Dementia Clinical Trial
— DTTOfficial title:
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
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: 1. . Does dual-task training affect primary outcomes (global cognitive function, executive function, and working memory) 2. . 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.
Status | Not yet recruiting |
Enrollment | 72 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Nursing Home | Malang | Jawa Timur |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University |
Indonesia,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global cognitive function | 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). | baseline, week 6, week 12, week 16 | |
Primary | Executive function | 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 | baseline, week 6, week 12, week 16 | |
Primary | Working memory | 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 | baseline, week 6, week 12, week 16 | |
Secondary | Sleep Quality | Sleep Quality is measured using two instruments. First: Pittsburgh Sleep Quality Index (PSQI). This instrument consists of a 19-item self-rated questionnaire to assess sleep quality during the last month, which includes seven domains, i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The score for each domain ranges from 0 to 3, and the total PSQI score ranges from 0 to 21. PSQI score of > 5 indicate poor sleep quality.
Second: Insomnia Severity Index (ISI). The insomnia severity index is a 7-item self-report questionnaire assessing insomnia's nature, severity, and impact in the past two weeks. The total score is interpreted as follows: absence of insomnia (0-7), sub-threshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28) |
baseline, week 6, week 12, week 16 | |
Secondary | Behavioral disturbance | Behavioral disturbance, also known as behavioral and psychological symptoms of dementia (BPSD) or neuropsychiatric symptoms. Behavioral disturbances can be grouped into four categories: mood disorders (such as depression, anxiety, apathy, and euphoria); sleep disorders (such as insomnia, hypersomnia, and night-day reversal); psychotic symptoms (such as hallucinations and delusions); and agitation (such as pacing, wandering, sexual disinhibition, and aggression). Behavioral disturbance will be assessed using the Neuropsychiatric Inventory-Questionnaire (NPI-Q). A higher score pointed to higher severity of neuropsychiatric symptoms (NPS). | baseline, week 6, week 12, week 16 | |
Secondary | Balance | measured using the Short Form Berg Balance Scale (SFBBS). Total score varies from 0 to 14. Higher scores indicate better balance and lower risk of falling | baseline, week 6, week 12, week 16 | |
Secondary | Flexibility | Flexibility is measured through two ways. The first test is the Chair sit-and-reach test (CSR). CSR is used to measure hamstring flexibility. Participants were instructed to reach down the extended leg in an attempt to touch the toes. The middle of the toe at the end of the shoe represented a "zero" score. Reaches short of the toes were recorded as minus scores, and reaches beyond the toes were recorded as plus scores.
The second test is Back scratch test, used to measure upper body and shoulder flexibility. The participants started the test by standing upright, placing one arm/hand on the lower back, and moving it up the spine toward their head. The gap between the fingertips of the long fingers of both hands was measured to the nearest half cm. The results were recorded in the nearest half cm, as back scratch right arm and left arm over, with positive numbers as long as the fingers overlapped and with negative numbers if the fingers did not meet. |
baseline, week 6, week 12, week 16 |
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