RISE trial: A novel virtually delivered supervised exercise intervention targeting cognitive impairment and gut microbiome in adolescent and young adult (AYA) brain tumor survivors.

Abstract

TPS12167 Background: Up to 45% of AYA brain tumor survivors experience cancer-related cognitive impairment (CRCI) affecting processing speed, attention, working memory, and executive function—domains critically impacting quality of life (QOL). Moderate-intensity exercise can improve cognitive function by enhancing gut microbiome composition and function. However, only 50% of AYA cancer survivors receive any exercise information from medical providers, with 42% actually meeting physical activity recommendations. Considering developmental milestones and the unique needs of AYA brain tumor survivors, tailoring virtually delivered exercise interventions paired with behavioral coaching and supportive care navigation to promote the adoption of a physically active lifestyle may be a promising approach to reducing CRCI through modulation of gut microbiome health. Few randomized controlled trials (RCTs) have examined this type of exercise intervention for AYA brain tumor survivors. Additionally, the influence of the gut microbiome on the relationship between exercise and cognitive function in AYA brain tumor survivors has not yet been studied. To address these gaps, we developed the Remote Implementation of Supervised Exercise (RISE) intervention, a 12-week personalized aerobic and strength training exercise intervention with behavior coaching and supportive care navigation. The RISE trial aims to evaluate feasibility (primary), cognitive and physical activity (secondary), and gut microbial composition changes (exploratory). Methods: RISE is a two-arm 1:1 pilot RCT (NCT06799481) of 40 AYA brain tumor survivors (aged 18-39) with CRCI enrolled at Emory University and MD Anderson Cancer Center. Controls receive an activity tracker and 18 wellness calls from a trainer inquiring about adverse events and survivorship topics. Intervention participants participate in 18 virtual exercise sessions with an exercise coach, consisting of progressive aerobic and strength training exercises with active lifestyle behavior coaching. Intervention participants also receive an activity tracker and participate in self-led exercise sessions via the Physitrack telehealth app for 12 weeks. Assessments at baseline, 6, 12, and 18 weeks measure cognitive function, physical activity levels, gut microbiome, physical function, diet, and QOL. Descriptive analysis will be used to assess feasibility, defined as enrollment of 50% eligible AYAs, 75% adherence to intervention, and 80% retention at the end of the 12-week intervention. As of January 2026, 17 of 40 patients have been enrolled, and accrual is expected to be complete within 1 year. Clinical trial information: NCT06799481 .