Physical activity intervention for elderly patients with reduced physical performance after acute coronary syndrome (HULK study): rationale and design of a randomized clinical trial.

BACKGROUND: 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. 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. DESIGN: HULK 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. CONCLUSIONS: The 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 REGISTRATION: Clinicaltrials.gov, identifier NCT03021044 , first posted January, 13th 2017.

[Preventive cardiology: comparisons of European and Italian projects with the Cardiac Units from Emilia Romagna region. A workshop of IACPR/GICR - Emilia Romagna]. / La Cardiologia Preventiva: prospettive nazionali ed europee a confronto con le Cardiologie dell'Emilia Romagna. Workshop IACPR/GICR - Emilia Romagna.

A workshop endorsed by the Italian Association of Cardiovascular Prevention and Rehabilitation--Emilia Romagna Section--held in Piacenza in May 2011, gave the opportunity to discuss the emerging role of Preventive Cardiology in the modern era. From the new documents recently published by the European and Italian Scientific Associations, the barriers in their implementation, and the contribution of the health care providers, physicians, nurses, both in primary and secondary prevention were discussed. The local initiatives of cardiac prevention in different areas were presented and compared. A new project of secondary prevention in the follow-up and management of patients with dilated cardiomyopathy and heart failure promoted by the Emilia Romagna Region Health Authority was presented.