Clinical trial NCT04984694: Computerized Virtual Reality in Elderly
Official title: Evaluation of Computerized Virtual Reality on FunctionalAbility and Quality of Life in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Dysfunction
Cognitive Change
Independent Living
Quality of Life
Video Games
Keywords: cognitive dysfunction
computer-assisted instruction
independent living
video games
quality of life
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2021-07-30
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment A type of intervention model describing a clinical trial in which two or more groups of participants receive different interventions. For example, a three-arm parallel assignment involves three groups of participants. One group receives intervention (Computerized Virtual Reality program), one group receives social interaction, and the other group is the control group. So during the trial, participants in one group receive intervention "in parallel" to participants in the other group, who receive social interaction.
Primary purpose: PREVENTION

Brief summary: The number of dementia patients increased with aging population. People with subjective memory complaints or mild cognitive impairment (MCI) may have a high risk of developing dementia. Cognitive /memory training programs have shown the potential positive effects for improving or maintaining the cognitive progression. However, the impact of those cognitive progressions on functional ability and quality of life is not well understood. In addition, it appears to have large variability responsiveness among trained subjects. Most studies did not examine the individual difference associated with training. The major aim will evaluate the cognitive training programs on functional ability and quality of life in older adults. The results will be expected to understand the effectiveness of the computerized virtual reality training, improving or maintaining cognition, physical and psychosocial function, enhancing quality of life, and reducing the risk of developing disability even conversion into dementia in later life.

Detailed description: Prevention strategies for dementia are needed because of the increasing prevalence of dementia. People with mild cognitive impairment are at high risk of developing a disability, even conversion into dementia in later life. Cognitive /memory training programs have shown the potential positive effects for improving or maintaining the cognitive progression. However, the impact of those cognitive progressions on functional ability and quality of life is not well understood. The major aim of this total project is to evaluate the short and long-term effects of computerized virtual reality training programs (Xavix Hot-Plus) on functional ability (cognition, physical and psychosocial function) and quality of life in older adults with mild cognitive impairment.

The experimental research design with three groups, one pretest and four posttests will be conducted to examine the short-term and long-term effects on cognition (primary outcome), physical (secondary outcome), psychosocial function (secondary outcome), and quality of life (secondary outcome). Independent adults will be recruited from the community base on sample criteria. The total subjects will be 160 to 190 older adults and the community care centers include all eligible participants will be randomly assigned into computerized virtual reality training programs group (Hot-Plus group) or social interaction group. The subjects for the control group will be recruited in the community and be referred by neurological, psychiatric, or gerontological physicians.

Participants who are in the Hot-Plus group will divide several small groups which will be 4 persons with mild cognitive impairment. Participants will receive a computerized virtual reality training program by Hot-Plus as a group activity one hour, once a week for 12 weeks. The participants in the social interaction group will come as a group for social interaction one hour weekly for 12 weeks. The control group will maintain their regular activities.

Data will be analysed by using SPSS version 18.0 (SPSS, Chicago, IL), with the significance level is set at p\< .05. The normal distribution of the data will be evaluated using the Kolmogorov-Smirnov test. Mean, Standard deviation, frequency, and percentage will be performed to describe all variables. One-way analysis of variance (ANOVA) will be used to evaluate differences between groups according to the continuous variables, non-normal distribution of data will be calculated by Kruskasl-Wallis test. The chi-square test will be used for the comparison of categorical variables, and Fisher's exact test will be used due to the expected value less than four. Generalised Estimating Equation (GEE) will be used to examine the main effects, time effects, and interactions in outcomes over time.

The results will be expected to understand the effectiveness of the computerized virtual reality training, improving or maintaining cognition, physical, psychosocial function, enhancing quality of life, and reducing the risk of developing disability even conversion into dementia in later life.

Eligibility criteria: Inclusion Criteria:

* Equal to or older than 60 years old
* The SPMSQ scores range from 4-7 ( illiterate: 4-5, elementary: 5-6, junior high school: 6-7) or Clinical Dementia Rating Scale (CDR): 0.5
* Be able to communicate in Mandarin or Taiwanese
* Has the ability to see and hear well enough to follow the instructions
* Agree to participate in this study.

Exclusion Criteria:

* Activity restrictions from physician recommendation
* Unstable disease progress could affect their participation
* Surgery for joints or spinal cord within 6 months
* Unable to walk 50 meters with the assistant device
* Learning disability

