ABSTRACT
Background EXERT, a multisite 18-month RCT, is testing the effects of aerobic exercise vs. stretching on cognition and AD biomarkers in sedentary adults with MCI. In the first 12 months, participant exercise 2x/week under the supervision of YMCA trainers, and 2x/week on their own. In months 13-18, participants continue to exercise 4x/week but without supervision. Here we describe the impact of the COVID-19 pandemic on delivery of this support-intensive intervention that involved many challenges but also opportunities for innovation. Method In February 2020, EXERT met the recruitment goal with 296 enrolled. In March 2020 when COVID-19 incidence rates began to climb in the US, study assessments and per-protocol intervention delivery were paused. During the pause, all YMCAs were closed, and the majority of study-certified YMCA trainers were furloughed. Result At the time of the pause (March 23), 153 participants were in the supervised phase of the study, and 65 participants were in the unsupervised phase. To keep participants engaged and encourage adherence to the intervention, sites initiated weekly calls with active participants to provide support, address barriers to exercise and collect self-report adherence data. By September, 7 of 14 sites resumed study activities. Weekly call completion rates during the pause exceeded 85%, and participants reported completing a mean of 3.3 40-minute exercise sessions per week. On these calls, participants frequently expressed gratitude for the regular contact. By February 2021, all sites resumed activities despite COVID infection rates that have continued to climb across the US. In response, supervised exercise for the majority of participants was transitioned from in-person to web-conferencing. Even with this change that can be challenging for MCI, supervised session adherence rates are 72% for the aerobic group and 79% for the stretching group. Retention has remained high at 87%. Conclusion The COVID-19 pandemic presented unprecedented challenges, but it also provided unique opportunities to adapt intervention delivery so that a community-based exercise trial could continue ? even during a debilitating global health crisis. EXERT?s adaptations may ultimately impact resilience of the intervention to even the most challenging of circumstances that older adults with MCI will face now and in the future.
ABSTRACT
With improved healthcare, the Down syndrome (DS) population is both growing and aging rapidly. However, with longevity comes a very high risk of Alzheimer's disease (AD). The LIFE-DSR study (NCT04149197) is a longitudinal natural history study recruiting 270 adults with DS over the age of 25. The study is designed to characterize trajectories of change in DS-associated AD (DS-AD). The current study reports its cross-sectional analysis of the first 90 subjects enrolled. Plasma biomarkers phosphorylated tau protein (p-tau), neurofilament light chain (NfL), amyloid ß peptides (Aß1-40, Aß1-42), and glial fibrillary acidic protein (GFAP) were undertaken with previously published methods. The clinical data from the baseline visit include demographics as well as the cognitive measures under the Severe Impairment Battery (SIB) and Down Syndrome Mental Status Examination (DS-MSE). Biomarker distributions are described with strong statistical associations observed with participant age. The biomarker data contributes to understanding DS-AD across the spectrum of disease. Collectively, the biomarker data show evidence of DS-AD progression beginning at approximately 40 years of age. Exploring these data across the full LIFE-DSR longitudinal study population will be an important resource in understanding the onset, progression, and clinical profiles of DS-AD pathophysiology.