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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-70
SponsorConsorci Sanitari de Terrassa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immersive VR-Based Multimodal Intervention (Virtual-METS)

    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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Experimental: Immersive VR-Based Multimodal Intervention (Virtual-METS)Experimental treatment 1 intervention
Group B: No Intervention: Treatment as Usual (Control Group)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Differences between groups in scores of global cognition

Global cognition is assessed with the Montreal Cognitive Assessment (MoCA) a screening tool designed to identify mild cognitive impairment (MCI) and other cognitive deficits. The MoCA takes around 10-15 minutes to complete and consists of 30 items (range=0-30). Higher scores mean a better outcome.

Time frame
Baseline, post-intervention (12 weeks), and 6-month follow-up.
2

Differences between groups in scores of sustained attention

Sustained attention is measured with the Test of Word Accentuation. Scores range from 0-30, higher scores mean a better performance.

Time frame
Baseline, post-intervention (12 weeks), and 6-month follow-up.
3

Differences between groups in verbal memory

Verbal memory is measured with the Auditory Verbal Learning Test (AVLT). It is a word-learning test where five presentations of a 15-word list are given, each followed by an attempted recall. This is followed by a second 15-word interference list (list B), followed by recall of list A. Delayed recall and recognition are also tested. For each trial, the score ranges from 0 to 15, with higher scores indicating better memory performance. The total learning score (sum of the five List A trials) ranges from 0 to 75. Delayed recall and recognition scores also range from 0 to 15. Higher scores indicate better verbal memory performance.

Time frame
Baseline, post-intervention (12 weeks), and 6-month follow-up.
4

Differences between groups in scores of auditory attention

Auditory attention is measured with Digit Span Forward (WAIS-IV). Participants are asked to repeat numbers in the same order as read aloud by the examiner. Scores range from 2 to 8, with higher scores indicating better attention span.

Time frame
Baseline, post-intervention (12 weeks), and 6-month follow-up.

Secondary outcomes

1

Differences between groups in Body Weight

Body weight measured in kilograms, used as an indicator of metabolic status.

Time frame
Baseline, post-intervention (12 weeks), and 6-month follow-up.
2

Differences between groups in waist circumference

Waist circumference measured in centimeters at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest. Indicator of abdominal fat.

Time frame
Baseline, post-intervention (12 weeks), and 6-month follow-up
3

Differences between groups in blood pressure

Systolic and diastolic blood pressure measured in mmHg using an automated sphygmomanometer after 5 minutes of rest.

Time frame
Baseline, post-intervention (12 weeks), and 6-month follow-up.
4

Differences between groups in fasting glucose

Fasting glucose levels obtained from a venous blood sample after 8-12 hours of fasting. Indicator of glycemic control.

Time frame
Baseline, post-intervention (12 weeks), and 6-month follow-up.

Other outcomes

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