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

NCT ID: NCT07040748

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-04-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Immersive VR-Based Multimodal Intervention (Virtual-METS)

Participants in this arm will receive a multimodal group-based intervention using immersive virtual reality (IVR) without headsets. The intervention includes mindfulness (10 minutes), cognitive training (30 minutes), and physical exercises (20 minutes) delivered through MK360 immersive technology. Sessions are conducted in groups of 5 participants, twice per week for 12 weeks (24 sessions in total), led by a neuropsychologist.

Group Type: EXPERIMENTAL

Immersive VR-Based Multimodal Intervention (Virtual-METS)

Intervention Type: BEHAVIORAL

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.

No Intervention: Treatment as Usual (Control Group)

Participants in this arm will continue with their usual care, including routine medical visits and remotely administered psychoeducational guidelines to support diet, physical activity, and adherence to pharmacological treatment. They will not receive any specific intervention during the study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Demonstrated criteria for the MetS: central obesity (waist circumference ≥ 94 cm for men or ≥ 80 cm for women) and at least 2 of the criteria described as follow: Triglycerides ≥ 150 mg/dl or specific treatment of this lipid disorder; HDL-C < 40 mg/dl (men) or < 50 mg/dl (women) or specific treatment of this lipid disorder; Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg or previously diagnosed hypertension treatment; Basal glycemia ≥ 100 mg/dl or type 2 diabetes previously diagnosed).
• Age: between 45 and 70 years old.
• Subjective cognitive complaints: Subjective Cognitive Decline Questionnaire (≥ 7).
• Ability to fully understand and speak Spanish or Catalan.

Exclusion Criteria

• Confirmed or suspicion of dementia (MMSE<24).
• Diagnosis of severe psychiatric, neurological, developmental disorders, systemic pathologies, hematological, hormonal, nutritional pathology, and/or neoplasm that are known to cause cognitive deficits.
• Other severe comorbidities considered a probable bias for the study: a cardiac history of unstable angina, recent myocardial infarction within the last 3 months, congestive heart failure, significant heart valve dysfunction, or unstable hypertension; taking medications that could negatively affect cognitive function.
• Physical, motor, or sensory alterations that impede the neuropsychological examination or the rehabilitation program.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorci Sanitari de Terrassa

OTHER

Sponsor Role: lead

Responsible Party

Maite Garolera

Principal Investigator of the Brain, Cognition, and Behavior Research Group (C3-CST).

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Consorci Sanitari de Terrassa

Terrassa, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Maite Garolera

Role: CONTACT

mgarolera@cst.cat

+34937310007

Facility Contacts

Maite Garolera

Role: primary

mgarolera@cst.cat

+34937310007

Other Identifiers

202316-10Fundació la MaratóTV3

Identifier Type: -

Identifier Source: org_study_id