The Effects of Dual-Task Training on Global Cognitive Function, Executive Function, Working Memory, Sleep, Behavioral Disturbances, Balance, and Flexibility for People With Mild Cognitive Impairment and Mild Dementia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Global cognitive function
研究概览
简要总结
Evidence shows that people with dementia have a higher prevalence of sleep disturbance, cognitive decline, behavioral disturbance, and experience motor dysfunction. These symptoms are interrelated. However, few randomized controlled trial (RCT) studies implement dual-task training for mild cognitive impairment and mild dementia, especially for those who experience sleep problems and behavioral disturbances.
Therefore, this study aims to analyze the effect of dual-task training in improving global cognitive function, executive function, working memory, sleep, behavioral disturbances, balance, and flexibility among people with mild cognitive impairment and mild dementia.
The main questions it aims to answer are:
- . Does dual-task training affect primary outcomes (global cognitive function, executive function, and working memory)
- . Does dual-task training affect secondary outcomes (including sleep quality, behavioral disturbances, balance, and flexibility) for people with mild cognitive impairment and mild dementia?"
The length of dual-task training is 12 weeks; sessions are 3 times per week, each session lasts 45 minutes, and total sessions are 36. There are three groups of intervention (dual-task training, cognitive training, and motor training). While the control group receives the usual care. Researchers will compare the experiment and control groups to see the effect of the dual-task training.
详细描述
Sample size calculation: Investigators use the G*Power sample size calculator under an F test with an analysis of variance based on some criteria, for instance: effect size 0.2 (small), power 80%, four times measurement, four groups (cognitive training, motor training, dual-task training, and control group) and α error probability of 0.05. The sample size from the calculator yields 48 in total, considering 50% attrition rate, finally 72 participants (18 participants for each group) will be recruited.
Sample recruitment: Investigator will use a CONSORT flow diagram to describe the phases of this study. A purposive sampling technique will be used in this study to specifically select the nursing home. Following this, eligibility interviews and screening test using MMSE (The Mini Mental State Examination) and The Clinical Dementia Rating (CDR) will be used to recruit participants. The participants will be recruited in this study CDR score varies from 1 to 4, and MMSE >=18. Other inclusion criteria are complain of conscious cognitive decline, participate voluntarily and sign informed consent. However, potential participants will be excluded if they diagnosed with moderate or severe dementia, those who have received cognitive training or motor training within six months, people with severe sensory function impairment (such as vision, hearing), and with limited mobility, such as those using wheelchairs or four-legged walking aids.
Randomization and Blinding: The allocation of the group to be either the experimental (dual-task training group, cognitive training group, motor training group) or control group will be conducted using permuted block randomization design with a block size of four. Randomization was carried out using a web-based randomization tool by a third party who was not involved in the intervention team. To ensure the allocation concealment, investigators use SNOSE principle (sequentially numbered, opaque, sealed envelopes), and randomization code will not be released until the participant or interventionist has started the trial. This study adopts a single-blind approach, by blinding data collector.
Baseline Data Collection Procedure: Participants who meet the inclusion criteria and agree to participate, will be requested to complete a sociodemographic characteristic questionnaire and the seven outcome measures. However, the completion of the seven outcome measures will be conducted in two days to avoid boredom among the participants. In the first period, a sociodemographic questionnaire, WCST, DS, NPI-Q will be completed. The PSQI, ISI, SFBBS, Chair sit-and-reach test (CSR) and Back scratch test completion will be conducted later in the second day at a time agreed upon by the researcher and participants.
