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.
Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): FWO - Research Foundation – Flanders. Background Exercise is a key therapy for patients across all the stages of heart failure with preserved ejection fraction (HFpEF). Despite being a class I recommendation, the EUROASPIRE registry showed that only a third of patients is sufficiently active, with numbers being even lower among patients with symptomatic HFpEF (stage C). Knowledge of barriers and confidence to exercise is needed to increase the uptake of exercise and a physically active lifestyle. Objective To assess barriers to exercise and self-efficacy in patients along the continuum of HFpEF and to detect possible differences between patients in different HFpEF stages. Methods The first 60 patients (n = 20 HFpEF stage A, 20 HFpEF stage B, 20 HFpEF stage C) from the PRIORITY randomized controlled trial (PeRsonalIzed remOtely guided preventive exeRcIse therapy for a healThY heart) were included. Barriers to exercise and self-efficacy were evaluated using the Exercise Barrier Questionnaire and the Exercise Self-Efficacy Scale. Results Patients with HFpEF stage C were older (72 ± 9.41 years), more likely to be female (70%) and were less physically fit (peak VO2 14.09 ± 2.58 ml/min/kg) compared to patients with HFpEF stage A (63.5 ± 9.10 years, 40% women and peak VO2 21.43 ± 4.94 ml/min/kg) and stage B (70.5 ± 5.25 years, 40% women and peak VO2 17.84 ± 5.15 ml/min/kg). As shown in Figure 1, patients with HFpEF stage C reported more barriers to exercise compared to patients with HFpEF stage A or HFpEF stage B. In particular, 50% of HFpEF stage C reported that they would not exercise when they perceived the exercise as boring (vs A:21%, B:22%), not fun (vs A: 21%, B:21%), if supervised by a bad instructor (vs A:32%, B:33%) or during holidays (vs A:26%, B:17%). Almost 40% of patients with HFpEF stage C reported that having to exercise alone would be a barrier for them (vs A:11%, B:22%). As shown in Figure 2, patients with HFpEF stage C were less confident that they 1) could overcome barriers to exercise by finding appropriate exercise resources (A:0%, B:6%, C:11%), 2) would exercise when feeling tired (A:5%, B:24%, C:28%), 3) would exercise without family support (A:5%, B:6%, C: 17%) or 4) without professional support (A:11%, B:18%, C:17%). Conclusion Barriers to exercise and self-efficacy were rated differently by the 3 stages of HFpEF. Patients with more advanced stages of HFpEF experienced more challenges to be physically active.
AimsA key treatment for patients with varying stages of heart failure with preserved ejection fraction (HFpEF) is exercise. Yet, despite a Class 1A recommendation, only one-third of patients exercise sufficiently. A huge treatment gap exists between guidelines and clinical practice. PRIORITY aims to establish the feasibility, clinical effectiveness and cost-effectiveness of a hybrid centre and home-based personalized exercise and physical activity intervention for patients along the HFpEF continuum.MethodsAn assessor-blinded, multicenter randomized controlled trial will be conducted among 312 patients along the HFpEF continuum. Participants will be randomized (1:1) to the PRIORITY intervention or a comparator group receiving only a written exercise prescription. Participants in the PRIORITY group will receive 18 supervised centre-based exercise sessions during one year, supplemented with a remotely guided home-based physical activity program. Outcomes will be assessed at baseline, 4 months, one and two years. The primary outcome is the peak oxygen uptake (pVO2) at 1-year. Secondary outcomes include physical activity, other physical fitness parameters, cardiovascular health, echocardiographic parameters, health-related quality of life and costs at 1-year FU. Machine learning algorithms will analyse big data on physical activity collected during the 1-year intervention to develop models that can predict physical activity uptake and adherence as well as changes in fitness and health. A cost-utility analysis will be performed to evaluate the cost-effectiveness of the PRIORITY intervention compared to the control condition.DiscussionWe anticipate that participants in the supervised home-based exercise intervention group will have a greater increase in pVO2 compared to those receiving a written exercise prescription.Trial registration numberThis trial is registered at ClinicalTrials.gov (NCT04745013) and is currently in the recruitment stage.
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