NCT04984694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2019

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
Last Updated

July 30, 2021

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

July 16, 2021

Last Update Submit

July 21, 2021

Conditions

Cognitive DysfunctionCognitive ChangeIndependent LivingQuality of LifeVideo Games

Keywords

cognitive dysfunctioncomputer-assisted instructionindependent livingvideo gamesquality of life

Outcome Measures

Primary Outcomes (25)

  • Cognition-Global cognition

    Global cognition was measured by the Mini-Mental State Examination (MMSE), a modified version of a neuropsychological battery in the Consortium to Establish a Registry for Alzheimer's Disease (CERAD), which maximum score was 30 including orientation, memory, concentration, language, and praxis (Folstein, Folstein, \& McHugh, 1975; Morris et al., 1989).

    At baseline.

  • Cognition-Global cognition

    Global cognition was measured by the Mini-Mental State Examination (MMSE), a modified version of a neuropsychological battery in the Consortium to Establish a Registry for Alzheimer's Disease (CERAD), which maximum score was 30 including orientation, memory, concentration, language, and praxis (Folstein, Folstein, \& McHugh, 1975; Morris et al., 1989).

    Immediately after intervention.

  • Cognition-Global cognition

    Global cognition was measured by the Mini-Mental State Examination (MMSE), a modified version of a neuropsychological battery in the Consortium to Establish a Registry for Alzheimer's Disease (CERAD), which maximum score was 30 including orientation, memory, concentration, language, and praxis (Folstein, Folstein, \& McHugh, 1975; Morris et al., 1989).

    At 4 weeks after intervention.

  • Cognition-Global cognition

    Global cognition was measured by the Mini-Mental State Examination (MMSE), a modified version of a neuropsychological battery in the Consortium to Establish a Registry for Alzheimer's Disease (CERAD), which maximum score was 30 including orientation, memory, concentration, language, and praxis (Folstein, Folstein, \& McHugh, 1975; Morris et al., 1989).

    At 12 weeks after intervention.

  • Cognition-Global cognition

    Global cognition was measured by the Mini-Mental State Examination (MMSE), a modified version of a neuropsychological battery in the Consortium to Establish a Registry for Alzheimer's Disease (CERAD), which maximum score was 30 including orientation, memory, concentration, language, and praxis (Folstein, Folstein, \& McHugh, 1975; Morris et al., 1989).

    At 24 weeks after intervention.

  • Cognition-memory

    Memory was measured by the Word List test, contained three types as following (Morris et al., 1989; Welsh et al., 1994): 1) Immediately recall; 2) Delayed recall; 3) Recognition.

    At baseline.

  • Cognition-memory

    Memory was measured by the Word List test, contained three types as following (Morris et al., 1989; Welsh et al., 1994): 1) Immediately recall; 2) Delayed recall; 3) Recognition.

    Immediately after intervention.

  • Cognition-memory

    Memory was measured by the Word List test, contained three types as following (Morris et al., 1989; Welsh et al., 1994): 1) Immediately recall; 2) Delayed recall; 3) Recognition.

    At 4 weeks after intervention.

  • Cognition-memory

    Memory was measured by the Word List test, contained three types as following (Morris et al., 1989; Welsh et al., 1994): 1) Immediately recall; 2) Delayed recall; 3) Recognition.

    At 12 weeks after intervention.

  • Cognition-memory

    Memory was measured by the Word List test, contained three types as following (Morris et al., 1989; Welsh et al., 1994): 1) Immediately recall; 2) Delayed recall; 3) Recognition.

    At 24 weeks after intervention.

  • Cognition-attention

    Attention was measured by the Digit Span (DS) subtest from the Taiwan version of the Wechsler Adult Intelligence Scale-Ⅲ (WAIS-IV; Wechsler, 2002), which contained two components: DS forward and DS backward.

    At baseline.

  • Cognition-attention

    Attention was measured by the Digit Span (DS) subtest from the Taiwan version of the Wechsler Adult Intelligence Scale-Ⅲ (WAIS-IV; Wechsler, 2002), which contained two components: DS forward and DS backward.

    Immediately after intervention.

  • Cognition-attention

    Attention was measured by the Digit Span (DS) subtest from the Taiwan version of the Wechsler Adult Intelligence Scale-Ⅲ (WAIS-IV; Wechsler, 2002), which contained two components: DS forward and DS backward.

    At 4 weeks after intervention.

  • Cognition-attention

    Attention was measured by the Digit Span (DS) subtest from the Taiwan version of the Wechsler Adult Intelligence Scale-Ⅲ (WAIS-IV; Wechsler, 2002), which contained two components: DS forward and DS backward.

    At 12 weeks after intervention.

  • Cognition-attention

    Attention was measured by the Digit Span (DS) subtest from the Taiwan version of the Wechsler Adult Intelligence Scale-Ⅲ (WAIS-IV; Wechsler, 2002), which contained two components: DS forward and DS backward.

