BOOST: Blended Onsite and Offsite Structured Exercise Training and Coaching (HFpEF)

A Novel, Group-mediated Exercise Intervention With Remote Activity Monitoring in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Behavioral: multi-domain behavioral, coaching, and exercise protocol

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.

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anthony E Peters, MD; Phone Number: 336-713-2278; Email: Anthony.Peters@advocatehealth.org
• Study Contact Backup: Name: Kimberly Kennedy, MS; Phone Number: 336.713.8567; Email: Kimberly.Kennedy@Advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Anthony E Peters, MD; Phone Number: 336-713-2278; Email: Anthony.Peters@advocatehealth.org
      • Contact: Kimberly Kennedy, MS; Phone Number: 336.713.8567; Email: Kimberly.Kennedy@Advocatehealth.org
      • Principal Investigator: Anthony E Peters, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: multi-domain behavioral, coaching, and exercise protocol; A non-randomized, single-arm, iterative refinement pilot study. The study will recruit older patients with Heart Failure with Preserved Ejection Fraction (HFpEF) and assign them to 2 sequential groups/waves for trainer-guided, aerobic-based exercise and group counseling sessions, with iterative refinements between waves.

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.; Other Names: behavioral, coaching, and exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise self-efficacy scales Scores	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.	Baseline
Exercise self-efficacy scales Scores	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.	Week 4
Exercise self-efficacy scales Scores	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.	Week 12
Exercise Benefits/Barriers Scale Score	Evaluates how participants determine benefits of and barriers to participating in exercise.	Baseline
Exercise Benefits/Barriers Scale Score	Evaluates how participants determine benefits of and barriers to participating in exercise.	Week 4
Exercise Benefits/Barriers Scale Score	Evaluates how participants determine benefits of and barriers to participating in exercise.	Week 12
Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores	scores from 0-100, where higher scores indicate better health	Baseline
Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores	scores from 0-100, where higher scores indicate better health	Week 4
Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores	scores from 0-100, where higher scores indicate better health	Week 12
Number of daily steps by accelerometer	Number of daily steps recorded for 1 week	Baseline
Number of daily steps by accelerometer	Number of daily steps recorded for 1 week	Week 4
Number of daily steps by accelerometer	Number of daily steps recorded for 1 week	Week 12
6-minute walk distance	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.	Baseline
6-minute walk distance	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.	Week 4
6-minute walk distance	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.	Week 12
The Short Physical Performance Battery (SPPB) Score	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).	Baseline
The Short Physical Performance Battery (SPPB) Score	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).	Week 4
The Short Physical Performance Battery (SPPB) Score	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).	Week 12
Grip strength	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.	Baseline
Grip strength	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.	Week 4
Grip strength	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.	Week 12
Cardiopulmonary Exercise Testing (CPET)	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.	Baseline
Cardiopulmonary Exercise Testing (CPET)	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.	Week 12

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Anthony E Peters, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Heart failure; Supervised exercise training; Group-based exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: IRB00142040; P30AG021332 (U.S. NIH Grant/Contract); 00000132 (Other Identifier: National Institute on Aging)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No