An open-source system for efficient clinical trial support: The COMET study experience.

Exercise clinical trials are complex, logistically burdensome, and require a well-coordinated multi-disciplinary approach. Challenges include managing, curating, and reporting on many disparate information sources, while remaining responsive to a variety of stakeholders. The Combined Exercise Trial (COMET, NCT04848038) is a one-year comparison of three exercise modalities delivered in the community. Target enrollment is 280 individuals over 4 years. To support rigorous execution of COMET, the study team has developed a suite of scripts and dashboards to assist study stakeholders in each of their various functions. The result is a highly automated study system that preserves rigor, increases communication, and reduces staff burden. This manuscript describes system considerations and the COMET approach to data management and use, with a goal of encouraging further development and adaptation by other study teams in various fields.

Promoting Alzheimer's Risk-Reduction through Community-Based Lifestyle Education and Exercise in Rural America: A Pilot Intervention.

INTRODUCTION: Rural Americans (RA) have poorer vascular health and physical activity levels than their urban counterparts; all are dementia risk factors. Dementia risk reduction among rural individuals requires a tailored approach. The purpose of this project was to examine preliminary efficacy of a community-based physical exercise and/or dementia risk factor-reduction curriculum among rural adults 50 and older. METHODS: Seventy-five rural dwelling adults 50 and older were randomized to one of three groups: 1) 10 weeks of Alzheimer's disease risk-reduction education (ED), 2) risk-reduction education and supervised exercise (EDEX) or 3) control group (CON). Outcomes included baseline to 10-week follow-up difference in dementia knowledge (primary outcome) and physical activity, muscular endurance, healthy lifestyle engagement, and anthropometrics (secondary outcomes). RESULTS: Sixty-nine adults successfully completed the 10-week study. Dementia knowledge increased in a Treatment Arm-dependent manner (χ2 = 6.95 (2), p = 0.03), being ED and EDEX superior to CON. Engagement in healthy lifestyle behaviors did not change statistically. However, participation specifically in physical activity increased over time (χ2 = 11.47 (2), p = 0.003) with EDEX reporting the greatest increases. No significant change in average daily steps was observed for any group. CONCLUSION: The results suggested dementia risk-reduction education, both with and without structured exercise, leads to improvements in dementia knowledge. When coupled with regular, supervised exercise, this education intervention also helped participants increase engagement in physical activity over 10 weeks. Tailored interventions that combine Alzheimer's disease education and regular, supervised exercise may help reduce dementia risk in rural communities.