    At 24 weeks after intervention.

  • Cognition-visual/spatial function

    Visual/spatial function was measured by the Clock Drawing Test (CDT). Participants were asked to draw a clock face, place all the numbers on it, and set the time to 11 past 10 (Powlishta et al., 2002; Shulman, Shedletsky, \& Silver, 1986).

    At baseline.

  • Cognition-visual/spatial function

    Visual/spatial function was measured by the Clock Drawing Test (CDT). Participants were asked to draw a clock face, place all the numbers on it, and set the time to 11 past 10 (Powlishta et al., 2002; Shulman, Shedletsky, \& Silver, 1986).

    Immediately after intervention.

  • Cognition-visual/spatial function

    Visual/spatial function was measured by the Clock Drawing Test (CDT). Participants were asked to draw a clock face, place all the numbers on it, and set the time to 11 past 10 (Powlishta et al., 2002; Shulman, Shedletsky, \& Silver, 1986).

    At 4 weeks after intervention.

  • Cognition-visual/spatial function

    Visual/spatial function was measured by the Clock Drawing Test (CDT). Participants were asked to draw a clock face, place all the numbers on it, and set the time to 11 past 10 (Powlishta et al., 2002; Shulman, Shedletsky, \& Silver, 1986).

    At 12 weeks after intervention.

  • Cognition-visual/spatial function

    Visual/spatial function was measured by the Clock Drawing Test (CDT). Participants were asked to draw a clock face, place all the numbers on it, and set the time to 11 past 10 (Powlishta et al., 2002; Shulman, Shedletsky, \& Silver, 1986).

    At 24 weeks after intervention.

  • Cognition-executive function

    Executive function was measured by the Stroop Color and Word Test (SCWT)(Golden et al., 2002). It consisted of three subtasks: word reading (RED, GREEN, and BLUE), color naming (XXXX's colored in red, green, or blue ink), and incongruent color-word naming (the words RED, GREEN, and BLUE printed in not matching red, green, or blue ink).

    At baseline.

  • Cognition-executive function

    Executive function was measured by the Stroop Color and Word Test (SCWT)(Golden et al., 2002). It consisted of three subtasks: word reading (RED, GREEN, and BLUE), color naming (XXXX's colored in red, green, or blue ink), and incongruent color-word naming (the words RED, GREEN, and BLUE printed in not matching red, green, or blue ink).

    Immediately after intervention.

  • Cognition-executive function

    Executive function was measured by the Stroop Color and Word Test (SCWT)(Golden et al., 2002). It consisted of three subtasks: word reading (RED, GREEN, and BLUE), color naming (XXXX's colored in red, green, or blue ink), and incongruent color-word naming (the words RED, GREEN, and BLUE printed in not matching red, green, or blue ink).

    At 4 weeks after intervention.

  • Cognition-executive function

    Executive function was measured by the Stroop Color and Word Test (SCWT)(Golden et al., 2002). It consisted of three subtasks: word reading (RED, GREEN, and BLUE), color naming (XXXX's colored in red, green, or blue ink), and incongruent color-word naming (the words RED, GREEN, and BLUE printed in not matching red, green, or blue ink).

    At 12 weeks after intervention.

  • Cognition-executive function

    Executive function was measured by the Stroop Color and Word Test (SCWT)(Golden et al., 2002). It consisted of three subtasks: word reading (RED, GREEN, and BLUE), color naming (XXXX's colored in red, green, or blue ink), and incongruent color-word naming (the words RED, GREEN, and BLUE printed in not matching red, green, or blue ink).

    At 24 weeks after intervention.

Secondary Outcomes (40)

  • Physical function-IADL

    At baseline.

  • Physical function-IADL

    Immediately after intervention.

  • Physical function-IADL

    At 4 weeks after intervention.

  • Physical function-IADL

    At 12 weeks after intervention.

  • Physical function-IADL

    At 24 weeks after intervention.

  • +35 more secondary outcomes

Study Arms (3)

Computerized virtual reality training programs group (Hot-Plus group)

EXPERIMENTAL

Participants who are in Hot-Plus group will divide several small groups which will be 4 persons with mild cognitive impairment. Participants will receive computerized virtual reality training program by Hot-Plus as a group activity for one hour, once a week for 12 weeks.

Behavioral: Computerized virtual reality training programs group (Hot-Plus group)

Social interaction group

ACTIVE COMPARATOR

The participants in the social interaction group will come as a group for social interaction one hour weekly for 12 weeks.

Behavioral: Social interaction group

Control group

NO INTERVENTION

The control group will maintain regular activities.

