Cognitive DysfunctionNCT04984694

Computerized Virtual Reality in Elderly

A study testing Computerized virtual reality training programs group (Hot-Plus group) and Social interaction group in people with Cognitive Dysfunction and Cognitive Change, run by Taipei Medical University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Cognitive Dysfunction, Cognitive Change, Independent Living
What is being tested?: Computerized virtual reality training programs group (Hot-Plus group) and Social interaction group
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteTaiwan
Study dates: 3 Feb 2017to 6 Mar 2019
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

TMU-Shuang-Ho Hospital, Taipei Medical University
New Taipei City, 23561

Other trials in Taiwan

About this study

Official title: Evaluation of Computerized Virtual Reality on FunctionalAbility and Quality of Life in Elderly

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.

Read the 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.

Conditions: Cognitive Dysfunction, Cognitive Change, Independent Living, Quality of Life, Video Games
Being tested: Computerized virtual reality training programs group (Hot-Plus group), Social interaction group
Keywords: cognitive dysfunction, computer-assisted instruction, independent living, video games, quality of life
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computerized virtual reality training programs group (Hot-Plus group)Behavioural
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.
Social interaction groupBehavioural
The social interaction group will get together as a group for social interaction one hour weekly for 12 weeks.

Study groups in NCT04984694
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Social interaction group
Control group	No intervention	The control group will maintain regular activities.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At 24 weeks after intervention.

Secondary outcomes (40)

