Exercise Program for Heart Failure
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Virginia
Disqualifiers: Uncontrolled diabetes, Severe aortic stenosis, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study is trying to find out whether performing a hybrid aerobic-resistance exercise training program (titled PRIME: Peripheral Remodeling via Intermittent Muscular Exercise) results in better health outcomes than the traditional exercise training program (called COMBO) that is used in individuals with heart failure with reduced ejection fraction (HFrEF). Participants will be randomized (like the flip of a coin) to either PRIME (investigational) or the traditional exercise program (standard of care).
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 COMBO, Traditional Exercise Training Program, Standard of Care Exercise Program, PRIME, Peripheral Remodeling via Intermittent Muscular Exercise for heart failure?
Research shows that exercise training is safe and improves health status and exercise capacity in heart failure patients, helping to reduce abnormal changes in the body caused by the condition. Additionally, peripheral muscle training can lead to significant muscle adaptation with minimal stress on the heart, which may benefit heart failure patients who cannot engage in traditional exercise.
12345Is exercise training safe for people with heart failure?
Exercise training is generally safe for people with heart failure, as studies have shown it improves health status and exercise capacity, and reduces some of the negative effects of heart failure.
26789How does the exercise program for heart failure differ from other treatments?
This exercise program for heart failure is unique because it combines moderate-intensity aerobic and resistance training, and includes a preliminary phase called Peripheral Remodeling through Intermittent Muscular Exercise (PRIME) to enhance aerobic capacity and muscle strength more effectively than traditional exercise programs.
710111213Eligibility Criteria
This trial is for individuals over 65 with heart failure and reduced ejection fraction (HFrEF), specifically those who can communicate well, have cardiologist approval, and a hemoglobin level of at least 10.0 g/dL. It's not for people with uncontrolled diabetes, recent heart attacks or embolism, severe valve disease needing surgery, new atrial fibrillation, worsening symptoms in the past few days, significant ischemia during low exercise levels, or certain other acute conditions.Inclusion Criteria
My cardiologist has approved my participation after reviewing my medical records and examining me.
I can understand and communicate about the study, and I can legally consent.
Your hemoglobin level must be at least 10.0 grams per deciliter.
+2 more
Exclusion Criteria
I have not had a blood clot in the last 6 weeks.
I have severe narrowing of my aortic valve.
I need surgery for a heart valve problem causing backflow.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Phase 1: Treatment
Participants undergo 4 weeks of either PRIME or COMBO exercise training
4 weeks
Phase 2: Treatment
All participants undergo 8 weeks of progressive whole-body COMBO training
8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Participant Groups
The study compares a novel exercise program called PRIME against the traditional COMBO exercise regimen to see which one leads to better health outcomes for older patients with HFrEF. Participants will be randomly assigned to either the investigational PRIME program or the standard COMBO training.
2Treatment groups
Experimental Treatment
Group I: PRIME + COMBOExperimental Treatment2 Interventions
PRIME training (Phase 1), followed by 8 weeks of progressive whole-body COMBO training.
Group II: COMBO onlyExperimental Treatment1 Intervention
4 weeks of standard progressive whole-body aerobic plus resistance training (COMBO) followed by 8 weeks continued COMBO training.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Virginia, Department of KinesiologyCharlottesville, VA
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Who Is Running the Clinical Trial?
University of VirginiaLead Sponsor
National Institute on Aging (NIA)Collaborator
National Institutes of Health (NIH)Collaborator
References
Adaptation to peripheral muscle training. [2008]Ten healthy subjects underwent a 6-week dynamic exercise program designed to put a high relative load on individual muscle groups while maintaining low central circulatory stress levels. This was done to test the hypothesis that such "peripheral" training could produce skeletal muscle adaptation at low levels of myocardial work. Such a program may be useful in rehabilitating patients whose myocardial disease prevents adequate levels of participation in the traditional types of large muscle training. Strength testing, muscle biopsies and both submaximal and maximal bicycle ergometry were done to assess the effects of "peripheral" training. Heart rate during the training sessions decreased progressively over the 6 weeks (p less than 0.001). Quadriceps strength increased (p less than 0.02) with training as did both quadriceps (p less than 0.03) and gastrocnemius (p less than 0.008) fiber areas. Fiber composition was unchanged. Succinic dehydrogenase concentrations were unchanged while phosphorylase activity decreased in both muscle groups (p less than 0.03). Submaximum and maximum bicycle ergometry results were unchanged with training. The data show that dynamic training of small groups of muscles sequentially can produce significant skeletal muscle adaptation with little central circulatory stress. The effects of "peripheral" training in cardiac patients remain to be determined.
