Abstract
The outbreak of severe acute respiratory syndrome coronavirus 2, also known as Coronavirus Disease 2019 (COVID-19) sparked a global public health pandemic that has impacted every aspect of daily life. Medical research was affected, and many clinical trials were halted to minimize COVID-19 transmission risk and spread while the world navigated this novel virus. Here we describe the relaunch of our virtual reality (VR) pilot clinical trial that uses an in-lab brain and body training program to promote brain health in mid-to-late life older adults, in the era of COVID-19. This case series includes five healthy female participants between 51 and 76 years of age, a subset of a larger VR pilot clinical trial that started pre-pandemic. We developed a revised study protocol based on the Center for Disease Control and World Health Organization guidelines to help manage the spread of COVID-19. Since the limited resumption of clinical trials at our institution in August 2020, we successfully completed over 200 in-lab virtual reality training sessions using our revised protocol. During this time, none of the five participants or three study staff reported any COVID-19 symptoms or reported a positive COVID-19 test. More than 40 voluntary COVID-19 tests were completed by our study staff over the last 6 months. All participants rated our safety protocol as very satisfied or extremely satisfied and that they would be very likely or extremely likely to participate in a VR clinical trial during the pandemic. Based on these findings, we suggest that continued VR clinical trial research during the COVID-19 pandemic is achievable and can be safely resumed if specific safety protocols are in place to mitigate the risk of exposure and spread of COVID-19.
Highlights
Severe acute respiratory syndrome coronavirus 2, known as Coronavirus Disease 2019 (COVID-19), is an infectious respiratory illness believed to spread primarily by person-to-person contact (Chu et al, 2020)
We describe the safety protocol and outcomes from our virtual reality (VR) pilot clinical trial that uses an inlab brain and body training program to promote brain health in mid-to-late life older adults
Studies have shown that it is safe and feasible for healthy subjects to participate in moderate-strenuous aerobic physical activity with a face mask on (Epstein et al, 2020), there is no information about the feasibility of wearing a face mask in the presence of an eye mask for VR
Summary
Severe acute respiratory syndrome coronavirus 2, known as Coronavirus Disease 2019 (COVID-19), is an infectious respiratory illness believed to spread primarily by person-to-person contact (Chu et al, 2020). Inhaling aerosols or respiratory droplets from an infected individual who coughs, sneezes, or speaks contributes to disease spread (Kutter et al, 2018). Aerosols are smaller than 5 μm and have a low settling velocity which causes. VR in the COVID-19 Era them to remain in the air for longer periods of time (Ge et al, 2020). This low settling velocity allows the disease to become airborne and increases the risk of transmission. Older adults (55+) are at an increased risk of becoming critically ill or dying from contracting this virus, because viral infections progress more rapidly in weaker immune systems (Rothan and Byrareddy, 2020). Minorities and other marginalized groups have been disproportionately affected by this virus (Laurencin and McClinton, 2020)
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