Clinical trial NCT05682469: Effects and Mechanism of the Fully Immersive Virtual Reality Cognitive Training Based on Leisure Activities
Official title: Effects and Mechanism of the Fully Immersive Virtual Reality Cognitive Training Based on Leisure Activities: Cognitive, Daily Function, Quality of Life, Metabolic Biomarkers, and Electroencephalography
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: MCI
SCD
Keywords: Mild cognitive impairment
Subjective cognitive decline
Combination therapy
Virtual reality
Cognitive training
Leisure activities
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 275
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to identify the effects of the immersive leisure-based VR cognitive training, and compare the intervention effects for elderly with MCI and SCD. The investigators anticipate the VR training can facilitate cognitive function, daily function, quality of life. The investigators anticipated the metabolic biomarkers, mechanism, and brain activities will be found. The significance of this study is identifying the effect of immersive leisure-based VR cognitive training, and confirming the metabolic biomarkers and brain activities. It could improve the accuracy of identification, prevent the progression to dementia, and lead the field of technological assistance to new opportunities for training.


Eligibility criteria: Inclusion Criteria:

-

MCI Inclusion Criteria:

age\>=60 able to follow instruction MoCA\<26 Scores on cognitive tests for individuals with MCI are 1 to 1.5 standard deviations below the mean for their age and education matched peers on culturally

SCD Inclusion Criteria:

age\>=60 ECog-12 score \>1 MoCA\>=26; does not conform the standards of MCI and dementia

Exclusion Criteria:

- dizziness or epilepsy history; neurological or other orthopedic diseases with neurological or other orthopedic diseases unstable physical condition of VR cognitive training Recent psychiatric diagnosis, such as depression

Primary outcomes:
measure: Change scores of the Montreal Cognitive Assessment (MoCA).
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Wechsler Memory Scale (WMS)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Stroop test
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Color trials test
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Wechsler Adult Intelligence Scale; WAIS
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of the short (12-item) form of the Everyday Cognition Scale (ECog-12)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Amsterdam Instrumental Activity of Daily Living,A-IADL
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Taiwan Performance-based IADL; TPIADL
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of the World Health Organization Quality of Life-Old(WHOQOL-OLD) Taiwan Version
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of WHOQOL-bref Taiwan Version
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Geriatric Depression Scale,GDS
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of The Chinese Aging Well Profile (CAWP)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: