Personalized remotely guided preventive exercise therapy for a healthy heart: protocol and design of the PRIORITY study

Abstract

Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Research Foundation – Flanders (FWO) Introduction Approximately half of the heart failure population has heart failure with preserved ejection fraction (HFpEF), a chronic disease starting with cardiovascular risk factors such as hypertension, diabetes and obesity (stage A) which can further emerge in a structural heart disease without (stage B) or with (stage C) signs or symptoms. Structured exercise therapy is recommended as a Class IA intervention in national and international guidelines and, as such, should be offered to all patients. Yet, in current practice, exercise therapy is often only offered within a secondary prevention program. At present, there exists no comprehensive preventive care program that includes structured exercise for patients in the early stages of heart failure, when cardiovascular risk factors are present, but cardiac remodeling and dysfunction might still be reversible or even preventable. Purpose PRIORITY aims to investigate the use of remotely guided exercise therapy as a preventive clinical and cost-effective treatment in the HFpEF continuum. This includes both prevention of progression of asymptomatic diastolic dysfunction towards symptomatic HFpEF (= primary prevention) and delaying progression of symptomatic HFpEF (= secondary prevention). Methods A randomized controlled multicenter trial will be conducted in 450 patients (men and women, aged 35-80 years) with heart failure (n = 180 stage A, 180 stage B, 90 stage C). Participants are being recruited from 3 different hospitals and the general population during a 16-month period which started in September 2021. Patients will be randomized (1:1) to usual care or to the PRIORITY exercise intervention (i.e. a combination of supervised with remotely guided home-based training sessions). Training prescription is based on the EXPERT tool and includes person-tailored endurance and dynamic strength training. During one year, participants will receive 18 supervised exercise sessions supplemented with a structured progressive home-based exercise program. Outcomes will be assessed at baseline, 4 months, one and two-years. Primary outcome is the proportion of patients with a clinically relevant improvement in peak oxygen uptake at one-year. Secondary outcomes include vascular health, muscle metabolism, change in electrocardiographic parameters and physical fitness parameters (muscle strength, body composition). Further, big data of physical activity collected during the trial will be used to develop models using machine-learning algorithms which can predict physical activity uptake and changes in fitness to facilitate the creation of more personalized interventions and better tailored exercise prescription. Conclusion We anticipate that the PRIORITY study will contribute to better prevention of heart failure thanks to an early easily accessible person-tailored exercise intervention.