Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348810
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-03-22
Brief Title:
Dual-Task Training for People With Mild Cognitive Impairment and Mild Dementia
Sponsor:
Taipei Medical University
Organization:
Taipei Medical University
Study Overview
Official 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DTT
Brief Summary:
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
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
Detailed Description:
Sample size calculation Investigators use the GPower sample size calculator under an F test with an analysis of variance based on some criteria for instance effect size 02 small power 80 four times measurement four groups cognitive training motor training dual-task training and control group and α error probability of 005 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
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 0763 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 089-093 for older adults and test-retest reliability of 076 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 005 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
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 0763 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 089-093 for older adults and test-retest reliability of 076 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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None