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

Official title

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

Overview

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.

Interventions

• 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, stretch

Primary outcome measures

• Differences between groups in scores of global cognition [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in scores of sustained attention [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in verbal memory [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in scores of auditory attention [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in scores of working memory [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in scores of processing speed [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in scores of sustained attention and impulsivity [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in scores of visuospatial memory [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in scores of logical memory [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in scores of visual scanning and processing speed [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]

Secondary outcome measures (12)

• Differences between groups in Body Weight [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in waist circumference [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up]
• Differences between groups in blood pressure [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in fasting glucose [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in lipid profile [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in fasting insulin [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in scores of functionality [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in scores of quality of life [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in cognitive reserve [Time frame: Baseline only.]
• Expectation for treatment at baseline [Time frame: Baseline only.]
• Differences between groups in subjective cognitive complaints [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]
• Differences between groups in general health status [Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Consorci Sanitari de Terrassa — Terrassa

Identifiers

NCT: NCT07040748 · 202316-10Fundació la MaratóTV3

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