A Novel, Group-mediated Exercise Intervention With Remote Activity Monitoring in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
New exercise program for heart failure with preserved ejection fraction (HFpEF)
Plain English Summary
BOOST: Blended Onsite and Offsite Structured Exercise Training and Coaching is a Not Applicable clinical trial sponsored by Wake Forest University Health Sciences studying Heart Failure With Preserved Ejection Fraction. This study tests a new exercise program combined with remote monitoring for people with a specific type of heart failure called HFpEF. It is for individuals aged 55 and older who have HFpEF and experience symptoms like shortness of breath or fatigue. Participants will attend group exercise sessions and educational meetings, and use remote monitoring devices, for 12 weeks. Current treatments for HFpEF are limited, and this program aims to improve exercise capacity and quality of life. The trial aims to enroll 14 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 55 or older and have been diagnosed with HFpEF, showing symptoms and meeting specific heart function criteria. You cannot join if you have had recent heart events (like a heart attack or stroke), uncontrolled high blood pressure, severe lung disease, or certain heart conditions. You also cannot join if you have had significant changes in heart medication or HF symptoms recently, or if you are already exercising regularly. This trial is studying Heart Failure With Preserved Ejection Fraction, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure how confident patients feel about exercising and their perception of the benefits and barriers to exercise, indicating improvements in their ability and willingness to eng The specific primary outcome measures are: Exercise self-efficacy scales Scores (Baseline); Exercise self-efficacy scales Scores (Week 4); Exercise self-efficacy scales Scores (Week 12); Exercise Benefits/Barriers Scale Score (Baseline); Exercise Benefits/Barriers Scale Score (Week 4). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses a significant unmet need in heart failure treatment by developing a more accessible and potentially more effective exercise-based therapy for HFpEF, a growing public health concer This research targets Heart Failure With Preserved Ejection Fraction, where improved treatment options are needed.
Investor Insight
This trial focuses on a large and growing patient population with limited treatment options, suggesting a significant market potential for effective therapies; the novel blended approach could offer a
Is This Trial Right for Me?
Ask your doctor if this program is right for you, especially regarding your specific heart condition and exercise tolerance. Be prepared to attend group sessions twice a week for 12 weeks and use remote monitoring tools at home. Consider how you will manage travel to the study site and any potential conflicts with work or other commitments. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 14 participants
Interventions
- BEHAVIORAL: multi-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.
Primary Outcomes
- Exercise self-efficacy scales Scores (Baseline)
- Exercise self-efficacy scales Scores (Week 4)
- Exercise self-efficacy scales Scores (Week 12)
- Exercise Benefits/Barriers Scale Score (Baseline)
- Exercise Benefits/Barriers Scale Score (Week 4)
Full 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)
Trial Locations
- Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Frequently Asked Questions
What is clinical trial NCT07413198?
NCT07413198 is a Not Applicable INTERVENTIONAL study titled "BOOST: Blended Onsite and Offsite Structured Exercise Training and Coaching." It is currently not yet recruiting and is sponsored by Wake Forest University Health Sciences. The trial targets enrollment of 14 participants.
What conditions does NCT07413198 study?
This trial investigates treatments for Heart Failure With Preserved Ejection Fraction. The primary condition under study is Heart Failure With Preserved Ejection Fraction.
What treatments are being tested in NCT07413198?
The interventions being studied include: multi-domain behavioral, coaching, and exercise protocol (BEHAVIORAL). 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.
What does Not Applicable mean for NCT07413198?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07413198?
This trial is currently "Not Yet Recruiting." It started on 2026-05. The estimated completion date is 2027-03.
Who is sponsoring NCT07413198?
NCT07413198 is sponsored by Wake Forest University Health Sciences. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07413198?
The trial aims to enroll 14 participants. The trial has not yet started recruiting.
How is NCT07413198 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT07413198?
The primary outcome measures are: Exercise self-efficacy scales Scores (Baseline); Exercise self-efficacy scales Scores (Week 4); Exercise self-efficacy scales Scores (Week 12); Exercise Benefits/Barriers Scale Score (Baseline); Exercise Benefits/Barriers Scale Score (Week 4). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07413198 being conducted?
This trial is being conducted at 1 site, including Winston-Salem, North Carolina (United States).
Where can I find official information about NCT07413198?
The official record for NCT07413198 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07413198. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07413198 testing in simple terms?
This study tests a new exercise program combined with remote monitoring for people with a specific type of heart failure called HFpEF. It is for individuals aged 55 and older who have HFpEF and experience symptoms like shortness of breath or fatigue.
Why is this trial significant?
This trial addresses a significant unmet need in heart failure treatment by developing a more accessible and potentially more effective exercise-based therapy for HFpEF, a growing public health concer
What are the potential risks of participating in NCT07413198?
Potential risks include chest pain, shortness of breath, or fatigue during exercise, which should be reported immediately. Side effects may include muscle soreness or discomfort from physical activity. There is a small risk of cardiac events during exercise, though participants are carefully screened and monitored. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07413198?
Ask your doctor if this program is right for you, especially regarding your specific heart condition and exercise tolerance. Be prepared to attend group sessions twice a week for 12 weeks and use remote monitoring tools at home. Consider how you will manage travel to the study site and any potential conflicts with work or other commitments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07413198 signal from an investment perspective?
This trial focuses on a large and growing patient population with limited treatment options, suggesting a significant market potential for effective therapies; the novel blended approach could offer a This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will attend group exercise sessions and educational meetings, and use remote monitoring devices, for 12 weeks. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.