Evaluation of Computerized Virtual Reality on FunctionalAbility and Quality of Life in Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Cognition-Global cognition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors were blinded to the group allocation.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Computerized virtual reality training programs group (Hot-Plus group) (Behavioral)
Social interaction group
The participants in the social interaction group will come as a group for social interaction one hour weekly for 12 weeks.
干预措施: Social interaction group (Behavioral)
Control group
The control group will maintain regular activities.
结局指标
主要结局
Cognition-Global cognition
时间窗: 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-executive function
时间窗: 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).
Cognition-memory
时间窗: 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
时间窗: 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
时间窗: 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-Global cognition
时间窗: 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
时间窗: 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
时间窗: 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-attention
时间窗: 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-Global cognition
时间窗: 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-memory
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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-attention
时间窗: 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
时间窗: 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
时间窗: 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-visual/spatial function
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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-executive function
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Physical function-senior fitness test (SFT)(At 24 weeks after intervention.)
- Physical function-IADL(At 24 weeks after intervention.)
- Psychosocial factors-Interpersonal Relationship Scale (IRS)(At 24 weeks after intervention.)
- Quality of Life-EQ5D-visual analogue scale(At 24 weeks after intervention.)
- Physical function-unipedal stance test (UST)(At 24 weeks after intervention.)
- Psychosocial factors-Global Well-Being Scale (GWBS)(At 24 weeks after intervention.)
- Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)(At 24 weeks after intervention.)
- Quality of Life-EQ5D-Utility(At 24 weeks after intervention.)
- 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-senior fitness test (SFT)(At baseline.)
- Physical function-senior fitness test (SFT)(Immediately after intervention.)
- Physical function-senior fitness test (SFT)(At 4 weeks after intervention.)
- Physical function-senior fitness test (SFT)(At 12 weeks after intervention.)
- Physical function-unipedal stance test (UST)(At baseline.)
- Physical function-unipedal stance test (UST)(Immediately after intervention.)
- Physical function-unipedal stance test (UST)(At 4 weeks after intervention.)
- Physical function-unipedal stance test (UST)(At 12 weeks after intervention.)
- Psychosocial factors-Global Well-Being Scale (GWBS)(At baseline.)
- Psychosocial factors-Global Well-Being Scale (GWBS)(Immediately after intervention.)
- Psychosocial factors-Global Well-Being Scale (GWBS)(At 4 weeks after intervention.)
- Psychosocial factors-Global Well-Being Scale (GWBS)(At 12 weeks after intervention.)
- Psychosocial factors-Interpersonal Relationship Scale (IRS)(At baseline.)
- Psychosocial factors-Interpersonal Relationship Scale (IRS)(Immediately after intervention.)
- Psychosocial factors-Interpersonal Relationship Scale (IRS)(At 4 weeks after intervention.)
- Psychosocial factors-Interpersonal Relationship Scale (IRS)(At 12 weeks after intervention.)
- Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)(At baseline.)
- Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)(Immediately after intervention.)
- Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)(At 4 weeks after intervention.)
- Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)(At 12 weeks after intervention.)
- Quality of Life-EQ5D-Utility(At baseline.)
- Quality of Life-EQ5D-Utility(Immediately after intervention.)
- Quality of Life-EQ5D-Utility(At 4 weeks after intervention.)
- Quality of Life-EQ5D-Utility(At 12 weeks after intervention.)
- Quality of Life-EQ5D-visual analogue scale(At baseline.)
- Quality of Life-EQ5D-visual analogue scale(Immediately after intervention.)
- Quality of Life-EQ5D-visual analogue scale(At 4 weeks after intervention.)
- Quality of Life-EQ5D-visual analogue scale(At 12 weeks after intervention.)