Exercise Training for Heart Failure
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Must not be taking: Hormone replacement therapy
Disqualifiers: Prior EF <50%, NYHA Class IV, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
Heart failure with preserved ejection (HFpEF) disproportionately affects Veterans and is the number one reason for hospital discharge in the VA Health Care System. Exercise intolerance is a common complication experienced by patients with HFpEF, perpetuating physical inactivity and accelerating disease progression. This research proposal aims to elucidate mechanisms responsible for inadequate skeletal muscle blood flow and exercise intolerance in patients with HFpEF compared with healthy controls as well as following 8 weeks of exercise training in patients with HFpEF only.
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, it does mention that heart failure must be stabilized on optimized pharmacotherapy, which suggests that you may need to continue certain medications.
What data supports the effectiveness of this treatment for heart failure?
Is exercise training safe for people with heart failure?
How is exercise training different from other treatments for heart failure?
Exercise training is unique because it improves heart failure symptoms by enhancing exercise capacity and quality of life without worsening heart function. Unlike medications, it involves physical activity like aerobic and resistance exercises, which help the heart and muscles adapt positively, reducing the risk of hospitalization and possibly mortality.14101112
Eligibility Criteria
This trial is for adults with heart failure who can consent, have a specific type of heart failure (HFpEF) where the heart pumps well but is stiff, and show certain blood markers. It's not for those with severe heart issues, orthopedic limits that prevent exercise, women on hormone therapy, smokers, or pregnant women.Inclusion Criteria
I am 18 or older and can sign a consent form.
My heart condition limits my physical activity but I can still perform light tasks.
Plasma Brain Natriuretic Peptide (BNP) >200 pg/mL or NT-proBNP 400 pg/mL at enrollment
See 1 more
Exclusion Criteria
My heart failure is severe and cannot be managed with medication.
My heart failure is not due to a major untreated valve problem, except for a specific type of leaky heart valve caused by heart muscle weakness.
I have a heart condition such as acute coronary syndrome, infiltrative cardiomyopathy, or myocarditis.
See 5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Cross-sectional Comparison
Cross-sectional comparison of patients with HFpEF and healthy controls
Not specified
Exercise Training
Patients with HFpEF undergo 8 weeks of supervised knee extensor exercise training
8 weeks
3 visits per week (in-person)
Follow-up
Participants are monitored for changes in exercise tolerance and muscle blood flow
4 weeks
Treatment Details
Interventions
- Exercise training (Behavioural Intervention)
Trial OverviewThe study looks at how well patients with HFpEF respond to an 8-week exercise program compared to healthy people. The focus is on understanding why these patients struggle with exercise by measuring changes in muscle blood flow.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Exercise trainingExperimental Treatment1 Intervention
Patients with HFpEF will participate in the 8 weeks of supervised, two-legged, knee extensor exercise training for 3 days per week. Each exercise session will involve a 5-min warm-up and a 5-min cool-down, and exercise intensity will range between 40%-90% of maximal work rate. Maximal work rate will be re-assessed every two weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake City, UT
Loading ...
Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
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 in heart failure: inpatient and outpatient considerations. [2019]Exercise training has become increasingly important in the treatment of heart failure patients. It has long been known that the exercise tolerance of a patient with heart failure is related to his or her morbidity and mortality. Recently, it has been proved that exercise training improves cardiorespiratory function, functional status, and psychosocial status of heart failure patients. It is unknown whether these improvements will improve morbidity and mortality but quality of life appears to be enhanced. Subtle improvements in these areas may lead to a more satisfying and productive life for many heart failure patients. However, further investigation of the specific effects of such improvements is needed.
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.
...that exercise training is safe, useful and effective therapy and does not worsen cardiac function in heart failure? [2011]Exercise training in heart failure is safe, useful and effective therapy in the management of heart failure patients. Contrary to the old belief, it does not worsen cardiac function. Smaller studies also reported reduction in mortality and morbidity associated with exercise training. The available data support training HF patients to improve exercise tolerance and symptoms. Patients should be properly reviewed by their physicians prior to engaging in exercise training. It is highly recommended that patients be referred to a cardiac rehabilitation program, especially those with severe or advanced heart failure.
Experience from controlled trials of physical training in chronic heart failure. Protocol and patient factors in effectiveness in the improvement in exercise tolerance. European Heart Failure Training Group. [2022]Beneficial effects of physical training on exercise tolerance, autonomic and skeletal muscle function and limb blood flow have been demonstrated in chronic heart failure. Because this rehabilitation is expensive, may involve risk, and has unknown effects on prognosis, the possibility of predicting benefit on the basis of individual patient data is intriguing. The most suitable exercise training programme has not yet been established.
Exercise training in patients with heart failure: clinical outcomes, safety, and indications. [2021]Heart failure (HF) patients are often counseled to limit their physical activity, however, this advice may not be appropriate. Data has accumulated supporting the effectiveness of exercise training to improve fitness levels and symptoms. There are also data suggesting that training may reduce mortality and morbidity in HF patients. Studies have demonstrated that exercise training can be performed safely in appropriately evaluated HF patients. The literature would support the prescribing of exercise training to NYHA II-III HF patients. Consideration could also be given to training stable NYHA IV HF patients who are not symptomatic at rest. This article reviews the effects of exercise training on clinical outcomes and addressing the safety of exercise training and the indications for training in HF patients.
ExPAAC proceedings: Exercise training for individuals with heart failure. [2012]Heart failure (HF) is considered a condition primarily associated with the older population, with approximately 80% of individuals admitted to the hospital with a diagnosis of HF being over the age of 65 years. With the 'aging of the population' in the United States the incidence of HF is expected to continue to rise. Therefore many of the older individuals seen by physical therapists for an array of conditions will have HF as a primary diagnosis or comorbidity which needs to be addressed in developing their plan of care. Current evidence supports the safety and efficacy of exercise training as a component in the overall medical management of individuals with stable HF regardless of age. The primary aims of this article are to review the benefits associated with exercise training in individuals with HF and present the current recommendations for aerobic, resistance and inspiratory muscle exercise training along with recommendations for monitoring and modifying exercise training programs. Clinically, exercise training has been shown to have a significant effect on improving functional capacity, oxygen consumption, 6-minute walk test distances, symptoms, self-efficacy for exercise, and quality of life of individuals with HF. It is important that physical therapists adequately challenge individuals with HF with appropriate exercise intensities, while closely monitoring their patients, in order to achieve optimal functional benefits and quality of life.
[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.
Establishing a cardiac training group for patients with heart failure: the "HIP-in-Würzburg" study. [2022]Exercise training in heart failure (HF) is recommended but not routinely offered, because of logistic and safety-related reasons. In 2020, the German Society for Prevention&Rehabilitation and the German Society for Cardiology requested establishing dedicated "HF training groups." Here, we aimed to implement and evaluate the feasibility and safety of one of the first HF training groups in Germany.
Effects of Concurrent, Within-Session, Aerobic and Resistance Exercise Training on Functional Capacity and Muscle Performance in Elderly Male Patients with Chronic Heart Failure. [2023]The best format of exercise training (ET) in the setting of cardiac rehabilitation in patients with chronic heart failure (CHF) is still to be defined. Current guidelines recommend aerobic exercises, such as running and cycling, including some sessions per week of resistance exercise.
[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.