Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
Heart failure, Supervised exercise training, Group-based exercise
Brief summary
Heart failure with preserved ejection fraction (HFpEF) represents a major public health burden that is both growing rapidly and has few effective therapies. Supervised exercise training (SET) is one of the few effective therapies for older patients with HFpEF, but is currently constrained by cost, resource limitations, and sub-optimal short and long-term clinical response. The objective is to develop and test novel strategies to augment the therapy of exercise training to optimize response and resource utilization in older patients with HFpEF.
Detailed description
The hypothesis is that enhancing Supervised exercise training (SET) with a group-mediated behavioral approach and remote activity-monitoring will enable more robust behavioral changes in physical activity at lower cost. To test this hypothesis, the study will recruit patients with Heart failure with preserved ejection fraction (HFpEF) and assign to 2 sequential groups/waves for trainer-guided, aerobic-based exercise and group counseling sessions, with iterative refinements between waves.
Interventions
BEHAVIORALmulti-domain behavioral, coaching, and exercise protocol
Group-mediated educational sessions, individual coaching contacts, group exercise sessions, and home-based self-guided exercise - Groups will engage in this iterative, trainer-guided, in-person, aerobic-based exercise and group counseling sessions approximately 2 times/week for 12 weeks.
Sponsors
Wake Forest University Health Sciences
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
older patients with Heart Failure with Preserved Ejection Fraction (HFpEF) will be assigned to 2 sequential groups/waves for trainer-guided, aerobic-based exercise and group counseling sessions, with iterative refinements between waves.
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of heart failure with signs and symptoms of heart failure and at least one of the following: Evidence of increased LV filling pressures at rest, exercise, or other provocations / Prior HF hospitalization / Elevated heart Failure with Preserved Ejection Fraction (H2FPEF) score or elevated Heart Failure Association-Pre-test, Echocardiography \& natriuretic peptide, Functional testing, Final etiology (HFA-PEFF) score * Left ventricular ejection fraction ≥ 50% * New York Heart Association (NYHA) functional class II-IV * Age ≥ 55 years old
Exclusion criteria
* Significant change in cardiac medication or heart failure (HF) symptoms within 3 weeks prior to enrollment * Hospitalization or urgent care visit for HF within 4 weeks prior to enrollment * Acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other major Cardiac Vascular (CV) surgery; percutaneous coronary intervention (PCI) or carotid angioplasty, within 30 days prior to enrolment * Uncontrolled hypertension * Recent or debilitating stroke * Severe pulmonary disease including chronic obstructive pulmonary disease (COPD) * Hemoglobin (Hgb) \< 9.5 g/dL males and \< 9 g/dL females within 30 days prior to enrollment * Patients with a history of heart transplant or Left Ventricular Assist Device (LVAD), currently on the transplant list * Significant, unrepaired cardiac valvular disease * A non-cardiac medical condition with an estimated life expectancy of \< 12 months * Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloid heart disease (amyloidosis) * Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter * A treadmill exercise test revealing: ischemia; chest pain or leg claudication; exercise Systolic Blood Pressure \> 240 mmHg, Diastolic Blood Pressure \> 110 mmHg; unstable hemodynamics or rhythm; or unwilling or unable to complete adequate exercise test * Already engaging in regular moderate to vigorous exercise conditioning defined as \>30 minutes per day, ≥twice per week consistently during the previous 6 weeks * Any condition that in the judgement of the investigator precludes participation in study or study procedures such as significant dementia, mobility impairment, uncontrolled psychiatric disease, etc. * Inability to meet the expectations of the intervention (i.e., excessive distance from facility, work conflict with intervention)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise self-efficacy scales Scores | Baseline | Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise. |
| Exercise Benefits/Barriers Scale Score | Baseline | Evaluates how participants determine benefits of and barriers to participating in exercise. |
| Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores | Baseline | scores from 0-100, where higher scores indicate better health |
| Number of daily steps by accelerometer | Baseline | Number of daily steps recorded for 1 week |
| 6-minute walk distance | Baseline | measures functional capacity by the distance walked in 6 minutes, indicating disease severity, prognosis, and treatment response, especially in cardiopulmonary conditions like COPD or heart failure shorter distances (e.g., \<350m) often signaling higher mortality risk, while significant changes (e.g., \>50m) suggest clinical improvement or decline, though interpretation always needs clinical context and comparison to age/gender norms. |
| The Short Physical Performance Battery (SPPB) Score | Baseline | The SPPB is a measure of physical function that incorporates three components: usual gait speed measured over 4 meters, timed repeated chair rise, and standing balance with progressively narrow base of support. Each component is scored on a 0-4 scale and then summed to provide an overall score range of 0-12 - scores ranging from 0 (worst) to 12 (best). |
| Grip strength | Baseline | Low handgrip strength, a key indicator in sarcopenia, is often defined as \<28 kg for men and \<18 kg for women (based on AWGS19) or even lower, depending on the study, such as \<26 kg and \<16 kg. |
| Cardiopulmonary Exercise Testing (CPET) | Baseline | Evaluates how your heart, lungs, and muscles work together during physical exertion, using a treadmill or bike while monitoring breathing (mask), heart activity (ECG), and vitals (blood pressure) to diagnose causes of shortness of breath, assess heart/lung conditions like heart failure or Chronic Obstructive Pulmonary Disease (COPD), and determine exercise capacity, offering a comprehensive view of cardiovascular and respiratory fitness. Normal values typically range from 35 to 40 mL/kg/min for healthy middle-aged individuals, with variations based on age, sex, and training status. |
Countries
United States
Contacts
CONTACTAnthony E Peters, MD
CONTACTKimberly Kennedy, MS
PRINCIPAL_INVESTIGATORAnthony E Peters, MD
Wake Forest University Health Sciences
Outcome results
None listed