Physical function-IADL
Instrumental Activities of Daily Living (IADL) were evaluated with eight abilities, including shopping, transportation, meal preparation, ordinary housework, doing laundry, medications, phone use, and managing finances. Individual items are summed to produce a scale that ranges from 0 to 8 (Lawton, \& Brody; 1969; Pashmdarfard \& Azad, 2020).
Measured: At baseline.
Physical function-IADL
IADL was evaluated with eight abilities including shopping, transportation, meal preparation, ordinary housework, doing laundry, medications, phone use, and managing finances. Individual items are summed to produce a scale that ranges from 0 to 8 (Lawton, \& Brody; 1969; Pashmdarfard \& Azad, 2020).
Measured: Immediately after intervention.
Physical function-IADL
IADL was evaluated with eight abilities including shopping, transportation, meal preparation, ordinary housework, doing laundry, medications, phone use, and managing finances. Individual items are summed to produce a scale that ranges from 0 to 8 (Lawton, \& Brody; 1969; Pashmdarfard \& Azad, 2020).
Measured: At 4 weeks after intervention.
Physical function-IADL
IADL was evaluated with eight abilities including shopping, transportation, meal preparation, ordinary housework, doing laundry, medications, phone use, and managing finances. Individual items are summed to produce a scale that ranges from 0 to 8 (Lawton, \& Brody; 1969; Pashmdarfard \& Azad, 2020).
Measured: At 12 weeks after intervention.
Physical function-IADL
IADL was evaluated with eight abilities including shopping, transportation, meal preparation, ordinary housework, doing laundry, medications, phone use, and managing finances. Individual items are summed to produce a scale that ranges from 0 to 8 (Lawton, \& Brody; 1969; Pashmdarfard \& Azad, 2020).
Measured: At 24 weeks after intervention.
Physical function-senior fitness test (SFT)
A series of functional test include chair stand test, 8-ft up and go test, chair sit and reach test, 6-min walk test, and unipedal stance test was developed by Rikli \& Jones.
It has good reliability and validity and test-retest reliability is above 0.9 (Rikli \& Jones, 2001).
Measured: At baseline.
Physical function-senior fitness test (SFT)
A series of functional test include chair stand test, 8-ft up and go test, chair sit and reach test, 6-min walk test, and unipedal stance test was developed by Rikli \& Jones.
It has good reliability and validity and test-retest reliability is above 0.9 (Rikli \& Jones, 2001).
Measured: Immediately after intervention.
Physical function-senior fitness test (SFT)
A series of functional test include chair stand test, 8-ft up and go test, chair sit and reach test, 6-min walk test, and unipedal stance test was developed by Rikli \& Jones.
It has good reliability and validity and test-retest reliability is above 0.9 (Rikli \& Jones, 2001).
Measured: At 4 weeks after intervention.
Physical function-senior fitness test (SFT)
A series of functional test include chair stand test, 8-ft up and go test, chair sit and reach test, 6-min walk test, and unipedal stance test was developed by Rikli \& Jones.
It has good reliability and validity and test-retest reliability is above 0.9 (Rikli \& Jones, 2001).
Measured: At 12 weeks after intervention.
Physical function-senior fitness test (SFT)
A series of functional test include chair stand test, 8-ft up and go test, chair sit and reach test, 6-min walk test, and unipedal stance test was developed by Rikli \& Jones.
It has good reliability and validity and test-retest reliability is above 0.9 (Rikli \& Jones, 2001).
Measured: At 24 weeks after intervention.
Physical function-unipedal stance test (UST)
Unipedal stance test was used to examine the static balance on the preferred leg. Participants performed three trials with the eyes open during the test (Goldberg, Casby, \& Wasielewski, 2011) .
Measured: At baseline.
Physical function-unipedal stance test (UST)
Unipedal stance test was used to examine the static balance on the preferred leg. Participants performed three trials with the eyes open during the test (Goldberg, Casby, \& Wasielewski, 2011) .
Measured: Immediately after intervention.
Physical function-unipedal stance test (UST)
Unipedal stance test was used to examine the static balance on the preferred leg. Participants performed three trials with the eyes open during the test (Goldberg, Casby, \& Wasielewski, 2011) .
Measured: At 4 weeks after intervention.
Physical function-unipedal stance test (UST)
Unipedal stance test was used to examine the static balance on the preferred leg. Participants performed three trials with the eyes open during the test (Goldberg, Casby, \& Wasielewski, 2011) .
Measured: At 12 weeks after intervention.
Physical function-unipedal stance test (UST)
Unipedal stance test was used to examine the static balance on the preferred leg. Participants performed three trials with the eyes open during the test (Goldberg, Casby, \& Wasielewski, 2011) .
Measured: At 24 weeks after intervention.