Role and benefits of exercise in the management of patients with heart failure. [2021]Initial research established the feasibility of exercise training in patients with heart failure, as well as associated physiological benefits. This review summarizes the findings from over two dozen single-site studies that address the effect of exercise training on exercise capacity and cardiovascular and peripheral function. In addition, it incorporates the results from two meta-analyses and a recently completed multi-center trial, all of which studied the effects of exercise training on clinical outcomes. The major conclusions from these studies are that exercise training is safe; improves health status and exercise capacity; helps attenuate much of the abnormal pathophysiology that develops with heart failure; and yields a modest reduction in clinical events. The magnitude of the clinical benefits appears related to the volume of exercise completed. Future research is needed to identify which patient subgroups might benefit the most from exercise training, the optimal exercise dose or load needed to lessen disease-related symptoms and maximize clinical benefit, and the effects of exercise training in patients with heart failure and preserved left ventricular systolic function.
Exercise physiology in cardiovascular diseases. [2019]Exercise testing protocols and training regimens are well established for patients recovering from myocardial infarction or coronary artery bypass surgery. However, exercise rehabilitation programs for patients with peripheral arterial disease or left ventricular dysfunction with congestive heart failure have not been well developed. Several recent reports have established reproducible exercise testing protocols with objective measures of performance for patients with peripheral arterial disease and congestive heart failure. Using these testing methods to define changes in exercise capacity, exercise training programs have been shown to result in a significant increase in exercise performance and community-based quality of life. The mechanism of improvement appears to involve peripheral adaptations in skeletal muscle metabolism rather than increases in cardiac output or peripheral blood flow.
Intermittent versus continuous exercise training in chronic heart failure: a meta-analysis. [2022]We conducted a meta-analysis of randomized, controlled trials of combined strength and intermittent aerobic training, intermittent aerobic training only and continuous exercise training in heart failure patients.
[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.
Impaired Exercise Tolerance in Heart Failure: Role of Skeletal Muscle Morphology and Function. [2022]To discuss the impact of deleterious changes in skeletal muscle morphology and function on exercise intolerance in patients with heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF), as well as the utility of exercise training and the potential of novel treatment strategies to preserve or improve skeletal muscle morphology and function.
PRIME-HF: Novel Exercise for Older Patients with Heart Failure. A Pilot Randomized Controlled Study. [2023]To test the hypothesis that (1) older patients with heart failure (HF) can tolerate COMBined moderate-intensity aerobic and resistance training (COMBO), and (2) 4 weeks of Peripheral Remodeling through Intermittent Muscular Exercise (PRIME) before 4 weeks of COMBO will improve aerobic capacity and muscle strength to a greater extent than 8 weeks of COMBO.
Exercise and heart failure. [2007]This report will review the abnormalities of the peripheral circulation and skeletal muscle which are part of the heart failure syndrome and can limit exercise tolerance; introduce trials that have shown benefits of exercise training in a variety of heart failure patients; suggest strategies for recommending activity training in patients with heart failure. Finally, this report will identify areas where data are missing and where trials are currently being undertaken.
Effects of aerobic and inspiratory training on skeletal muscle microRNA-1 and downstream-associated pathways in patients with heart failure. [2021]The exercise intolerance in chronic heart failure with reduced ejection fraction (HFrEF) is mostly attributed to alterations in skeletal muscle. However, the mechanisms underlying the skeletal myopathy in patients with HFrEF are not completely understood. We hypothesized that (i) aerobic exercise training (AET) and inspiratory muscle training (IMT) would change skeletal muscle microRNA-1 expression and downstream-associated pathways in patients with HFrEF and (ii) AET and IMT would increase leg blood flow (LBF), functional capacity, and quality of life in these patients.
