BOOST: Blended Onsite and Offsite Structured Exercise Training and Coaching
A Novel, Group-mediated Exercise Intervention With Remote Activity Monitoring in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 55 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests new ways to improve supervised exercise training and coaching, using sessions both at and away from the study site. It is for adults age 55 or older with HFpEF, a type of heart failure in which the heart still pumps a normal share of blood.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 55 or older.
- Heart failure symptoms and at least one of these: high pressure as the heart fills, a past hospital stay for heart failure, or a high score on tests used to identify HFpEF.
- The heart’s main pumping chamber pumps out at least 50% of its blood with each beat.
- Heart failure that limits physical activity or causes symptoms at rest (NYHA class II–IV).
Who can't join
- Major changes in heart medicines or heart failure symptoms in the past 3 weeks, or a hospital or urgent care visit for heart failure in the past 4 weeks.
- A recent sudden heart blood-flow problem, stroke, mini-stroke, major heart or blood vessel surgery, or procedure to open heart or neck arteries within 30 days; or a recent or disabling stroke.
- Uncontrolled high blood pressure, severe lung disease, or low hemoglobin—the blood protein that carries oxygen—within 30 days: below 9.5 g/dL for men or 9 g/dL for women.
- A past heart transplant, a heart pump device (LVAD), being on the transplant list, or major heart valve disease that has not been repaired.
- Certain heart conditions: a tight sac around the heart, inherited thick heart muscle, abnormal material building up in heart muscle, or life-threatening or uncontrolled heart rhythms.
- A treadmill test showing low blood flow to the heart, chest pain, leg pain from poor blood flow, unstable blood pressure or heart rhythm, or blood pressure above 240 systolic or 110 diastolic; or being unable or unwilling to finish an adequate test.
- Already doing moderate to hard exercise for more than 30 minutes a day, at least twice a week, regularly over the past 6 weeks.
- A non-heart illness with expected survival under 12 months; any condition the study doctor believes prevents participation; or being unable to meet study demands because of travel distance, work, or other conflicts.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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)
Study sites (1)
NC
- Wake Forest University Health Sciences · Winston-Salem, NC 27157Anthony E Peters, MD · Study contact · 336-713-2278 · Anthony.Peters@advocatehealth.orgKimberly Kennedy, MS · Study contact · 336.713.8567 · Kimberly.Kennedy@Advocatehealth.orgAnthony E Peters, MD · Principal investigatorMore trials in Winston-Salem