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

NCT07040748 | Recruiting

• 1 other identifier: 202316-10Fundació la MaratóTV3
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Metabolic syndrome; Cognitive impairment; Virtual Reality; Cognitive Training

Outcome Measures

Primary Outcomes (15)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• Differences between groups in scores of working memory

  Working memory is assessed using Digit Span Backward (WAIS-IV), where participants repeat number sequences in reverse order. Scores range from 2 to 8, with higher scores indicating better working memory.

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

• Differences between groups in scores of processing speed

  Processing speed is measured with the Digit Symbol Coding subtest from the WAIS-III. It consists of replacing symbols that lack verbal meaning with numbers based on a key. Scores range from 0 to 133, with higher scores indicating better processing speed.

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

• Differences between groups in scores of sustained attention and impulsivity

  Conners Continuous Performance Test - 3rd Edition (CPT-3) is task-oriented computerised assessment of attention-related problems. Participants are presented with a repetitive array of visual stimuli on a computer screen for 14 min. Participants are instructed to press the space bar every time a letter other than "X" appears and to not press the space bar when "X" appears. The rate of stimulus presentation varies according to 1, 2, and 4 s intervals throughout the task. Measures: Correct Detection (Higher rates indicate better outcome), Reaction times (Lower scores indicate better outcome), Omission errors (Lower rates indicate better outcome), and Commission errors (Lower rates indicate better outcome).

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

• Differences between groups in scores of visuospatial memory

  Visuospatial memory is assessed with the Brief Visuospatial Memory Test - Revised (BVMT-R). Immediate memory is evaluated through the total score of three learning trials, with scores ranging from 0 to 36. Delayed memory is assessed through free recall (score range: 0 to 12) and recognition (number of correctly identified figures, corrected for false positives). Higher scores indicate better visuospatial memory performance.

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

• Differences between groups in scores of logical memory

  Verbal episodic memory is assessed with Logical Memory I and II (WMS-IV), evaluating immediate and delayed recall of short stories. Scores range from 0 to 25 for each story, with a maximum total score of 50 when two stories are administered. In addition, a recognition phase is included, with scores ranging from 0 to 30. Higher scores across all components indicate better verbal episodic memory.

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

• Differences between groups in scores of visual scanning and processing speed

  Visual scanning and processing speed are measured with the Trail-Making Test-A version. Participants are asked to connect a series of numbered circles on a page in numerical order. Completion time is recorded in seconds, with lower scores indicating better performance.

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

• Differences between groups in scores of executive function and cognitive flexibility

  Executive functioning and cognitive flexibility are measured with the Trail-Making Test-B version. Participants are asked to connect a series of circles that contain both numbers and letters in alternating numerical and alphabetical order. Completion time is recorded in seconds, with lower scores indicating better performance.

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

• Differences between groups in scores of executive functioning

  Executive functioning is assessed with the Modified Wisconsin Card Sorting Test (M-WCST), which evaluates abstract reasoning, cognitive flexibility, and the ability to shift problem-solving strategies. Performance is scored based on the number of categories completed, total errors, and perseverative errors. Higher scores in perseverative errors (range: 0 to \>23) and total errors (range: 0 to \>31) indicate worse performance, while more categories completed reflect better executive functioning (range: 0 to 8).

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

• Differences between groups in scores of selective attention, inhibition, and processing speed

  Selective attention, inhibition, and processing speed are measured with the Stroop Color and Word Test. Participants are asked to name the color of a series of color patches (Stroop Color Naming), read a series of color words (Stroop Word Reading), and name the color of a series of color words where the word and color do not match (e.g., the word "red" written in blue ink), Stroop Color-Word Interference. Higher scores mean a better outcome.

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

• Differences between groups in scores of phonetic fluency

  Phonemic verbal fluency is assessed using the PMR test, in which participants are asked to produce as many words as possible beginning with the letters P, M, and R, one minute per letter. The total score is the sum of all correct, non-repeated words across the three trials. Higher scores indicate better phonemic fluency and executive function.

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

• Differences between groups in scores of semantic verbal fluency

  Semantic verbal fluency is assessed with a category fluency task in which participants are asked to name as many words as possible belonging to a specific semantic category (e.g., animals, fruits) within one minute. The total score is the number of correct, non-repeated words produced. Higher scores indicate better semantic fluency and lexical access.

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

Secondary Outcomes (43)

• Differences between groups in Body Weight

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

• Differences between groups in waist circumference

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

• Differences between groups in blood pressure

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

• Differences between groups in fasting glucose

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

• Differences between groups in lipid profile

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

Study Arms (2)

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

EXPERIMENTAL

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.

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

No Intervention: Treatment as Usual (Control Group)

NO INTERVENTION

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.

Interventions

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.

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

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, 08227, Spain

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Maite Garolera

CONTACT

+34937310007; mgarolera@cst.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of the Brain, Cognition, and Behavior Research Group (C3-CST).

Model Details: Randomized controlled trial with two parallel groups: one receiving a multimodal group-based intervention using immersive virtual reality (Virtual-METS), and a control group receiving treatment as usual. The intervention consists of 24 sessions over 12 weeks.

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 27, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)