Abstract

Background: Heart failure with preserved ejection fraction (HFpEF) remains a challenge in cardiovascular care. A chief complaint in adults with HFpEF is fatigue, and regular exercise training is the only treatment shown to routinely improve this symptom. Adherence to exercise recommendations is difficult. We significantly improved 12-month adherence to exercise in adults with persistent HF using an in-person coaching intervention. Secondary analysis of our HFpEF subgroup showed promising long-term exercise adherence. These findings support our recently funded trial to test an intervention delivered in-person vs. virtually to achieve long-term exercise adherence in adults with HFpEF. Aims: We will: 1) Evaluate effects of in-person vs. virtual coaching and enhanced usual care on 12- and 18-month exercise adherence, 2) Determine the optimal minutes of moderate-intensity exercise that yields clinically meaningful change in patient-reported outcomes, 3) Evaluate interventional mechanisms and interim clinical events as mediators of adherence behaviors, and (4) Examine the cost of intervention delivery. Approach: This multi-site, 3-group randomized controlled trial will recruit 300 adults with stable HFpEF to compare an in-person coaching intervention to a virtual coaching, and both to enhanced usual care (UC). After a run-in period, all participants receive a medical fitness center membership (in-person or virtual) for 18 months and are randomized following a 2-2-1 strategy to in-person coaching and exercise (n=120), virtual coaching and exercise (n=120) or UC virtual exercise only (n=60). The primary outcome is adherence to ≥120 minutes of exercise/week measured using a heart rate monitor at 12 months, with a sustainability endpoint at 18 months. Secondary outcomes include health status, physical function and activity, HFpEF symptoms, and inflammatory biomarkers. Data are collected at baseline, 6, 12, and 18 months. Conclusions: Our findings will guide selection of the most efficacious and cost-effective delivery approaches to promote exercise adherence. Identifying active interventional mechanisms and the dose of exercise needed to elicit a response will help to achieve a clinically meaningful change in patient-reported outcomes in HFpEF.

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