NCT07040748

Immersive Virtual Reality Training for Improving Cognition in Adults With Metabolic Syndrome

Multimodal Immersive Virtual Reality Training for Improving Cognition in Adults With Metabolic Syndrome: A Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Consorci Sanitari de Terrassa · Academic / Other
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effectiveness of a multimodal intervention using immersive virtual reality (Virtual-METS) to improve cognitive function in middle-aged adults with metabolic syndrome and subjective cognitive complaints. The intervention combines cognitive training and physical exercise in group sessions over 12 weeks.

Detailed description

Metabolic syndrome (MetS) has been associated with an increased risk of cognitive decline and potentially Alzheimer's disease. Given the high prevalence of MetS in older adult populations, there is an urgent need for alternative, non-pharmacological solutions to improve cognitive impairment associated with MetS. Immersive Virtual Reality (IVR) technology offers a unique opportunity to improve traditional interventions and accessibility for populations with physical, cognitive, or emotional constraints. The Virtual-METS project aims to evaluate the effects of a multimodal IVR intervention that combines cognitive training and physical exercise on eighty- four adults with MetS, aged between 45 and 70 years, and with subjective cognitive complaints. Participants will be randomly assigned to either the experimental group (Virtual-METS) or the control group (treatment as usual, TAU) in a single-blind, randomized clinical trial. The Virtual-METS intervention will be delivered in a group session with 5 participants, twice per week for 12 weeks (24 sessions). Measures of cognition, assessed by a neuropsychological battery and eye-tracking tasks (primary measures), as well as treatment compliance, functionality, and quality of life (secondary measures), will be assessed at baseline, post-treatment, and after 6 months. In addition, ophthalmologic examinations, carotid Doppler ultrasound, and a panel of blood-based and gut-derived biomarkers will be collected to explore physiological mechanisms underlying cognitive and clinical changes. An economic evaluation of cost-effectiveness, treatment costs, and quality-adjusted life-years, compared to TAU, will also be conducted.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Immersive VR-Based Multimodal Intervention (Virtual-METS)	This intervention consists of a 12-week, group-based program using immersive virtual reality technology (MK360) without head-mounted displays. Each 60-minute session combines mindfulness practices adapted from the Mindfulness-Based Stress Reduction (MBSR) program, cognitive training targeting attention, processing speed, memory, and executive function through realistic virtual environments (such as parks, markets, or home interiors), and chair-based physical exercises focused on balance, stretching, and muscle strengthening. The intervention is delivered in small groups of five participants, twice per week, for a total of 24 sessions, and is led by a trained neuropsychologist.

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2025-06-27
• Last updated: 2025-06-27

Locations

1 site across 1 country: Spain