Clinical trial NCT04779671: Effects of the Fully Immersive VR Cognitive Training Based on Leisure Activities for the Elderly With MCI and SCD.
Official title: Effects of the Fully Immersive Virtual Reality Cognitive Training Based on Leisure Activities for the Elderly With Mild Cognitive Impairment and Subjective Cognitive Decline.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: MCI
SCD
Virtual Reality
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 190
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mild cognitive impairment (MCI) and subjective cognitive decline (SCD) are risk groups for dementia, and thus appropriate interventions are required. Cognitive training is a common intervention applied to the elderly with cognitive decline.

Cognitive training integrated into leisure activities can increase the training motivation of the elderly, while improving cognitive performance and daily functions. Virtual reality (VR) can simulate daily living situations, and it can be an effective intervention with cognitive training. Although a few studies have found immersive VR cognitive training can improve the cognitive function of the elderly with cognitive decline, these studies have shown inconsistent results. In addition, it is yet not clear the long-term effect of fully immersive VR cognitive training and its impact on daily function. Furthermore, for immersive VR cognitive training, there is still a lack of training programs that integrate into the context of leisure activities. This type of VR cognitive training could help the effectiveness of cognitive training to be transferred into daily functions.

Detailed description: This study aims to (1) determine the feasibility and usability of immersive leisure-based VR cognitive training; (2) identify the intervention effects of immersive leisure-based VR cognitive training on cognitive function, daily function, and quality of life for elderly with MCI and SCD; (3) compare the intervention effects between elderly with MCI and SCD on outcome measures.

The investigators will recruit 30 elderly with MCI, 30 elderly with SCD, and 15 specialists for the feasibility and usability study. They will receive one immersive leisure-based VR cognitive training for 30 minutes. VR cognitive training receives four gardening activities. The cognitive elements including attention, working memory, processing speed, and executive function incorporated training. The investigators will use the Acceptance of the Virtual Reality (VR) Experience Questionnaire and System Usability Scales. For effectiveness study, the investigators will recruit 60 elderly with MCI and 70 elderly with SCD. Participants will be randomly assigned to VR group and control group. All participants will receive trainings for 60 minutes per day, two days per week for 16 sessions. The content of VR training is the same as before. The control group is performing traditional cognitive training program. The primary cognitive outcome measurements will include the Montreal Cognitive Assessment, Wechsler Memory Scale, Stroop test, and color trials test. Other outcomes will include measurements that evaluate the cognitive, daily functions, and quality of life of elderly with MCI and SCD. Participants will be assessed at baseline, after the intervention, and at 3-month follow-up. Repeated measures of analysis of variance (ANOVA) will be used to evaluate the changes in outcome measures at three different time points.

The investigators anticipate the VR training can facilitate cognitive function, daily function, and quality of life. The significance of this study is identifying the effect of immersive VR cognitive training based on leisure activities, and it is appropriate to provide this training for elderly with MCI and SCD. It could delay and prevent the progression to dementia and lead the field of technological assistance to new opportunities for training.

Eligibility criteria: MCI Inclusion Criteria:

* age range from 60 to 90 years
* self- or informant-reported memory or cognitive complaint.
* able to follow instruction
* MMSE score \<26
* dose not have dementia.

SCD Inclusion Criteria:

* age range from 60 to 90 years;
* MMSE\>=26;
* ECog-12 score \>1;
* 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, posttest (around 12 weeks after baseline)
measure: Change scores of the Wechsler Memory Scale - Third Edition (WMS-III)
timeFrame: baseline, posttest (around 12 weeks after baseline)
measure: Change scores of Stroop Color-Word Test
timeFrame: baseline, posttest (around 12 weeks after baseline)
Secondary outcomes:
measure: Change scores of the Wechsler Adult Intelligence Scale (WAIS)
timeFrame: baseline, posttest (around 12 weeks after baseline)
measure: Change scores of the Everyday Cognition scales (ECog)-12 items
timeFrame: baseline, posttest (around 12 weeks after baseline)
measure: Change scores of the Lawton Instrumental Activities of Daily Living Scale (IADL)
timeFrame: baseline, posttest (around 12 weeks after baseline)
measure: Change scores of the WHOQOL-BREF Taiwan Version
timeFrame: baseline, posttest (around 12 weeks after baseline)
measure: Change scores of Geriatric Depression Scale (GDS)
timeFrame: baseline, posttest (around 12 weeks after baseline)
measure: Change scores of The Chinese Aging Well Profile (CAWP)
timeFrame: baseline, posttest (around 12 weeks after baseline)
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
affiliation: Chang Gung Memorial Hospital
name: I-Ching Chuan, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: