Enhancing Cognitive Functions in Older Adults With Mild Cognitive Impairment via Virtual Sail 3D: Protocol for a Feasibility Randomized Controlled Trial

BACKGROUND: Innovative approaches, such as virtual reality (VR)-based cognitive rehabilitation, are becoming essential to healthy aging. OBJECTIVE: This study aims to evaluate the feasibility and generate preliminary evidence regarding the effectiveness of an immersive VR-based cognitive remediation intervention for older individuals with mild cognitive impairment (MCI). METHODS: A total of 40 individuals aged 65 years and older, of both genders with MCI, will be recruited and randomly assigned to the experimental or control group. The experimental group will participate in a 6-week VR-based cognitive remediation program, while the control group will receive healthy lifestyle education. Feasibility will be assessed through measures, including dropout rates, side effects, and satisfaction with the program. Preliminary effectiveness will be evaluated using assessments of cognitive functions, quality of life, functional mobility, depression and anxiety symptoms, regulation of social and biological rhythms, body awareness, and physical activity levels. RESULTS: Recruitment began in May 2024 and is expected to conclude by November 2025; to date, 153 participants have been recruited and screened, with 39 enrolled. Preliminary analyses are planned for January 2026 and follow-up analyses for January 2027. CONCLUSIONS: This trial will provide insights into the feasibility and preliminary effectiveness of a VR-based intervention for older adults with MCI, with implications for its integration into preventive and rehabilitative care. TRIAL REGISTRATION: ClinicalTrial.gov NCT06579378; https://clinicaltrials.gov/search?term=NCT06579378. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/85089.