ABSTRACT
Aims: A 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. Methods: An 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. Discussion: We 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 number: This trial is registered at ClinicalTrials.gov (NCT04745013) and is currently in the recruitment stage.
ABSTRACT
Intermittent claudication (IC) is characterized by decreased blood flow and oxygen delivery to the lower-limb muscles, resulting in pain and impaired functional capacity. This study evaluated the effects of a 12-week hybrid walking intervention on muscle oxygenation and functional capacity in 38 patients with IC (Rutherford I-III). Functional capacity was evaluated by means of two different treadmill test protocols and a six-minute walk test (6MWT). Muscle oxygenation was assessed during the treadmill tests using near-infrared spectroscopy. After the intervention, maximal walking distance was significantly increased (p < 0.001) during the progressive maximal treadmill test (mean (SD): +155 (SD 177) metres) and 6MWT (+18 (SD 29) metres) metres, with concomitant improvements in muscle oxygenation measures. Deoxygenation was slower during the progressive maximal test (p < 0.001) and reoxygenation was faster during recovery (p = 0.045). During the more submaximal test, oxygenated haemoglobin was better preserved (p = 0.040). Slower deoxygenation was more pronounced in the high responders of the progressive maximal treadmill test (p = 0.002). The findings suggest that preserved oxygen availability and slower deoxygenation during exercise could partly explain the improvements in functional capacity.
