Effect of a Multicomponent Exercise Program with Virtual Reality (MEP-VR) versus standard approaches on functional and cognitive domains in hospitalised geriatric patients: Study protocol for a randomized controlled trial

Background: Conventional care models for older adults often disregard negative effects of hospitalization and neglect potential benefits of technology. This trial aims to investigate effects of Multicomponent Exercise Program with Virtual Reality (MEP-VR) on functional and cognitive outcomes in hospitalized older adults, compared to MEP-only or usual care approaches. Methods: This three-arm, parallel-group, randomized controlled trial will include 255 participants aged 75 or older, with a Barthel Index score of at least 60, able to walk and cooperate, have an estimated hospital stay of at least four days, and provide informed consent. Patients with severe dementia, terminal illness, or clinical instability will be excluded. Participants will be randomly assigned to a control group or one of two intervention groups. The intervention groups will receive either MEP-VR or MEP-only program, consisting of supervised aerobic exercise, resistance training, and balance training, with or without a virtual reality component. The intervention will occur over four consecutive days, each session lasting 30-40min. The primary outcome measure will be functional changes at discharge. Cognition, mood, quality of life, and immersive virtual reality (IVR) usability will also be assessed. Discussion: Technological advances are rapidly increasing with population aging, creating potential benefits for integrating technology into older adult care. This study will evaluate the implementation of IVR combined with MEP. If our hypothesis proves accurate, it will pave the way for modifying the hospitalization system, helping to reduce the critical healthcare burden resulting from hospital-acquired disability in the older population. Trial registration: This study was approved by the Navarra Clinical Research Ethics Committee on June 14th, 2021 (PI_2021_90). The trial was retrospectively registered at ClinicalTrials.gov, registration number NCT06469554.