Interventions

Computerized virtual reality training programs group (Hot-Plus group)BEHAVIORAL

In this study, the investigators utilised interactive-video games called "Xavix Hot Plus"(Hot-plus, Shinsedai\[SSD\] Co. Ltd, Shiga Japan), which was designed specifically for rehabilitation and reported high participant motivation and enjoyment while playing.

Computerized virtual reality training programs group (Hot-Plus group)
Social interaction groupBEHAVIORAL

The social interaction group will get together as a group for social interaction one hour weekly for 12 weeks.

Social interaction group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TMU-Shuang-Ho Hospital, Taipei Medical University

New Taipei City, 23561, Taiwan

Location

Related Publications (17)

  • Supreme Investment. Interactive health service system. Supreme Investment website. https://supremeinvest.co/hotplus/. Updated 2016. Accessed March 17, 2017.

    BACKGROUND

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PMID: 1202204BACKGROUND

  • Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65. doi: 10.1212/wnl.39.9.1159.

    PMID: 2771064BACKGROUND

  • Welsh KA, Butters N, Mohs RC, Beekly D, Edland S, Fillenbaum G, Heyman A. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part V. A normative study of the neuropsychological battery. Neurology. 1994 Apr;44(4):609-14. doi: 10.1212/wnl.44.4.609.

    PMID: 8164812BACKGROUND

  • Powlishta KK, Von Dras DD, Stanford A, Carr DB, Tsering C, Miller JP, Morris JC. The clock drawing test is a poor screen for very mild dementia. Neurology. 2002 Sep 24;59(6):898-903. doi: 10.1212/wnl.59.6.898.

    PMID: 12297574BACKGROUND

  • Shulman K, Shedletsky R, Silver I. The challenge of time: Clock-drawing and cognitive function in the elderly. Int J Geriat Psychiatry. 1986:1(2):135-140.

    BACKGROUND

  • Golden CJ. A group version of the Stroop Color and Word Test. J Pers Assess. 1975 Aug;39(4):386-8. doi: 10.1207/s15327752jpa3904_10.

    PMID: 16367401BACKGROUND

  • Pashmdarfard M, Azad A. Assessment tools to evaluate Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) in older adults: A systematic review. Med J Islam Repub Iran. 2020 Apr 13;34:33. doi: 10.34171/mjiri.34.33. eCollection 2020.

    PMID: 32617272BACKGROUND

  • Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.

    PMID: 5349366BACKGROUND

  • Rikli RE, Jones CJ. Senior Fitness Test Manual. Champaign: Human Kinetics; 2001.

    BACKGROUND

  • Hawk C, Dusio ME, Wallace H, Bernard T, Rexroth C. Development of a patient-centered instrument for the assessment of global well-being: a study of reliability, validity, and clinical responsiveness. Palmer J Res. 1995;2(1):15-22.

    BACKGROUND

  • Chang W J, Su MP. Exploring the effects of self-concept and interpersonal relationship who attends the music program for middle-aged and elderly adults in community. Journal of Community Research. 2011:2:109-157.

    BACKGROUND

  • Liu HC, Fuh JL, Wang SJ, Liu CY, Larson EB, Lin KN, Wang HC, Chou P, Wu ZA, Lin CH, Wang PN, Teng EL. Prevalence and subtypes of dementia in a rural Chinese population. Alzheimer Dis Assoc Disord. 1998 Sep;12(3):127-34. doi: 10.1097/00002093-199809000-00002.

    PMID: 9772013BACKGROUND

  • Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc. 1975 Oct;23(10):433-41. doi: 10.1111/j.1532-5415.1975.tb00927.x.

    PMID: 1159263BACKGROUND

  • Lee HY, Hung MC, Hu FC, Chang YY, Hsieh CL, Wang JD. Estimating quality weights for EQ-5D (EuroQol-5 dimensions) health states with the time trade-off method in Taiwan. J Formos Med Assoc. 2013 Nov;112(11):699-706. doi: 10.1016/j.jfma.2012.12.015. Epub 2013 Feb 12.

    PMID: 24183199BACKGROUND

  • Chang TJ, Tarn YH, Hsieh CL, Liou WS, Shaw JW, Chiou XG. Taiwanese version of the EQ-5D: validation in a representative sample of the Taiwanese population. J Formos Med Assoc. 2007 Dec;106(12):1023-31. doi: 10.1016/S0929-6646(08)60078-9.

    PMID: 18194908BACKGROUND

  • EuroQol Research Foundation. EQ-5D-3L User Guidet, 2018. https://euroqol.org/publications/user-guides/. Updated October, 2018. Accessed August 16, 2019.

    BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Chia-Chi Chang, PhD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors were blinded to the group allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2021

First Posted

July 30, 2021

Study Start

February 3, 2017

Primary Completion

November 21, 2018

Study Completion

March 6, 2019

Last Updated

July 30, 2021

Record last verified: 2016-11

Locations

TW(1)