Effects of the Fully Immersive Leisure-based Virtual Reality Cognitive Training for Community-dwelling Elderly

Virtual Reality Clinical Trial

Official title:

Effects of the Fully Immersive Leisure-based Virtual Reality Cognitive Training for Community-dwelling Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05227495
• Other study ID #: 202100553B0
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: Chang Gung Memorial Hospital
• Contact: Ching-yi Wu, ScD
• Phone: #886-3-2118800
• Email: cywu[@]mail.cgu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 community-dwelling elderly

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. age>=60

2. able to follow instruction

3. MMSE>=21

Exclusion Criteria:

1. dizziness or epilepsy history;

2. neurological or other orthopedic diseases with neurological or other orthopedic diseases (3)unstable physical condition of VR cognitive training; (4)Recent psychiatric diagnosis, such as depression

Related Conditions & MeSH terms

• Virtual Reality

Intervention

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 40 minutes. VR cognitive training receives four gardening activities. The cognitive elements including attention, working memory, processing speed, and executive function incorporated training.
• 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.

Locations

Country	Name	City	State
Taiwan	Chang Gung University	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, after the intervention eight weeks, and at 3-month follow-up.
Primary	Change scores of Wechsler Memory Scale (WMS)	Including Faces Recognition (total scale=48), Verbal Paired Associates (total scale = 32), Word Lists (total scale = 48), Memory Span (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, after the intervention eight weeks, and at 3-month follow-up.
Primary	Change scores of Stroop test	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. The time to complete the task will be calculated for each condition	baseline, after the intervention eight weeks, and at 3-month follow-up.
Primary	Change scores of Color trials test	For Part 1, the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2, the respondent rapidly connects numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.	baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary	Change scores of 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	baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary	Change scores of 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.	baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary	Change scores of Amsterdam Instrumental Activity of Daily Living,A-IADL	The Amsterdam Instrumental Activity of Daily Living (A-IADL) is an adaptive and computerized questionnaire designed to assess impairments in instrumental activities of daily living (IADL) in (early) dementia. The questionnaire is completed by a caregiver, such as a relative or friend.; Each item has a 5-point scale response option (scored 0-4). The scoring of the Amsterdam Instrumental Activity of Daily Living is calculated using item response theory .Lower scores indicating poorer performance.	baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary	Change scores of the World Health Organization Quality of Life-Old(WHOQOL-OLD) Taiwan Version	The World Health Organization Quality of Life-Old questionnaires demonstrate acceptable psychometric performance in a convenience sample of Taiwan older people. It are valuable measures of Quality of Life-Old for use with older people.Time frame for assessment is the past two weeks.; The items are distributed into 4 domains (physical; psychological, social and environmental health) and 25 facets.	baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary	Change scores of Community Integration Questionnaire, CIQ	The community integration questionnaire (CIQ) was designed to assess home integration, social integration and productive activity in persons with acquired brain injury. The instrument consists of 15 items and can be completed by self report or with the assistance of a family member or caregiver familiar with the person's health status and social activities.	baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary	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.	baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary	Change scores of The Chinese Aging Well Profile (CAWP)	It comprised eight open-ended questions focusing on the meaning and interpretation of 'subjective well-being', e.g., 'Can you tell me what the important contributors to your well-being are?', 'Can you describe the important elements in your life that make you feel happy?', 'Can you describe the important elements in your life that you dislike?' and 'What does well-being personally mean to you?' To adapt the Aging Well Profile for a Chinese population in Taiwan was secured. It was agreed that the new version would be called the Chinese Aging Well Profile (CAWP).	baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary	Change scores of The Clinical Frailty Scale (CFS)	The Clinical Frailty Scale (CFS) is a judgement-based frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill). The aim of this scoping review is to identify and document the nature and extent of research evidence related to the CFS.	baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary	Change scores of Timed up and go (TUG)	The TUG assesses the dynamic balance ability and mobility. The participants will be required to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The time to complete the TUG test has been shown to be a good indicator to detect potential fallers in frail elderly (Podsiadlo & Richardson, 1991). The test-retest reliability of TUG on individuals with cognitive impairment was excellent (Blankevoort, van Heuvelen, & Scherder, 2013).	baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary	Change scores of 30 second chair stand test,CST	The 30 second sit-to-stand will be assessed to indicate the strength and endurance level of the lower extremities. The 30 second sit-to-stand was standardized to allow hand support during the rise to and descent from standing but required participants to let go of the armrests with each stand. The participants will be asked to stand up from a standardized chair and then sit down as many times as possible within 30 seconds. The feasibility and reliability of using sit-to-stand test in people with cognitive impairment have been established to be good.	baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary	Change scores of Grip strength	The investigator will use hand dynamometer to measure grip strength of both hands while the participant is seated, with the elbow at 90-degree flexion. The investigator will record the mean value of 3 attempts.; Grip strength was measured using a digital dynamometers method, which is a tool with an adjustable grip span, ranging from 3.5 to 7 cm and weighing from 5 to 100 kg with minimal difference around 0.1 kg . All the participants were in a sitting position with fully extended elbows . Then, the investigator measured Grip strength on the dominant hand after 2-3 minutes of resting.	baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary	Change scores of short physical performance battery,SPPB	The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests . It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.	baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary	Change scores of Reported Edmonton Frail Scale (REFS)	Reported Edmonton Frail Scale is an adaptation of Edmonton Frail Scale, that can be performed in less than 10 min by any healthcare professional. Reported Edmonton Frail Scale substitutes the last domain on Edmonton Frail Scale, the physical performance measure, with three self-assessed physical performance questions . This is ideal for use in busy cardiology clinics when patients are being assessed for suitability for intervention. Scoring for the Reported Edmonton Frail Scale range is 0 to18. Not Frail:0-5 ;Apparently Vulnerable:6-7; Mildly Frail:8-9;Moderate Frailty:10-11;Sever Frailty:12-18.	baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary	Change scores of WHOQOL-bref Taiwan Version	As with the standard WHOQOL-BREF questionnaires the WHOQOL-BREF Taiwan version was simplified from the WHOQOL long form for Taiwan. For the purpose of cross-cultural comparison, the first 26 items were the same as the standard WHOQOL-BREF, which was developed from global studies. In addition to the 26 items, we applied the psychometric criteria proposed by the WHOQOL Group to select two more items from each of the two new facets to form the WHOQOL-BREF Taiwan version using data from the same 1,068 subjects. The selection process used for national items is described in the Results section. Thus, the WHOQOL-BREF Taiwan version contains 28 items classified into the same four domains as the standard WHOQOL-BREF. The scale administration and scoring procedures are the same as for the WHOQOL long form except that the facet score is based on only one item.	baseline, after the intervention eight weeks, and at 3-month follow-up.