Psychosocial factors-Global Well-Being Scale (GWBS)
Global Well-Being Scale (GWBS): It is a 10-centimeter visual analog scale to measures individuals' perception of well-being. The score of GWBS ranged from 0 to 10 (Hawk et al., 2010).
Analog Scale (VAS) with a ten-centimeter horizontal line (Hawk et al., 2010).
Measured: At baseline.
Psychosocial factors-Global Well-Being Scale (GWBS)
Global Well-Being Scale (GWBS): It is a 10-centimeter visual analog scale to measures individuals' perception of well-being. The score of GWBS ranged from 0 to 10 (Hawk et al., 2010).
Analog Scale (VAS) with a ten-centimeter horizontal line (Hawk et al., 2010).
Measured: Immediately after intervention.
Psychosocial factors-Global Well-Being Scale (GWBS)
Global Well-Being Scale (GWBS): It is a 10-centimeter visual analog scale to measures individuals' perception of well-being. The score of GWBS ranged from 0 to 10 (Hawk et al., 2010).
Analog Scale (VAS) with a ten-centimeter horizontal line (Hawk et al., 2010).
Measured: At 4 weeks after intervention.
Psychosocial factors-Global Well-Being Scale (GWBS)
Global Well-Being Scale (GWBS): It is a 10-centimeter visual analog scale to measures individuals' perception of well-being. The score of GWBS ranged from 0 to 10 (Hawk et al., 2010).
Analog Scale (VAS) with a ten-centimeter horizontal line (Hawk et al., 2010).
Measured: At 12 weeks after intervention.
Psychosocial factors-Global Well-Being Scale (GWBS)
Global Well-Being Scale (GWBS): It is a 10-centimeter visual analog scale to measures individuals' perception of well-being. The score of GWBS ranged from 0 to 10 (Hawk et al., 2010).
Analog Scale (VAS) with a ten-centimeter horizontal line (Hawk et al., 2010).
Measured: At 24 weeks after intervention.
Psychosocial factors-Interpersonal Relationship Scale (IRS)
This scale was developed by Chang and Su (2011) in order to know the interpersonal relationship for middle-aged and older Adults.
It's composed of 22 questions related to the interpersonal relationship: close interaction, approach to others, and friendship support (Chang \& Su, 2011).
Measured: At baseline.
Psychosocial factors-Interpersonal Relationship Scale (IRS)
This scale was developed by Chang and Su (2011) in order to know the interpersonal relationship for middle-aged and older Adults.
It's composed of 22 questions related to the interpersonal relationship: close interaction, approach to others, and friendship support (Chang \& Su, 2011).
Measured: Immediately after intervention.
Psychosocial factors-Interpersonal Relationship Scale (IRS)
This scale was developed by Chang and Su (2011) in order to know the interpersonal relationship for middle-aged and older Adults.
It's composed of 22 questions related to the interpersonal relationship: close interaction, approach to others, and friendship support (Chang \& Su, 2011).
Measured: At 4 weeks after intervention.
Psychosocial factors-Interpersonal Relationship Scale (IRS)
This scale was developed by Chang and Su (2011) in order to know the interpersonal relationship for middle-aged and older Adults.
It's composed of 22 questions related to the interpersonal relationship: close interaction, approach to others, and friendship support (Chang \& Su, 2011).
Measured: At 12 weeks after intervention.
Psychosocial factors-Interpersonal Relationship Scale (IRS)
This scale was developed by Chang and Su (2011) in order to know the interpersonal relationship for middle-aged and older Adults.
It's composed of 22 questions related to the interpersonal relationship: close interaction, approach to others, and friendship support (Chang \& Su, 2011).
Measured: At 24 weeks after intervention.
Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)
Chinese version of the GDS-S consisted 15 items with yes/no questions and higher scores indicate a more severe level of depression (Lu, Liu, \& Yu, 1998; Pfeiffer, 1975).
Measured: At baseline.
Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)
Chinese version of the GDS-S consisted 15 items with yes/no questions and higher scores indicate a more severe level of depression (Lu, Liu, \& Yu, 1998; Pfeiffer, 1975).
Measured: Immediately after intervention.
Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)
Chinese version of the GDS-S consisted 15 items with yes/no questions and higher scores indicate a more severe level of depression (Lu, Liu, \& Yu, 1998; Pfeiffer, 1975).
Measured: At 4 weeks after intervention.
Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)
Chinese version of the GDS-S consisted 15 items with yes/no questions and higher scores indicate a more severe level of depression (Lu, Liu, \& Yu, 1998; Pfeiffer, 1975).
Measured: At 12 weeks after intervention.
Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)
Chinese version of the GDS-S consisted 15 items with yes/no questions and higher scores indicate a more severe level of depression (Lu, Liu, \& Yu, 1998; Pfeiffer, 1975).
Measured: At 24 weeks after intervention.
Quality of Life-EQ5D-Utility
