ABSTRACT
Background U.S. POINTER is testing whether multidomain lifestyle interventions focused on physical exercise, nutrition, cognitive challenge, and risk factor management reduces risk of cognitive decline in a heterogeneous population of at-risk older adults in America. The study adapts the FINGER (Finnish Intervention Geriatric Study to Prevent Cognitive Impairment and Disability) interventions to fit the United States culture and delivers the intervention within the community at 5 sites across the country. Method U.S. POINTER is a 2-year RCT that will enroll 2000 cognitively unimpaired older adults who are at risk for cognitive decline due sedentary lifestyle, poor diet and other factors. Participants are randomized to one of two lifestyle intervention groups that differ in format and intensity. In 2020, the COVID-19 pandemic presented a number of challenges for the study that affected recruitment, assessment schedules, and intervention delivery. Result As of March 2020, when COVID-19 incidence was on an exponential rise in the US, 240 participants had been enrolled in U.S. POINTER. In response to local and national safety mandates, study activities were paused from March 23rd to July 13th. During the pause, sites remained in contact with study candidates and enrolled participants to provide ongoing support to keep them engaged in the trial. Enrollees also received regular telephone calls to encourage continued adherence to their assigned lifestyle intervention. In response to the multiple pandemic-related challenges, study protocols and procedures were adapted to facilitate and encourage participant adherence to intervention activities. At study re-start, retention was 98%. Despite climbing COVID-19 infection rates nationwide, enrollment at all 5 sites has continued at a steady rate (N=540 as of Jan2021), virtual Team Meeting attendance for both lifestyle groups exceeds 80%, and participants continue to successfully work toward their intervention goals. Conclusion The COVID-19 pandemic presented unprecedented challenges, but it also provided a unique opportunity to adapt intervention delivery so that a nonpharmacological community-based trial could continue ? even during a debilitating global health crisis. U.S. POINTER?s adaptations to pandemic-related challenges may ultimately increase the resilience of its interventions to even the most challenging of circumstances that older adults will face now and in the future.
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.