Prospective randomized clinical trial on comprehensive cardiac rehabilitation combined with individualized cognitive training in older adults with heart failure and mild cognitive impairment.

Background: Older adults with heart failure (HF) are vulnerable to physical and cognitive decline due to disease exacerbations and hospitalization. Although comprehensive cardiac rehabilitation (CCR) is currently a core component of HF care, randomized controlled trials involving hospitalized patients with acute HF remain limited, and cognitive assessment has not been the primary focus of previous trials. We designed a randomized controlled trial examining whether a multifactorial intervention integrating CCR with individualized cognitive training can prevent in-hospital cognitive decline in older adults with HF and mild cognitive impairment (MCI). Methods: This is a single center, prospective, open-label, controlled superiority trial. Patients aged ≥65 yr who are hospitalized for HF, undergo CCR, and meet the criteria for MCI, defined by a Japanese version of the Montreal Cognitive Assessment (MoCA-J) score of 17-22, will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either the intervention group receiving CCR plus individualized cognitive training using BrainHQ or the control group receiving CCR alone. Cognitive training will be conducted for 20 min/day, 5 days/week, for at least 2 weeks. The primary endpoint is the change in MoCA-J score from baseline to discharge. Secondary endpoints include changes in self-care, anxiety/depression, and physical function, as well as unplanned readmissions and major cardiovascular events within 12 months after discharge. Conclusions: This trial will evaluate whether adding individualized cognitive training to CCR can prevent cognitive decline during hospitalization in patients with HF and MCI, providing evidence regarding the feasibility and potential value of this intervention.