levels change after 12 weeks of cardiac rehabilitation, compared to the protein levels in patients whose cardiac rehabilitation is delayed until after the study period. If the investigators know the proteins that change with exercise, the investigators can then look to see if targeting these proteins with medicines can mimic the benefits of exercise. The long term goal of our work is to identify "exercise-in-a-pill" medicines that will help people with heart failure.
Will I have to stop taking my current medications?
The trial requires participants to stop taking certain medications, including steroids, insulin, and some psychiatric drugs. If you're on any of these, you may need to stop or adjust them before joining the study.
What data supports the effectiveness of the treatment for heart failure?
Research shows that cardiac rehabilitation, which includes exercise training, can improve exercise tolerance, reduce symptoms, and enhance quality of life for heart failure patients. It also helps reduce hospitalizations and improve heart function, making it a beneficial part of heart failure management.
12345Is exercise training safe for heart failure patients?
Exercise training, including cardiac rehabilitation, is generally considered safe for heart failure patients and can improve quality of life and functional capacity. Supervised settings are particularly effective in ensuring safety and maximizing benefits.
16789How does cardiac rehabilitation differ from other treatments for heart failure?
Cardiac rehabilitation is unique because it combines exercise training with lifestyle changes and psychological support, improving heart function and quality of life without medication. Unlike drug treatments, it focuses on physical activity tailored to each patient's tolerance, aiming to enhance overall health and reduce heart-related complications.
25101112Eligibility Criteria
This trial is for adults aged 18-89 with heart failure where the heart's pumping power is reduced (ejection fraction <40%). Participants must be willing to undergo cardiac rehabilitation and not be pregnant, planning pregnancy, or have given birth in the last year. They should not be on certain medications that could affect the study results or have had recent psychiatric hospitalizations.Inclusion Criteria
I am between 18 and 89 years old.
I am willing to join a heart health program.
Not be pregnant or lactating in the last 12 months, or planning to become pregnant for the next 4 months. A pregnancy test will be performed on the day of DXA scan in women of child-bearing potential. Not be post-partum during the last 12 months.
+2 more
Exclusion Criteria
I am taking medication for diabetes or to lower my blood sugar.
I am not taking any drugs to specifically increase muscle size.
My kidneys are not working well (GFR <60).
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Acute Exercise and Blood Sampling
Participants undergo a 40-minute bout of moderate intensity exercise with blood samples collected before and after at 10, 30, and 210 minutes.
1 day
1 visit (in-person)
Cardiac Rehabilitation
Participants engage in a 12-week exercise program called cardiac rehabilitation.
12 weeks
Regular visits (in-person)
Follow-up
Participants are monitored for changes in proteomic profiles and cardiopulmonary fitness after the intervention.
12 weeks
1 visit (in-person)
Participant Groups
The study aims to understand how a 12-week cardiac rehabilitation exercise program affects protein levels in blood samples of heart failure patients. By comparing these changes to those whose rehab is delayed, researchers hope to identify potential targets for 'exercise-in-a-pill' treatments.
2Treatment groups
Experimental Treatment
Active Control
Group I: Active arm: Acute exercise + 12 weeks Cardiac RehabilitationExperimental Treatment2 Interventions
This arm includes two-thirds of enrollees and focuses on both acute and chronic effects of exercise. Qualifying participants with heart failure randomized to this arm will undergo a 40 minute bout of moderate intensity exercise on a date prior to beginning in cardiac rehabilitation. Blood samples will be collected before and after the acute bout at 10, 30, and 210 minutes after exercise. Participants will then go to cardiac rehabilitation for a 12 week period. A single blood sample will be obtained at 6 weeks. The participants will return after the 12 weeks of cardiac rehabilitation for a second bout of acute exercise and blood sampling identical to the first. Finally, 12 weeks after completion of cardiac rehab, patients will return for another single blood sample.
Group II: Control arm: No exerciseActive Control1 Intervention
This arm includes one-third of enrollees and serves as control. Qualifying participants with heart failure randomized to this arm will begine with a 40 minute period of rest on a date prior to beginning in cardiac rehabilitation. Blood samples will be collected before and after the the 40 minute period at 10, 30, and 210 minutes after exercise. Participants will then defer cardiac rehabilitation for a 12 week period. A single blood sample will be obtained at 6 weeks of this control intervention period. The participants will return after the 12 weeks of control intervention for an actual bout of acute exercise and blood sampling identical to those completed by the active arm. They will then enter cardiac rehabilitation as per standard of care. Finally, 12 weeks after completion of cardiac rehab, patients will return for another single blood sample.
