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Heart Failure With Preserved Ejection FractionHFpEFNCT07413198

BOOST: Blended Onsite and Offsite Structured Exercise Training and Coaching

A study testing multi-domain behavioral, coaching, and exercise protocol in people with Heart Failure With Preserved Ejection Fraction, run by Wake Forest University Health Sciences at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
multi-domain behavioral, coaching, and exercise protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
5 May 2026to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 16Show fewer
  • 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 and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Anthony E Peters, MD, 336-713-2278, Anthony.Peters@advocatehealth.org

    Kimberly Kennedy, MS, 336.713.8567, Kimberly.Kennedy@Advocatehealth.org

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
multi-domain behavioral, coaching, and exercise protocol
Keywords
Heart failure, Supervised exercise training, Group-based exercise
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multi-domain behavioral, coaching, and exercise protocolBehavioural

    Also called behavioral, coaching, and exercise

    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.

Study groups in NCT07413198
Study groupRoleWhat they receive
multi-domain behavioral, coaching, and exercise protocolExperimentalA 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.
Receives: Behavioral: multi-domain behavioral, coaching, and exercise protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Week 4

  3. 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.

    Measured: Week 12

  4. Exercise Benefits/Barriers Scale Score

    Evaluates how participants determine benefits of and barriers to participating in exercise.

    Measured: Baseline

  5. Exercise Benefits/Barriers Scale Score

    Evaluates how participants determine benefits of and barriers to participating in exercise.

    Measured: Week 4

  6. Exercise Benefits/Barriers Scale Score

    Evaluates how participants determine benefits of and barriers to participating in exercise.

    Measured: Week 12

  7. Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores

    scores from 0-100, where higher scores indicate better health

    Measured: Baseline

  8. Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores

    scores from 0-100, where higher scores indicate better health

    Measured: Week 4

  9. Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores

    scores from 0-100, where higher scores indicate better health

    Measured: Week 12

  10. Number of daily steps by accelerometer

    Number of daily steps recorded for 1 week

    Measured: Baseline

  11. Number of daily steps by accelerometer

    Number of daily steps recorded for 1 week

    Measured: Week 4

  12. Number of daily steps by accelerometer

    Number of daily steps recorded for 1 week

    Measured: Week 12

  13. 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.

    Measured: Baseline

  14. 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.

    Measured: Week 4

  15. 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.

    Measured: Week 12

  16. 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).

    Measured: Baseline

  17. 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).

    Measured: Week 4

  18. 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).

    Measured: Week 12

  19. 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.

    Measured: Baseline

  20. 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.

    Measured: Week 4

  21. 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.

    Measured: Week 12

  22. 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.

    Measured: Baseline

  23. 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.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start5 May 2026
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07413198
Sponsor's protocol ID
IRB00142040
Other IDs
00000132, P30AG021332
Acronym
HFpEF
Status last verified
May 2026
First submitted
9 Feb 2026
Last updated
26 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing multi-domain behavioral, coaching, and exercise protocol in people with Heart Failure With Preserved Ejection Fraction, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anthony E Peters, MD (336-713-2278, Anthony.Peters@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise self-efficacy scales Scores (time frame: Baseline). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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