Abstract
BackgroundReduced physical performance and impaired mobility are common in elderly patients after acute coronary syndrome (ACS) and they represent independent risk factors for disability, morbidity, hospital readmission and mortality. Regular physical exercise represents a means for improving functional capacity. Nevertheless, its clinical benefit has been less investigated in elderly patients in the early phase after ACS. The HULK trial aims to investigate the clinical benefit of an early, tailored low-cost physical activity intervention in comparison to standard of care in elderly ACS patients with reduced physical performance.DesignHULK is an investigator-initiated, prospective multicenter randomized controlled trial (NCT03021044). After successful management of the ACS acute phase and uneventful first 1 month, elderly (≥70 years) patients showing reduced physical performance are randomized (1:1 ratio) to either standard of care or physical activity intervention. Reduced physical performance is defined as a short physical performance battery (SPPB) score of 4–9. The early, tailored, low-cost physical intervention includes 4 sessions of physical activity with a supervisor and an home-based program of physical exercise. The chosen primary endpoint is the 6-month SPPB value. Secondary endpoints briefly include quality of life, on-treatment platelet reactivity, some laboratory data and clinical adverse events. To demonstrate an increase of at least one SPPB point in the experimental arm, a sample size of 226 patients is needed.ConclusionsThe HULK study will test the hypothesis that an early, tailored low-cost physical activity intervention improves physical performance, quality of life, frailty status and outcome in elderly ACS patients with reduced physical performance.Trial registrationClinicaltrials.gov, identifier NCT03021044, first posted January, 13th 2017.
Highlights
Reduced physical performance and impaired mobility are common in elderly patients after acute coronary syndrome (ACS) and they represent independent risk factors for disability, morbidity, hospital readmission and mortality
Preserving functional capacity and physical performance in elderly people admitted to the hospital for acute coronary syndrome (ACS) has become more important given the aging of population
Study population HULK is a prospective, multicenter, interventional, randomized study enrolling patients from three Italian Cardiology units (Azienda Ospedaliera Universitaria di Ferrara, Ferrara; Ospedale Santa Maria delle Croci, Ravenna, Ospedale San Giovanni da Saliceto, Piacenza) and from three outpatient services dedicated to physical activity intervention (Center of Biomedical Studies Applied to Sport, Ferrara; Sport Medicine Center, Ravenna; Sports Medicine Service, Azienda Unità Sanitaria Locale, Piacenza)
Summary
Reduced physical performance and impaired mobility are common in elderly patients after acute coronary syndrome (ACS) and they represent independent risk factors for disability, morbidity, hospital readmission and mortality. It is known that the incidence of cardiovascular diseases is age-related and that reduced physical performance and impaired mobility are significantly more frequent in elderly subjects [4] In these subjects, functional status represents a primary indicator of health status and provides useful prognostic information. As a matter of fact, some studies have demonstrated that those who benefit most from physical activity interventions are the elderly, but only few previous studies have enrolled patients aged ≥65 years [6, 7] This is mainly due to difficulties related to compliance, associated logistic problems and lack of encouragement from physicians [8]. The mean age of ACS patients has increased progressively in recent years and, current interventional and medical treatment have significantly improved prognosis, the disability and morbidity burden is still huge
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