EQ-5D-3L Taiwanese version questionnaire was selected to measure health-related quality of life (HRQOL) which was recommended in older adults and people with mild dementia (Aguirre, Kang, Hoare, Edwards, \& Orrell, 2016; León-Salas et al., 2015). According to the self-report index scores, it can be converted to a single summary utility score by using the time trade-off (TTO) technique. The range of this EQ-5D-3L utility score (EQ5D-Utility) was -0.67 to 1.00 by using the Taiwanese value set (Lee et al., 2013), as the score closer to 1 indicated the better health, a negative score indicated worse than dead, and a 0.5 score could be acceptable.
Measured: At baseline.
Quality of Life-EQ5D-Utility
EQ-5D-3L Taiwanese version questionnaire was selected to measure health-related quality of life (HRQOL) which was recommended in older adults and people with mild dementia (Aguirre, Kang, Hoare, Edwards, \& Orrell, 2016; León-Salas et al., 2015). According to the self-report index scores, it can be converted to a single summary utility score by using the time trade-off (TTO) technique. The range of this EQ-5D-3L utility score (EQ5D-Utility) was -0.67 to 1.00 by using the Taiwanese value set (Lee et al., 2013), as the score closer to 1 indicated the better health, a negative score indicated worse than dead, and a 0.5 score could be acceptable.
Measured: Immediately after intervention.
Quality of Life-EQ5D-Utility
EQ-5D-3L Taiwanese version questionnaire was selected to measure health-related quality of life (HRQOL) which was recommended in older adults and people with mild dementia (Aguirre, Kang, Hoare, Edwards, \& Orrell, 2016; León-Salas et al., 2015). According to the self-report index scores, it can be converted to a single summary utility score by using the time trade-off (TTO) technique. The range of this EQ-5D-3L utility score (EQ5D-Utility) was -0.67 to 1.00 by using the Taiwanese value set (Lee et al., 2013), as the score closer to 1 indicated the better health, a negative score indicated worse than dead, and a 0.5 score could be acceptable.
Measured: At 4 weeks after intervention.
Quality of Life-EQ5D-Utility
EQ-5D-3L Taiwanese version questionnaire was selected to measure health-related quality of life (HRQOL) which was recommended in older adults and people with mild dementia (Aguirre, Kang, Hoare, Edwards, \& Orrell, 2016; León-Salas et al., 2015). According to the self-report index scores, it can be converted to a single summary utility score by using the time trade-off (TTO) technique. The range of this EQ-5D-3L utility score (EQ5D-Utility) was -0.67 to 1.00 by using the Taiwanese value set (Lee et al., 2013), as the score closer to 1 indicated the better health, a negative score indicated worse than dead, and a 0.5 score could be acceptable.
Measured: At 12 weeks after intervention.
Quality of Life-EQ5D-Utility
EQ-5D-3L Taiwanese version questionnaire was selected to measure health-related quality of life (HRQOL) which was recommended in older adults and people with mild dementia (Aguirre, Kang, Hoare, Edwards, \& Orrell, 2016; León-Salas et al., 2015). According to the self-report index scores, it can be converted to a single summary utility score by using the time trade-off (TTO) technique. The range of this EQ-5D-3L utility score (EQ5D-Utility) was -0.67 to 1.00 by using the Taiwanese value set (Lee et al., 2013), as the score closer to 1 indicated the better health, a negative score indicated worse than dead, and a 0.5 score could be acceptable.
Measured: At 24 weeks after intervention.
Quality of Life-EQ5D-visual analogue scale
A 20-cm visual analogue scale in which respondents are asked to rate their current health status ranging from 0 (Worst imaginable health state) to 100 (Chang et al., 2007; EuroQol Research Foundation, 2018).
Measured: At baseline.
Quality of Life-EQ5D-visual analogue scale
A 20-cm visual analogue scale in which respondents are asked to rate their current health status ranging from 0 (Worst imaginable health state) to 100 (Chang et al., 2007; EuroQol Research Foundation, 2018).
Measured: Immediately after intervention.
Quality of Life-EQ5D-visual analogue scale
A 20-cm visual analogue scale in which respondents are asked to rate their current health status ranging from 0 (Worst imaginable health state) to 100 (Chang et al., 2007; EuroQol Research Foundation, 2018).
Measured: At 4 weeks after intervention.
Quality of Life-EQ5D-visual analogue scale
A 20-cm visual analogue scale in which respondents are asked to rate their current health status ranging from 0 (Worst imaginable health state) to 100 (Chang et al., 2007; EuroQol Research Foundation, 2018).
Measured: At 12 weeks after intervention.
Quality of Life-EQ5D-visual analogue scale
A 20-cm visual analogue scale in which respondents are asked to rate their current health status ranging from 0 (Worst imaginable health state) to 100 (Chang et al., 2007; EuroQol Research Foundation, 2018).
Measured: At 24 weeks after intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 20176 Mar 2019