Cardiac rehabilitation is already approved in European Union, United States, Canada, Japan, Australia for the following indications:
🇪🇺 Approved in European Union as Cardiac rehabilitation for:
- Heart failure
- Coronary artery disease
- Post-myocardial infarction
🇺🇸 Approved in United States as Cardiac rehabilitation for:
- Heart failure
- Coronary artery disease
- Post-myocardial infarction
- Chronic obstructive pulmonary disease
🇨🇦 Approved in Canada as Cardiac rehabilitation for:
- Heart failure
- Coronary artery disease
- Post-myocardial infarction
🇯🇵 Approved in Japan as Cardiac rehabilitation for:
- Heart failure
- Coronary artery disease
🇦🇺 Approved in Australia as Cardiac rehabilitation for:
- Heart failure
- Coronary artery disease
- Post-myocardial infarction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford Health CareStanford, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
American Heart AssociationCollaborator
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
How to do: telerehabilitation in heart failure patients. [2019]According to the present guidelines for heart failure patients, regular exercise training has obtained the class of recommendation I, level of evidence A. Despite the benefits of cardiac rehabilitation, many heart failure patients are inactive. Common patient's rejection of existing forms of rehabilitation and limitations resulting from the disease itself hinder the outpatient cardiac rehabilitation. That is why home telerehabilitation seems to be the optimal form of physical activity for heart failure patients.
[Role of rehabilitation in the treatment of chronic heart insufficiency]. [2019]Rehabilitation is an important component of the modern comprehensive care plan for patients with chronic heart failure. Cardiac rehabilitation combines exercise training with therapeutical adaptations, behavioral modifications and psychosocial interventions. Based on these data, patients with controlled heart failure should be involved in cardiac rehabilitation programs. Training prescription needs a strict previous cardiac evaluation. Exercise training monitoring must be adjusted to the physical tolerance of each patient. Cardiac rehabilitation has been found to improve functional capacity, reduce symptoms, and finally reduce cardiac morbidity and mortality. These beneficial effects were associated with muscular, endothelial and ventilatory improvements. Reduced sympathetic tone may decrease arrhythmias and may limit the progression of left ventricular dysfunction.
[Cardiac rehabilitation for heart failure patients]. [2013]The benefits of cardiac rehabilitation for patients with heart failure are well documented: greater capacity during physical effort and improved quality of life, a reduction in comorbidities and in the number and duration of hospitalisations, etc. Physiotherapy is one of the tools of this specific and multidisciplinary care which is governed by protocols and which can be offered on an outpatient basis or during hospitalisation.
[Physical rehabilitation of patients suffering from chronic heart failure]. [2019]A BENEFICIAL METHOD: Heart failure combines with peripheral vascular and muscular abnormalities that can be effectively improved by rehabilitation. The data in the literature appears to demonstrate the efficacy and excellent tolerance of such exercise. Regarding functional results and improved quality of life, rehabilitation is as equally efficient as the medical treatment that it completes. It can currently be proposed to the majority of patients exhibiting left ventricular systolic dysfunction and who are are only partially improved with medical treatment alone. MODALITIES: The rehabilitation of heart failure must, optimally, be set-up in ambulatory settings, notably within the context of a health care network. Its modalities remain to be specified in on-going studies and its impact on prognosis has to be determined.
Exercise training in heart failure. [2019]Patients with heart failure challenge the clinician with a constellation of difficult clinical, pathophysiologic, and psychologic issues. As a result, until recently, exercise training was not considered a safe and effective treatment strategy to be used in these patients. However, in the past 10 years, data from both randomized and nonrandomized trials showed that regular exercise training in patients with stable Class II and III heart failure can safely improve exercise tolerance, attenuate an overactivated sympathetic nervous system, partially reverse skeletal muscle abnormalities, and enhance health-related quality of life. These outcomes are achievable with a relatively moderate dose of physical activity, such as 30 to 60 minutes of walking or cycling 3 to 5 days per week at an intensity equivalent to 60% to 70% of peak oxygen consumption. Sufficiently powered trials are needed to assess morbidity, mortality, and cost-effectiveness endpoints relative to exercise training in patients with heart failure.
Cardiac Rehabilitation for Patients With Heart Failure: JACC Expert Panel. [2021]Cardiac rehabilitation is defined as a multidisciplinary program that includes exercise training, cardiac risk factor modification, psychosocial assessment, and outcomes assessment. Exercise training and other components of cardiac rehabilitation (CR) are safe and beneficial and result in significant improvements in quality of life, functional capacity, exercise performance, and heart failure (HF)-related hospitalizations in patients with HF. Despite outcome benefits, cost-effectiveness, and strong practice guideline recommendations, CR remains underused. Clinicians, health care leaders, and payers should prioritize incorporating CR as part of the standard of care for patients with HF.