Primary outcomes:
measure: Cognition-Global cognition
timeFrame: At baseline.
measure: Cognition-Global cognition
timeFrame: Immediately after intervention.
measure: Cognition-Global cognition
timeFrame: At 4 weeks after intervention.
measure: Cognition-Global cognition
timeFrame: At 12 weeks after intervention.
measure: Cognition-Global cognition
timeFrame: At 24 weeks after intervention.
measure: Cognition-memory
timeFrame: At baseline.
measure: Cognition-memory
timeFrame: Immediately after intervention.
measure: Cognition-memory
timeFrame: At 4 weeks after intervention.
measure: Cognition-memory
timeFrame: At 12 weeks after intervention.
measure: Cognition-memory
timeFrame: At 24 weeks after intervention.
measure: Cognition-attention
timeFrame: At baseline.
measure: Cognition-attention
timeFrame: Immediately after intervention.
measure: Cognition-attention
timeFrame: At 4 weeks after intervention.
measure: Cognition-attention
timeFrame: At 12 weeks after intervention.
measure: Cognition-attention
timeFrame: At 24 weeks after intervention.
measure: Cognition-visual/spatial function
timeFrame: At baseline.
measure: Cognition-visual/spatial function
timeFrame: Immediately after intervention.
measure: Cognition-visual/spatial function
timeFrame: At 4 weeks after intervention.
measure: Cognition-visual/spatial function
timeFrame: At 12 weeks after intervention.
measure: Cognition-visual/spatial function
timeFrame: At 24 weeks after intervention.
measure: Cognition-executive function
timeFrame: At baseline.
measure: Cognition-executive function
timeFrame: Immediately after intervention.
measure: Cognition-executive function
timeFrame: At 4 weeks after intervention.
measure: Cognition-executive function
timeFrame: At 12 weeks after intervention.
measure: Cognition-executive function
timeFrame: At 24 weeks after intervention.
Secondary outcomes:
measure: Physical function-IADL
timeFrame: At baseline.
measure: Physical function-IADL
timeFrame: Immediately after intervention.
measure: Physical function-IADL
timeFrame: At 4 weeks after intervention.
measure: Physical function-IADL
timeFrame: At 12 weeks after intervention.
measure: Physical function-IADL
timeFrame: At 24 weeks after intervention.
measure: Physical function-senior fitness test (SFT)
timeFrame: At baseline.
measure: Physical function-senior fitness test (SFT)
timeFrame: Immediately after intervention.
measure: Physical function-senior fitness test (SFT)
timeFrame: At 4 weeks after intervention.
measure: Physical function-senior fitness test (SFT)
timeFrame: At 12 weeks after intervention.
measure: Physical function-senior fitness test (SFT)
timeFrame: At 24 weeks after intervention.
measure: Physical function-unipedal stance test (UST)
timeFrame: At baseline.
measure: Physical function-unipedal stance test (UST)
timeFrame: Immediately after intervention.
measure: Physical function-unipedal stance test (UST)
timeFrame: At 4 weeks after intervention.
measure: Physical function-unipedal stance test (UST)
timeFrame: At 12 weeks after intervention.
measure: Physical function-unipedal stance test (UST)
timeFrame: At 24 weeks after intervention.
measure: Psychosocial factors-Global Well-Being Scale (GWBS)
timeFrame: At baseline.
measure: Psychosocial factors-Global Well-Being Scale (GWBS)
timeFrame: Immediately after intervention.
measure: Psychosocial factors-Global Well-Being Scale (GWBS)
timeFrame: At 4 weeks after intervention.
measure: Psychosocial factors-Global Well-Being Scale (GWBS)
timeFrame: At 12 weeks after intervention.
measure: Psychosocial factors-Global Well-Being Scale (GWBS)
timeFrame: At 24 weeks after intervention.
measure: Psychosocial factors-Interpersonal Relationship Scale (IRS)
timeFrame: At baseline.
measure: Psychosocial factors-Interpersonal Relationship Scale (IRS)
timeFrame: Immediately after intervention.
measure: Psychosocial factors-Interpersonal Relationship Scale (IRS)
timeFrame: At 4 weeks after intervention.
measure: Psychosocial factors-Interpersonal Relationship Scale (IRS)
timeFrame: At 12 weeks after intervention.
measure: Psychosocial factors-Interpersonal Relationship Scale (IRS)
timeFrame: At 24 weeks after intervention.
measure: Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)
timeFrame: At baseline.
measure: Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)
timeFrame: Immediately after intervention.
measure: Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)
timeFrame: At 4 weeks after intervention.
measure: Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)
timeFrame: At 12 weeks after intervention.
measure: Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)
timeFrame: At 24 weeks after intervention.
measure: Quality of Life-EQ5D-Utility
timeFrame: At baseline.
measure: Quality of Life-EQ5D-Utility
timeFrame: Immediately after intervention.
measure: Quality of Life-EQ5D-Utility
timeFrame: At 4 weeks after intervention.
measure: Quality of Life-EQ5D-Utility
timeFrame: At 12 weeks after intervention.
measure: Quality of Life-EQ5D-Utility
timeFrame: At 24 weeks after intervention.
measure: Quality of Life-EQ5D-visual analogue scale
timeFrame: At baseline.
measure: Quality of Life-EQ5D-visual analogue scale
timeFrame: Immediately after intervention.
measure: Quality of Life-EQ5D-visual analogue scale
timeFrame: At 4 weeks after intervention.
measure: Quality of Life-EQ5D-visual analogue scale
timeFrame: At 12 weeks after intervention.
measure: Quality of Life-EQ5D-visual analogue scale
timeFrame: At 24 weeks after intervention.
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: TMU-Shuang-Ho Hospital, Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Chia-Chi Chang, PhD
role: PRINCIPAL_INVESTIGATOR
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