First posted30 Jul 2021
Study start3 Feb 2017
Primary completion21 Nov 2018
Study completion6 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Cognitive DysfunctionStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04984694
Sponsor's protocol ID: MOST 105-2314-B-038 -063 -MY2
Status last verified: Nov 2016
First submitted: 16 Jul 2021
Last updated: 30 Jul 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Supreme Investment. Interactive health service system. Supreme Investment website. https://supremeinvest.co/hotplus/. Updated 2016. Accessed March 17, 2017.
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.
PubMed 1202204
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.
PubMed 2771064
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.
PubMed 8164812
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.
PubMed 12297574
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.
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.
PubMed 16367401
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.
PubMed 32617272
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.
PubMed 5349366
Rikli RE, Jones CJ. Senior Fitness Test Manual. Champaign: Human Kinetics; 2001.
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.
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.
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.
PubMed 9772013
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.
PubMed 1159263
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.
PubMed 24183199

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
Not yet recruitingObservational study
EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Active, not recruiting
EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders

All Cognitive Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Computerized Virtual Reality on FunctionalAbility and Quality of Life in Elderly
ClinicalTrials.gov ID: NCT04984694
Acronym / sponsor ID: MOST 105-2314-B-038 -063 -MY2
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Taipei Medical UniversityUniversity, hospital or other
Collaborators: Ministry of Science and Technology, Taiwan
Study start: 3 Feb 2017 (actual)
Primary completion: 21 Nov 2018 (actual)
Study completion: 6 Mar 2019 (actual)
First posted: 30 Jul 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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
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.

Arm	Type	Receives
Computerized virtual reality training programs group (Hot-Plus group)	Experimental	Behavioral: Computerized virtual reality training programs group (Hot-Plus group)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.
Social interaction group	Active comparator	Behavioral: Social interaction groupThe participants in the social interaction group will come as a group for social interaction one hour weekly for 12 weeks.
Control group	No intervention	–The control group will maintain regular activities.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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

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
Computerized virtual reality training programs group (Hot-Plus group)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.	Behavioural	Computerized virtual reality training programs group (Hot-Plus group)
Social interaction groupThe social interaction group will get together as a group for social interaction one hour weekly for 12 weeks.	Behavioural	Social interaction group

Primary outcome

Cognition-Global cognition
Time frame: At baseline.
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).
Cognition-Global cognition
Time frame: Immediately after intervention.
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).
Cognition-Global cognition
Time frame: At 4 weeks after intervention.
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).
Cognition-Global cognition
Time frame: At 12 weeks after intervention.
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).
Cognition-Global cognition
Time frame: At 24 weeks after intervention.
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).
Cognition-memory
Time frame: At baseline.
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.
Cognition-memory
Time frame: Immediately after intervention.
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.
Cognition-memory
Time frame: At 4 weeks after intervention.
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.
Cognition-memory
Time frame: At 12 weeks after intervention.
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.
Cognition-memory
Time frame: At 24 weeks after intervention.
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.
Cognition-attention
Time frame: At baseline.
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.
Cognition-attention
Time frame: Immediately after intervention.
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.
Cognition-attention
Time frame: At 4 weeks after intervention.
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.
Cognition-attention
Time frame: At 12 weeks after intervention.
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.
Cognition-attention
Time frame: At 24 weeks after intervention.
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.
Cognition-visual/spatial function
Time frame: At baseline.
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).
Cognition-visual/spatial function
Time frame: Immediately after intervention.
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).
Cognition-visual/spatial function
Time frame: At 4 weeks after intervention.
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).
Cognition-visual/spatial function
Time frame: At 12 weeks after intervention.
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).
Cognition-visual/spatial function
Time frame: At 24 weeks after intervention.
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).
Cognition-executive function
Time frame: At baseline.
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).
Cognition-executive function
Time frame: Immediately after intervention.
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).
Cognition-executive function
Time frame: At 4 weeks after intervention.
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).
Cognition-executive function
Time frame: At 12 weeks after intervention.
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).
Cognition-executive function
Time frame: At 24 weeks after intervention.
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).

