Evaluation of Cognitive and Physical Training on MCI Elders
NCT Number: NCT06572878
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognitive Impairment|Mild Cognitive Impairment
Interventions: OTHER: Cognitive training|OTHER: Physical training|OTHER: Combined cognitive and physical training|OTHER: Passive information activities
Sponsor: Taipei Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-02

Summary:
This study examines the impact of combining cognitive and physical training, recognizing that daily living often requires individuals to perform multiple tasks simultaneously. The inability to execute such dual movements can hinder daily functioning.

The primary goal is to enhance the ability of individuals with mild cognitive impairment (MCI) to perform two tasks concurrently, focusing on both cognitive and physical aspects. This research aims to deepen our understanding of how multitasking affects patients' abilities and to develop effective intervention programs.

Primary Outcome Measures: Mini-Mental State Examination, The Mini-Mental State Examination (MMSE) is a standardized instrument for assessing overall cognitive function, where higher scores indicate better global cognition, with a total score ranging from 0 to 30. It is crucial to consider both age and education levels when interpreting the results., Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention|Wisconsin Card Sorting Test - Computer Version, The Wisconsin Card Sorting Test (WCST) is a standardized instrument for assessing executive function. Interpreting WCST results includes analyzing the total correct responses and total errors. The total correct responses indicate the number of correct matches made by the participant; a higher number of correct responses suggests better overall cognitive performance and the ability to learn and apply the rules. Conversely, a high number of errors can indicate difficulties in understanding or applying the sorting rules., Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention|Digit Span Test, A standardized instrument for assessing working memory., Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention|Shor-form Berg balance scale, The Short-Form Berg Balance Scale (SFBBS) is a streamlined assessment tool designed to evaluate an individual's balance and stability. Each item on the SFBBS is scored on a scale from 0 to 4, with 0 indicating the lowest level of function and 4 indicating the highest level of function. The scores for each item are summed to obtain a total score, which provides an overall measure of balance. The maximum possible score varies depending on the number of items included in the short form., Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention|Back scratch test, A flexibility test., Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention|Chair sit-and-reach test, A flexibility test., Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention|Grip and pinch strength, A standardized instrument " PABLO®" for assessing strength., Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention|Gait analysis, A standardized instrument " PABLO®" for assessing gait performance., Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Secondary Outcome Measures: Pittsburgh Sleep Quality Index, The Pittsburgh Sleep Quality Index (PSQI) is a standardized instrument for assessing sleep quality and disturbances over a 1-month period. It evaluates seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction during the month preceding the test. The total score ranges from 0 to 21 points, with a total score greater than 5 indicating poor sleep., Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention|Insomnia Severity Index, The Insomnia Severity Index (ISI) is a validated tool for assessing the severity of insomnia symptoms and their impact on daily functioning. The scores for each item are summed to obtain a total score, which ranges from 0 to 28, with higher scores indicating worse sleep. A total score greater than 8 suggests the presence of insomnia., Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention|Actigraphy sleep efficiency (%), Sleep parameters were measured using wrist actigraphy (GT9X; Manufacturing Technology, Pensacola, FL, USA) to collect sleep data. Mean sleep efficiency was derived from actigraphy recordings as the ratio of total sleep time to time in bed, multiplied by 100. Restlessness, indicated by a sleep efficiency below 80%, should be carefully considered in elderly individuals., Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention|Actigraphy total sleep time (minutes), Sleep parameters are measured by the wrist actigraphy (GT9X; Manufacturing Technology, Pensacola, FL, USA) to collect sleep data. Mean total sleep time derived from actigraphy recordings., Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention|Actigraphy wake duration (minutes), Sleep parameters are measured by the wrist actigraphy (GT9X; Manufacturing Technology, Pensacola, FL, USA) to collect sleep data. Mean wake after sleep onset derived from actigraphy recordings., Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention|Actigraphy sleep onset latency (minutes), Sleep parameters are measured by the wrist actigraphy (GT9X; Manufacturing Technology, Pensacola, FL, USA) to collect sleep data. Mean sleep onset latency derived from actigraphy recordings. Restlessness, indicated if more than 30-60 minutes, should be carefully considered in elderly individuals., Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention|Actigraphy time in bed (minutes), Sleep parameters are measured by the wrist actigraphy (GT9X; Manufacturing Technology, Pensacola, FL, USA) to collect sleep data. Mean time in bed derived from actigraphy recordings., Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention|Actigraphy sleep fragmentation (%), Sleep parameters are measured by the wrist actigraphy (GT9X; Manufacturing Technology, Pensacola, FL, USA) to collect sleep data. Sleep fragmentation index (sum of limb movement and fragmentation indexes). The restlessness index during sleep, expressed as a percentage, indicates sleep disruption; higher values mean more disrupted sleep., Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention