Recruiting

Supervised Exercise Training

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07413198

Conditions

Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

multi-domain behavioral, coaching, and exercise protocol

Study Details

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

Study ID

NCT07413198

Start date

May 5, 2026

Status verified date

May, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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 Design

Enrollment

14 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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 outcome measure

  • Exercise self-efficacy scales Scores [ Time Frame: Baseline ]
  • Exercise self-efficacy scales Scores [ Time Frame: Week 4 ]
  • Exercise self-efficacy scales Scores [ Time Frame: Week 12 ]
  • Exercise Benefits/Barriers Scale Score [ Time Frame: Baseline ]
  • Exercise Benefits/Barriers Scale Score [ Time Frame: Week 4 ]
  • Exercise Benefits/Barriers Scale Score [ Time Frame: Week 12 ]
  • Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores [ Time Frame: Baseline ]
  • Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores [ Time Frame: Week 4 ]
  • Heart Failure quality-of-life assessment - Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores [ Time Frame: Week 12 ]
  • Number of daily steps by accelerometer [ Time Frame: Baseline ]
  • Number of daily steps by accelerometer [ Time Frame: Week 4 ]
  • Number of daily steps by accelerometer [ Time Frame: Week 12 ]
  • 6-minute walk distance [ Time Frame: Baseline ]
  • 6-minute walk distance [ Time Frame: Week 4 ]
  • 6-minute walk distance [ Time Frame: Week 12 ]
  • The Short Physical Performance Battery (SPPB) Score [ Time Frame: Baseline ]
  • The Short Physical Performance Battery (SPPB) Score [ Time Frame: Week 4 ]
  • The Short Physical Performance Battery (SPPB) Score [ Time Frame: Week 12 ]
  • Grip strength [ Time Frame: Baseline ]
  • Grip strength [ Time Frame: Week 4 ]
  • Grip strength [ Time Frame: Week 12 ]
  • Cardiopulmonary Exercise Testing (CPET) [ Time Frame: Baseline ]
  • Cardiopulmonary Exercise Testing (CPET) [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Anthony E Peters, MD

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

Kimberly Kennedy, MS

336.713.8567Kimberly.Kennedy@Advocatehealth.org

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Anthony E Peters, MD

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

Kimberly Kennedy, MS

336.713.8567Kimberly.Kennedy@Advocatehealth.org

Principal Investigator:

Anthony E Peters, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • Heart failure
  • Supervised exercise training
  • Group-based exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-05-26.