40 secondary outcomes

Physical function-IADL
Time frame: At baseline.
Physical function-IADL
Time frame: Immediately after intervention.
Physical function-IADL
Time frame: At 4 weeks after intervention.
Physical function-IADL
Time frame: At 12 weeks after intervention.
Physical function-IADL
Time frame: At 24 weeks after intervention.
Physical function-senior fitness test (SFT)
Time frame: At baseline.
Physical function-senior fitness test (SFT)
Time frame: Immediately after intervention.
Physical function-senior fitness test (SFT)
Time frame: At 4 weeks after intervention.
Physical function-senior fitness test (SFT)
Time frame: At 12 weeks after intervention.
Physical function-senior fitness test (SFT)
Time frame: At 24 weeks after intervention.
Physical function-unipedal stance test (UST)
Time frame: At baseline.
Physical function-unipedal stance test (UST)
Time frame: Immediately after intervention.
Physical function-unipedal stance test (UST)
Time frame: At 4 weeks after intervention.
Physical function-unipedal stance test (UST)
Time frame: At 12 weeks after intervention.
Physical function-unipedal stance test (UST)
Time frame: At 24 weeks after intervention.
Psychosocial factors-Global Well-Being Scale (GWBS)
Time frame: At baseline.
Psychosocial factors-Global Well-Being Scale (GWBS)
Time frame: Immediately after intervention.
Psychosocial factors-Global Well-Being Scale (GWBS)
Time frame: At 4 weeks after intervention.
Psychosocial factors-Global Well-Being Scale (GWBS)
Time frame: At 12 weeks after intervention.
Psychosocial factors-Global Well-Being Scale (GWBS)
Time frame: At 24 weeks after intervention.
Psychosocial factors-Interpersonal Relationship Scale (IRS)
Time frame: At baseline.
Psychosocial factors-Interpersonal Relationship Scale (IRS)
Time frame: Immediately after intervention.
Psychosocial factors-Interpersonal Relationship Scale (IRS)
Time frame: At 4 weeks after intervention.
Psychosocial factors-Interpersonal Relationship Scale (IRS)
Time frame: At 12 weeks after intervention.
Psychosocial factors-Interpersonal Relationship Scale (IRS)
Time frame: At 24 weeks after intervention.
Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)
Time frame: At baseline.
Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)
Time frame: Immediately after intervention.
Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)
Time frame: At 4 weeks after intervention.
Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)
Time frame: At 12 weeks after intervention.
Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)
Time frame: At 24 weeks after intervention.
Quality of Life-EQ5D-Utility
Time frame: At baseline.
Quality of Life-EQ5D-Utility
Time frame: Immediately after intervention.
Quality of Life-EQ5D-Utility
Time frame: At 4 weeks after intervention.
Quality of Life-EQ5D-Utility
Time frame: At 12 weeks after intervention.
Quality of Life-EQ5D-Utility
Time frame: At 24 weeks after intervention.
Quality of Life-EQ5D-visual analogue scale
Time frame: At baseline.
Quality of Life-EQ5D-visual analogue scale
Time frame: Immediately after intervention.
Quality of Life-EQ5D-visual analogue scale
Time frame: At 4 weeks after intervention.
Quality of Life-EQ5D-visual analogue scale
Time frame: At 12 weeks after intervention.
Quality of Life-EQ5D-visual analogue scale
Time frame: At 24 weeks after intervention.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
BackgroundSupreme Investment. Interactive health service system. Supreme Investment website. https://supremeinvest.co/hotplus/. Updated 2016. Accessed March 17, 2017.
Background: PubMed 1202204Folstein 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.
Background: PubMed 2771064Morris 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.
Background: PubMed 8164812Welsh 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.
Background: PubMed 12297574Powlishta 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.
BackgroundShulman 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: PubMed 16367401Golden 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.
Background: PubMed 32617272Pashmdarfard 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.
Background: PubMed 5349366Lawton 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.
BackgroundRikli RE, Jones CJ. Senior Fitness Test Manual. Champaign: Human Kinetics; 2001.
BackgroundHawk 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.
BackgroundChang 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.

Related trials for Cognitive Dysfunction

RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
Not yet recruitingObservational study
EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Active, not recruiting
EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders

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.

Chia-Chi Chang, PhD principal investigator

Taipei Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jul 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognition-Global cognition (time frame: At baseline.). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04984694, which also lists 17 linked publications.

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 30 Jul 2021.