Effects of the Fully Immersive VR Cognitive Training Based on Leisure Activities for the Elderly With MCI and SCD.

May 13, 2021 updated by: Chang Gung Memorial Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VR group
Behavioral: VR cognitive training

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.
Active Comparator: control group
Behavioral: Traditional cognitive training

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, posttest (around 12 weeks after baseline)
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.
baseline, posttest (around 12 weeks after baseline)
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.
baseline, posttest (around 12 weeks after baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change scores of the Wechsler Adult Intelligence Scale (WAIS)
Time Frame: baseline, posttest (around 12 weeks after baseline)
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
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)
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.
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)
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).
baseline, posttest (around 12 weeks after baseline)
Change scores of the WHOQOL-BREF Taiwan Version
Time Frame: baseline, posttest (around 12 weeks after baseline)
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).
baseline, posttest (around 12 weeks after baseline)
Change scores of Geriatric Depression Scale (GDS)
Time Frame: baseline, posttest (around 12 weeks after baseline)
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.
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)
The 31-item Chinese Aging Well Profile comprised seven subscales-'physical', 'psychological', 'independence', 'learning & growth', 'material', 'environmental', and 'social' well-being.
baseline, posttest (around 12 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: I-Ching Chuan, Ph.D, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202002283B0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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