Beyond the HULK study: rationale of the PIpELINe randomized clinical trial
death, HULK
ADVERSE EVENTS, MYOCARDIAL INFARCTION
The HULK study demonstrated that an early, tailored, and low-cost exercise intervention is safe and feasible in older patients hospitalized for ACS and effectively improves physical performance as assessed by SPPB score. However, the HULK trial has two major limitations. First, it mainly focused on exercise training, and it should not be considered a multi-domain intervention that may be further beneficial in the context of older MI patients. Second, it was underpowered for hard clinical endpoints. Although many previous studies have associated SPPB value with mortality and we found a reduction of adverse events at one-year follow-up, the HULK population was powered to appreciate significant changes in SPPB value, but findings regarding the outcome should be considered with caution. This is the starting point of the “Physical Activity Intervention in Elderly after Myocardial Infarction (PIpELINe)” randomized clinical trial. The aim of the PIpELINe trial is to investigate if an early, tailored and low-cost multi-domain lifestyle intervention combining exercise training, dietary counselling, and aggressive control of risk factors reduces CV death or rehospitalization for CV causes in older MI patients as compared to standard of care.