MCINCT04779671
Effects of the Fully Immersive VR Cognitive Training Based on Leisure Activities for the Elderly With MCI and SCD.
A study testing VR cognitive training and Traditional cognitive training in people with MCI and SCD, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- MCI, SCD, Virtual Reality
- What is being tested?
- VR cognitive training and Traditional cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2021to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung University
Taoyuan, 333
I-Ching Chuang, PhD, #886-3-2118800 ext. 3954, ichin@mail.cgu.edu.tw
About this study
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.
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.
Read the 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.
- Conditions
- MCI, SCD, Virtual Reality
- Being tested
- VR cognitive training, Traditional cognitive training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR cognitive trainingBehavioural
All participants will receive trainings for 60 minutes per day, two days per week for 16 sessions.
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.
Traditional cognitive trainingBehavioural
All participants will receive trainings for 60 minutes per day, two days per week for 16 sessions.
The control group is performing traditional cognitive training program.
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | Not described Receives: Behavioral: VR cognitive training |
| control group | Active comparator | Not described Receives: Behavioral: Traditional cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of the Wechsler Memory Scale - Third Edition (WMS-III)
Several subtests of Wechsler Memory Scale - Third Edition (WMS-III) including Faces Recognition (total scale=48), Verbal Paired Associates (total scale = 32), Word Lists (total scale = 48), and Spatial Span (total scale=32) will be used to assess the immediate, delayed, and working memory tests. For each subtest, a higher number indicates better performance in memory function. The raw score of subtests will also be transferred to standardized Z scores and summed to represent an index of general memory function.
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of Stroop Color-Word Test
The Stroop Color-Word test assesses the abilities of selective attention, inhibition and executive function. The participants will be tested under congruent and incongruent conditions. In the congruent condition, the participant will name the color ink of a word which is consistent with the written color name; whereas in the incongruent condition the participant will name the color ink differs from the written color name. In both conditions, the number of colors correctly named within 45 seconds will be measured and the performance in the congruent condition will be compared with the incongruent condition.
Measured: baseline, posttest (around 12 weeks after baseline)
Secondary outcomes (6)
Change scores of the Wechsler Adult Intelligence Scale (WAIS)
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of the Everyday Cognition scales (ECog)-12 items
To detect cognitive and functional decline. The ECog shows promise as a useful tool for the measurement of general and domain-specific everyday functions in the elderly. There are six domains (Everyday Memory, Language, Visuospatial Abilities, Planning, Organization, and Divided Attention) in ECog. Lower scores represent a higher level of function in daily life.
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of the Lawton Instrumental Activities of Daily Living Scale (IADL)
Assess activities of daily living. There are 8 domains of function measured with the Lawton IADL scale, including ability to use phone,shopping, food preparation, housekeeping, laundering, mode of transportation, responsibility for own medications,and ability to handle finances. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent). For each category, circle the item description that most closely resembles the client's highest functional level (either 0 or 1).
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of the WHOQOL-BREF Taiwan Version
Exploratory and confirmatory factor analyses revealed a four-factor (physical, psychological, social, and environmental) model. The internal consistency (Cronbach's α) coefficients ranged from 0.70 to 0.77 for the four domains. The test-retest reliability coefficients with intervals of 2 to 4 weeks ranged from 0.41 to 0.79 at item/facet level and 0.76 to 0.80 at domain level (all p < 0.01). Content validity coefficients were in the range of 0.53 to 0.78 for item-domain correlations and 0.51 to 0.64 for inter-domain correlations (all p < 0.01). The four domains of the brief form can explain 88% of the variance of the total QOL score and 60% of the variance of the Facet G score (measuring overall quality of life and general health).
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of Geriatric Depression Scale (GDS)
The Geriatric Depression Scale (GDS) - 15 items version is a self-administered questionnaire used to evaluate mood and depressive symptoms. The scores range is 0-15 and a score of 5 or greater taken as a possible indicator of depression.
Measured: baseline, posttest (around 12 weeks after baseline)
Change scores of The Chinese Aging Well Profile (CAWP)
The 31-item Chinese Aging Well Profile comprised seven subscales-'physical', 'psychological', 'independence', 'learning \& growth', 'material', 'environmental', and 'social' well-being.
Measured: baseline, posttest (around 12 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study startOct 2021 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I-Ching Chuan, Ph.D, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779671
- Sponsor's protocol ID
- 202002283B0
- Status last verified
- May 2021
- First submitted
- 1 Mar 2021
- Last updated
- 17 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04779671
- Acronym / sponsor ID
- 202002283B0
- Conditions
- MCI, SCD, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Behavioral: VR cognitive training |
| control group | Active comparator | Behavioral: Traditional cognitive training |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR cognitive trainingAll participants will receive trainings for 60 minutes per day, two days per week for 16 sessions. 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. | Behavioural | VR group |
| Traditional cognitive trainingAll participants will receive trainings for 60 minutes per day, two days per week for 16 sessions. The control group is performing traditional cognitive training program. | Behavioural | control group |
Primary outcome
Change scores of the Montreal Cognitive Assessment (MoCA)
Time frame: baseline, posttest (around 12 weeks after baseline)
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.
Change scores of the Wechsler Memory Scale - Third Edition (WMS-III)
Time frame: baseline, posttest (around 12 weeks after baseline)
Several subtests of Wechsler Memory Scale - Third Edition (WMS-III) including Faces Recognition (total scale=48), Verbal Paired Associates (total scale = 32), Word Lists (total scale = 48), and Spatial Span (total scale=32) will be used to assess the immediate, delayed, and working memory tests. For each subtest, a higher number indicates better performance in memory function. The raw score of subtests will also be transferred to standardized Z scores and summed to represent an index of general memory function.
Change scores of Stroop Color-Word Test
Time frame: baseline, posttest (around 12 weeks after baseline)
The Stroop Color-Word test assesses the abilities of selective attention, inhibition and executive function. The participants will be tested under congruent and incongruent conditions. In the congruent condition, the participant will name the color ink of a word which is consistent with the written color name; whereas in the incongruent condition the participant will name the color ink differs from the written color name. In both conditions, the number of colors correctly named within 45 seconds will be measured and the performance in the congruent condition will be compared with the incongruent condition.
6 secondary outcomes
Change scores of the Wechsler Adult Intelligence Scale (WAIS)
Time frame: baseline, posttest (around 12 weeks after baseline)
Change scores of the Everyday Cognition scales (ECog)-12 items
Time frame: baseline, posttest (around 12 weeks after baseline)
Change scores of the Lawton Instrumental Activities of Daily Living Scale (IADL)
Time frame: baseline, posttest (around 12 weeks after baseline)
Change scores of the WHOQOL-BREF Taiwan Version
Time frame: baseline, posttest (around 12 weeks after baseline)
Change scores of Geriatric Depression Scale (GDS)
Time frame: baseline, posttest (around 12 weeks after baseline)
Change scores of The Chinese Aging Well Profile (CAWP)
Time frame: baseline, posttest (around 12 weeks after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Ching Chuan, Ph.D principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR cognitive training and Traditional cognitive training in people with MCI and SCD, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I-Ching Chuang, Ph.D (#886-3-2118800 ext. 3954, ichin@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores of the Montreal Cognitive Assessment (MoCA) (time frame: baseline, posttest (around 12 weeks after baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.