Intervention delivery: 1). The dual-task training is a combination of cognitive tasks and motor tasks. Motor task consist of six components, including: strength, balance, agility, gait, aerobic capacity, and flexibility. Whereas Cognitive task consists of four cognitive domains: attention, executive function, learning and memory, language, and perception motor. Both component will be delivered simultaneously or at the same time, and will be delivered in a group format, consisting of 8 to 10 participants for each group. The length of therapy is 12 weeks; sessions are 3 times per week, each session lasts 45 minutes (20 minutes first: cognitive tasks and motor tasks, 5 minutes break time (at this time, participants will be given drink and snack), 20 minutes second: cognitive tasks and motor tasks), and total sessions are 36. In this study, only one interventionist (the principal investigator) from the research team will deliver the intervention sessions. The detail description of each session are below: session 1-6: Participants initially receive one of two tasks (either a cognitive or motor task) and undergo training for each individually; session 7-12: participants receive cognitive and motor task at the same time; session 13-18: repetition of sessions 7 to 12, and session 19-36 are repetition from session 1 to 18. 2). Cognitive training= in this group, participants only receive cognitive training. 3). Motor training= in this group, participants only receive motor training. The duration are same with dual-task training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes Assessor will be blind, so they didnt know which is intervention group or control group
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older adult >= 60 years and able to communicate
- •CDR score range from 1 to 4
- •MMSE score >= 18
- •Complain of conscious cognitive decline.
- •Participate voluntarily and sign informed consent.
排除标准
- •Diagnosed with moderate or severe dementia.
- •Received cognitive training or motor training within six months.
- •Severe sensory function impairment (such as vision, and hearing).
- •Have limited mobility, such as those using wheelchairs or four-legged walking aids.
研究组 & 干预措施
Dual-task training
Participants in the experimental group will receive dual-task training, which consists of cognitive and motor task carried out at the same time. The length of therapy is 12 weeks; sessions are 3 times per week, each session lasts 45 minutes, and total sessions are 36.
干预措施: Dual-task training (Behavioral)
Cognitive training
Participants in this group receive cognitive training only. The length of therapy is 12 weeks; sessions are 3 times per week, each session lasts 45 minutes, and total sessions are 36.
干预措施: Cognitive training (Behavioral)
Motor training
Participants in this group receive motor training only. The length of therapy is 12 weeks; sessions are 3 times per week, each session lasts 45 minutes, and total sessions are 36.
干预措施: Motor training (Behavioral)
Usual
Participants in this group receive usual care provided by the nursing home staff, which typically includes assistance with activities of daily living, medication management, and social activities. They do not receive the structured physical exercise program.
干预措施: Usual care (Other)
结局指标
主要结局
Global cognitive function
时间窗: baseline, week 6, week 12, week 16
measured using MMSE that consists of five domains including orientation to time (5 points), orientation to place (5 points), registration (3 points), attention and calculation (5 points), recall (3 points), and language (9 points), ranges from 0 to 30. MMSE 0-17 scores indicating severe cognitive impairment, 18-23 mild cognitive impairment, and 24-30 as normal (no cognitive impairment).
Executive function
时间窗: baseline, week 6, week 12, week 16
measured with the Wisconsin card sort test (WCST). The result of the test is then categorized including: 1). number of completed categories (NCC), 2). total number of errors, 3). perseverative response (PR), 4). perseverative errors, 5). non-perseverative errors (NEs), 6). conceptual level responses (CLRs), 7). failure to maintain set, and 8). trials to complete the first category
Working memory
时间窗: baseline, week 6, week 12, week 16
measured using a Digit span (DS) test that comprises both digit forward (16 points) and digit backward (14 points). In the DS forward, the participant had to listen to a digit span that kept to the speed of one digit per second and repeat it forward. In contrast, to DS forward, in the DS backward, the participant had to listen and repeat the span backward. Span was taken as the maximum length if performed without error. However, if participants answered wrong 2 times consequently, the task ended and the number of correct answers was calculated as a score
次要结局
- Sleep Quality(baseline, week 6, week 12, week 16)
- Balance(baseline, week 6, week 12, week 16)
- Behavioral disturbance(baseline, week 6, week 12, week 16)
- Flexibility(baseline, week 6, week 12, week 16)
研究者
Nur Aini
MSc
Taipei Medical University