[Special aspects of physical training during the rehabilitation stage of coronary patients]. [2007]Practical aspects: Physical exercise is a basic component of the rehabilitation program for patients recuperating from myocardial infarction or bypass surgery. The aim of exercise is to enhance physical performance by improving coordination, flexibility, strength, speed and endurance. The training concept is matched to the individual capability, which is determined by an exercise test at the beginning of the rehabilitation program. On the basis of this test, an "exercise heart rate" is calculated with the aim of protecting the patient from overstrenuous activity. Depending on their physical fitness, the patients are divided into two groups: those with a capability of less, and those with a capability of more than 1 watt/kg. Most elderly patients are no longer active participants in sports, so that guidance through flexibility and coordination exercise is offered. Usually, patients perform a daily program of 15 minutes of physical activity in their individual groups, and spend 45 minutes walking and relaxing. In addition, they have opportunities for swimming, jogging and cycling. Decreased left-ventricular function: The effects of a four-week training program in myocardial infarction (MI) patients with moderate-to-severe left-ventricular dysfunction were investigated in two distinct studies. In neither study was a deterioration in the ejection fraction at rest or during exercise observed. In the second study, an additional parameter was provided by the Swan-Ganz catheter. Neither pulmonary wedge pressure (PWP) nor cardiac output indicated any deterioration in response to dosed training. However, in this second study, four patients in the training group with a resting ejection fraction (EF) less than 30% developed complications. All these patients had a pathological PWP at rest. Nevertheless, five patients with an EF less than 30% but with a normal PWP at rest completed the training program without complications. The long-term prognosis for training post-MI patients with severe left-ventricular dysfunction would appear to be no worse than for controls. Results of the first study: During the four-week training program, no complications occurred. No major changes in the EF at rest and during training were seen. In the training group the EF at rest increased slightly to 40 +/- 10%. The EF during exercise improved to 39 +/- 10%. Delta EF showed a decrease of 3 +/- 8%. After the four-week training period the decrease was 1 +/- 9%. In the control group, a major increase in the EF at rest to 41 +/- 10% was seen. The EF during exercise, however, showed only a small increase to 43 +/- 15%.(ABSTRACT TRUNCATED AT 400 WORDS)
[Exercise training improves activities of daily living in elderly patients with congestive heart failure]. [2019]Exercise training which is one of the multidisciplinary interventions for elderly patients with congestive heart failure, plays an important role for improving the quality of life and reducing the re-admission rate of these patients. We assessed the validity of exercise training for the improvement of patient's skeletal muscle functions and activities of daily living along with monitoring cardiac functions. Exercise training programs were performed in 12 patients with congestive heart failure (New York Heart Association class III or IV), including 5 with valvular disease, 4 with dilated cardiomyopathy and 3 with ischemic cardiomyopathy (mean 79 +/- 9 years). All patients were admitted because of exacerbation of congestive heart failure and were treated conventionally. The exercise training program was started after stabilization of their cardiac condition. The medication was not changed during the training period. After exercise training programs, the cardio-thoracic ratio decreased from 63.8 +/- 7.9% to 60.1 +/- 6.9% (p
Effects of machine-assisted cycling on exercise capacity and endothelial function in elderly patients with heart failure. [2019]Conventional exercise training (ET) for elderly patients with heart failure (HF) includes low-intensity stretching and gait training. The effects of 2 types of low-intensity ET - machine-assisted cycling and conventional ET - on exercise capacity and endothelial function of elderly patients with HF was investigated in the present study.
Benefits of exercise training in the treatment of heart failure: study with a control group. [2022]Exercise training programs have been proposed as adjuncts to treatment of heart failure. The effects of a 3-month-exercise-training-program with 3 exercise sessions per week were assessed in patients with stable systolic chronic heart failure.