BOOST: Blended Onsite and Offsite Structured Exercise Training and Coaching

Official title

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

Overview

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.

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.

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 outcome measures

• 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]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT07413198 · IRB00142040 · 00000132 · P30AG021332

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