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.
Cardiac rehabilitation: a comprehensive program for the management of heart failure. [2019]Heart failure is one of the major health problems found in the United States today. Medical and interventional therapies play an important role in the treatment of this chronic condition, but they create a huge economic burden on the health care system. Nonpharmacologic interventions need further exploration. This article reviews research that examined the relationship between exercise and heart failure. A variety of exercise modalities measured outcomes of functional capacity and quality of life in both supervised and nonsupervised settings. Many investigators found exercise training to be safe and to confer benefits, especially on functional capacity, quality of life, and survival. The most favorable outcomes were observed in supervised settings. Cardiac rehabilitation provides an ideal environment for safe exercise and management of the health care needs of patients with heart failure. The multidisciplinary staff is adept at providing a paced approach to activity based on individualized exercise prescriptions, education, and management of this population's many comorbidities.
Safety and effects of physical training in chronic heart failure. Results of the Chronic Heart Failure and Graded Exercise study (CHANGE) [2007]Physical training is considered to be safe and beneficial as part of the treatment in heart failure patients. Prospective, sufficiently large studies are still needed to confirm this hypothesis.
[Exercise Training and Physical Activity in Patients with Heart Failure]. [2018]Exercise Training and Physical Activity in Patients with Heart Failure Abstract. Heart failure is a clinical syndrome with different etiologies and phenotypes. For all forms, supervised exercise training and individual physical activity are class IA recommendations in current guidelines. Exercise training can start in the hospital, immediately after stabilization of acute heart failure (phase I). After discharge, it can continue in a stationary or ambulatory prevention and rehabilitation program (phase II). Typical components are endurance, resistance and respiratory training. Health insurances cover costs for three to six months. Patients with implantable cardioverter defibrillators or left ventricular assist devices may train in experienced centers. Besides muscular reconditioning, a major goal of phase II is to increase health literacy to improve long-term adherence to physical activity. In phase III, heart groups offer support.
[Exercise training as a key component of heart failure therapy]. [2018]Physical exercise has been recognized as a standard therapy in the guidelines for secondary prevention of chronic heart failure. In clinical practice its benefits are widely underestimated. It is still too rarely applied as a therapeutic component, despite overwhelming scientific evidence, including meta-analyses illustrating the positive effect on exercise capacity, quality of life and hospitalization. It is crucial that patients undergo a thorough clinical investigation, including exercise testing and are in a clinically stable condition for at least 6 weeks under optimal guideline-conform medicinal therapy before exercise training is initiated. Moreover, it is important that only approved exercise regimens should be prescribed and exercise sessions should be appropriately monitored. Both moderate continuous endurance training and recently developed interval training have been shown to be safe and effective in chronic heart failure. Ideally, endurance training should be combined with moderate resistance training. Current evidence clearly demonstrates a dose-response relationship in the way that beneficial effects of exercise training are strongly related to factors such as exercise duration and intensity. Development of strategies that support long-term adherence to exercise training are a crucial challenge for both daily practice and future research.
[Physical activity and training in heart failure]. [2019]The main symptoms of chronic heart failure are dyspnea and exercise intolerance. The pathophysiological basis of these symptoms is not simply the dysfunction of the heart, but a complex interaction of the central circulation, the peripheral vessels, the skeletal muscles, the ventilatory, and the endocrine system. In contrast to acute heart failure, where bedrest is known to be beneficial, prolonged limitation of physical activity can be detrimental in the chronic stage of the disease. Therefore, since the 1980s there have been several reports about heart failure patients participating in exercise programs. The results were encouraging: the physiological gains were impressive, and contrary to prior fears, in the great majority of reports no deterioration of the cardiac function could be observed. The net result of training in this condition is an improvement in exercise capacity in the range of the best pharmacological treatment. In detail, blood flow into the working muscle is increased, the ventilation for each given workload is reduced, the skeletal muscle overall function (including biochemical and histological aspects) is improved, the increased neurohormonal activity--especially of the sympathico-adrenergic system--will be normalized, and the patient's quality of life is significantly improved. Whether all of these beneficial aspects will result in improved survival is not yet proven, although one recent study provides some evidence in this direction. But even if today no definite answer to this question from a large, multicenter trial is available, application of exercise training for selected heart failure patients can be recommended, if adequate supervision is provided.