Dual-Task Training for People With Mild Cognitive Impairment and Mild Dementia
NCT ID: NCT06348810
Last Updated: 2024-05-29
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
72 participants
INTERVENTIONAL
2024-07-01
2024-12-30
Brief Summary
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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.
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Detailed Description
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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.
Outcomes: The primary outcomes of this study are global cognitive function, executive function, and working memory. Global cognitive is measured using MMSE that consists of five domains. MMSE 0-17 scores indicating severe cognitive impairment, 18-23 mild cognitive impairment, and 24-30 as normal (no cognitive impairment). MMSE was valid and had reliability of 0.763. Executive function in this study will measure using the Wisconsin card sort test (WCST), which has satisfactory reliability and validity for measuring executive function, possessing a split-half reliability of 0.89-0.93 for older adults and test-retest reliability of 0.76. Working memory is measured using a Digit span (DS) test that comprises both digit forward (16 points) and digit backward (14 points). The secondary outcomes of this study are sleep quality, behavioral disturbance, balance, and flexibility. Sleep quality is measured using the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI). Behavioral disturbance will be assessed with the Neuropsychiatric Inventory-Questionnaire (NPI-Q). Balance is measured with the Short Form Berg Balance Scale (SFBBS), and flexibilty using flexibility using the Chair sit-and-reach test (CSR) and Back scratch test.
Post-test and Follow-up Data Collection Procedure Participants will be requested to complete questionnares consist of: MMSE, WCST, DS, PSQI, ISI, NPI-Q, SFBBS, Chair sit-and-reach test (CSR) and Back scratch test, in the middle session of the intervention (week 6, after session 18), after intervention completed (week 12, 1 month follow-up time (week 16, measured from baseline)
Statistical analysis: The collected data will be analyzed using IBM SPSS for Windows version 23 and assumed a statistical significance level of p ≤ 0.05. Data consistency checks will be conducted to verify the reliability of the data collected. Descriptive statistics (frequency, percentage, mean, and standard deviation) will be used to summarize the characteristics of the participants and the outcomes. To compare the baseline group differences, investigators will use Chi-square or Fisher exact tests for categorical data, and independent t-tests for continuous data with normal distribution. The generalized estimating equation (GEE) test is used for analyze main outcome with follow the intention-to-treat (ITT) analysis principle, and this test can handle missing data, so no need imputation for missing data.
Interim Analysis and Stopping Guideline: During the study and subsequent follow-up data collection, investigators do not expect any issues that would be harmful to the participants. Investigators have no established termination criteria, and investigators do not plan to perform interim analyses before the follow-up data collection is completed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Dual-task training
The dual-task training is a combination of cognitive tasks and motor tasks which is done simultaneously or at the same time.
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.
Cognitive training
Participants only receive cognitive tasks
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.
Motor training
Participants only receive motor tasks
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.
Usual care
assist participants with activities of daily living, medication management, and social activities (such as singing, watching television).
Interventions
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Dual-task training
The dual-task training is a combination of cognitive tasks and motor tasks which is done simultaneously or at the same time.
Cognitive training
Participants only receive cognitive tasks
Motor training
Participants only receive motor tasks
Usual care
assist participants with activities of daily living, medication management, and social activities (such as singing, watching television).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CDR score range from 1 to 4
* MMSE score \>= 18
* Complain of conscious cognitive decline.
* Participate voluntarily and sign informed consent.
Exclusion Criteria
* 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.
60 Years
ALL
Yes
Sponsors
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Taipei Medical University
OTHER
Responsible Party
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Nur Aini
MSc
Principal Investigators
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Nur Aini, MSc
Role: PRINCIPAL_INVESTIGATOR
School of Nursing, College of Nursing, Taipei Medical University
Locations
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Nursing Home
Malang, East Java, Indonesia
Countries
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Central Contacts
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Facility Contacts
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References
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Bayot M, Dujardin K, Tard C, Defebvre L, Bonnet CT, Allart E, Delval A. The interaction between cognition and motor control: A theoretical framework for dual-task interference effects on posture, gait initiation, gait and turning. Neurophysiol Clin. 2018 Dec;48(6):361-375. doi: 10.1016/j.neucli.2018.10.003. Epub 2018 Oct 26.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Chiu HL, Chan PT, Kao CC, Chu H, Chang PC, Hsiao SS, Liu D, Chang WC, Chou KR. Effectiveness of executive function training on mental set shifting, working memory and inhibition in healthy older adults: A double-blind randomized controlled trials. J Adv Nurs. 2018 May;74(5):1099-1113. doi: 10.1111/jan.13519. Epub 2018 Jan 24.
Baltaci G, Un N, Tunay V, Besler A, Gerceker S. Comparison of three different sit and reach tests for measurement of hamstring flexibility in female university students. Br J Sports Med. 2003 Feb;37(1):59-61. doi: 10.1136/bjsm.37.1.59.
Abbas-Zadeh M, Hossein-Zadeh GA, Vaziri-Pashkam M. Dual-Task Interference in a Simulated Driving Environment: Serial or Parallel Processing? Front Psychol. 2021 Jan 12;11:579876. doi: 10.3389/fpsyg.2020.579876. eCollection 2020.
Ambrogio F, Martella LA, Odetti P, Monacelli F. Behavioral Disturbances in Dementia and Beyond: Time for a New Conceptual Frame? Int J Mol Sci. 2019 Jul 25;20(15):3647. doi: 10.3390/ijms20153647.
Kuan YC, Huang LK, Wang YH, Hu CJ, Tseng IJ, Chen HC, Lin LF. Balance and gait performance in older adults with early-stage cognitive impairment. Eur J Phys Rehabil Med. 2021 Aug;57(4):560-567. doi: 10.23736/S1973-9087.20.06550-8. Epub 2020 Dec 1.
Tzeng RC, Yang YW, Hsu KC, Chang HT, Chiu PY. Sum of boxes of the clinical dementia rating scale highly predicts conversion or reversion in predementia stages. Front Aging Neurosci. 2022 Sep 23;14:1021792. doi: 10.3389/fnagi.2022.1021792. eCollection 2022.
Yang HL, Chu H, Kao CC, Chiu HL, Tseng IJ, Tseng P, Chou KR. Development and effectiveness of virtual interactive working memory training for older people with mild cognitive impairment: a single-blind randomised controlled trial. Age Ageing. 2019 Jul 1;48(4):519-525. doi: 10.1093/ageing/afz029.
Musa G, Henriquez F, Munoz-Neira C, Delgado C, Lillo P, Slachevsky A. Utility of the Neuropsychiatric Inventory Questionnaire (NPI-Q) in the assessment of a sample of patients with Alzheimer's disease in Chile. Dement Neuropsychol. 2017 Apr-Jun;11(2):129-136. doi: 10.1590/1980-57642016dn11-020005.
Other Identifiers
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DTT2024
Identifier Type: -
Identifier Source: org_study_id
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