IMOVE: Protocol for a randomized, controlled 2x2 factorial trial of improvisational movement and social engagement interventions in older adults with early Alzheimer's disease.

Background: In addition to cognitive impairment, people with Alzheimer's disease (PWAD) experience neuropsychiatric symptoms (e.g., apathy, depression), altered gait, and poor balance that further diminish their quality of life (QoL). Here, we describe a unique, randomized, controlled trial to test the hypothesis that both movement and social engagement aspects of a group dance intervention alter the connectivity of key brain networks involved in motor and social-emotional functioning and lead to improved QoL in PWAD. Methods: IMOVE (NCT03333837) was a single-center, randomized, controlled 2x2 factorial trial that assigned PWAD/caregiver dyads to one of 4 study conditions (Movement Group, Movement Alone, Social Group, or Usual Care control). The Movement Group participated in twice-weekly group improvisational dance (IMPROVment® Method) classes for 12 weeks. The Movement Alone intervention captured the same dance movement and auditory stimuli as the group class without social interaction, and the Social Group used improvisational party games to recapitulate the fun and playfulness of the Movement Group without the movement. The primary outcome was change in QoL among PWAD. Key secondary outcomes were functional brain network measures assessed using graph-theory analysis of resting-state functional magnetic resonance imaging scans, as well as neuropsychiatric symptoms, gait, and balance. Results: A total of 111 dyads were randomized; 89 completed the study, despite interruption and modification of the protocol due to COVID-19 restrictions (see companion paper by Fanning et al.). The data are being analyzed and will be submitted for publication in 2023.