BOOST: Blended Onsite and Offsite Structured Exercise Training and Coaching

NCT07413198 | Not Yet Recruiting DMC

• 3 other identifiers: IRB0014204000000132P30AG021332
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

Heart failure; Supervised exercise training; Group-based exercise

Outcome Measures

Primary Outcomes (23)

• 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

Study Arms (1)

multi-domain behavioral, coaching, and exercise protocol

EXPERIMENTAL

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

Interventions

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.

Also known as: behavioral, coaching, and exercise

multi-domain behavioral, coaching, and exercise protocol

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anthony E Peters, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony E Peters, MD

CONTACT

336-713-2278; Anthony.Peters@advocatehealth.org

Kimberly Kennedy, MS

CONTACT

336.713.8567; Kimberly.Kennedy@Advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)