Adverse Events in Older Adults at Risk for Dementia During Remote Physical Exercise and Cognitive Training

Background: SYNchronizing Exercises, Remedies in GaIt and Cognition @Home (SYNERGIC@Home/SYNERGIE~Chez soi) is a home-based, double-blind, randomized controlled trial. Sixty community dwelling older adults (aged 60-90 years), living in New Brunswick, Canada, who were at risk of dementia participated remotely using secure videoconferencing. Participants underwent 16 weeks (three sessions/week) of cognitive and physical interventions. This research aimed to determine the frequency, severity, and relationship of adverse events (AEs) that occurred during the physical and cognitive intervention phase of the SYNERGIC@Home study. This study addressed a critical question: Whether AEs occurring during a remote exercise and cognitive intervention for older adults at risk of dementia can be managed safely and effectively to optimize participation. Methods: All AEs were recorded, including type, severity, and their relatedness to the intervention. Intervention modifications due to AEs were also recorded. Results: Participant's mean age was 69.5 years (SD=6.47), 76.7% were female, and 58.4% were living in suburban or urban communities. A total of 88 AEs affected 42 (70.0%) participants. Most AEs (71.6%) were unrelated to the intervention, and 69.3% were classified as mild, with musculoskeletal issues being the most common AE (39.8%). One unrelated serious AE was recorded. Modifications to the physical intervention were made for 31 participants, and two discontinued due to unrelated medical issues. Conclusions: When delivered remotely, physical and cognitive interventions resulted in no serious related AEs and the few related, mostly mild AEs, were safely managed through modifications to the physical interventions.