An interventional study of Cognitive training and Physical training in Cognitive Impairment and Mild Cognitive Impairment, sponsored by Taipei Medical University. Not yet recruiting. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Treatment
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.
The World Health Organization has recognized cognitive impairment as a significant global health issue, encompassing a spectrum of conditions from mild cognitive impairment to various forms of dementia. These conditions are linked to heightened risks of disability and mortality. In the absence of suitable interventions, cognitive functions typically exhibit a gradual decline over time, driven by factors including aging, neurological disorders, traumatic brain injury, and substance abuse.
A thorough literature review indicates that cognitive and physical training can sustain cognitive or physical functions, contingent upon the specific training protocols implemented. Concurrent cognitive and physical training entails the simultaneous execution of multiple cognitive and motor activities, thereby maintaining dual functional control. This innovative training modality integrates motor and cognitive rehabilitation into a cohesive framework.
This clinical trial adopts a randomized controlled design, stratifying participants into four distinct groups: cognitive training, physical training, combined cognitive and physical training, and passive informational activities. The interventions will be administered with a frequency of three times per week over a 12-week period, incorporating task-specific training to enhance both motor and cognitive functions.
3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.
This study's planned enrollment of 144 is above the median of 64 across 2,855 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Taipei Medical University is the lead sponsor of 256 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Each participant will receive cognitive training for 45 minutes per session, three sessions per week, for 12 weeks.
Other: Cognitive training
Each participant will receive physical training for 45 minutes per session, three sessions per week, for 12 weeks.
Other: Physical training
Each participant will receive combined cognitive and physical training for 45 minutes per session, three sessions per week, for 12 weeks.
Other: Combined cognitive and physical training
Each participant will engage in passive information activities for 45 minutes per session, three sessions per week, for 12 weeks.
Other: Passive information activities
Cognitive training will follow a group format, with each group consisting of 4-16 participants. Each group will be in a private, independent room for their training sessions and will not interact with participants from other groups. The cognitive training task components will specifically focus on attention, learning and memory, executive function, perceptual-motor skills, and language.
Physical training will follow a group format, with each group consisting of 4-16 participants. Each group will be in a private, independent room for their training sessions and will not interact with participants from other groups. The physical training task components will specifically focus on strength, balance, agility, gait, low-volume aerobic, and flexibility.
Combined cognitive and physical training will follow a group format, with each group consisting of 4-16 participants. Each group will be in a private, independent room for their training sessions and will not interact with participants from other groups. The combined cognitive and physical training components will specifically focus on a single cognitive task and simultaneously handle a single physical task.
In passive informational activities, which include a variety of puzzles, audiobooks, and diverse reading materials such as newspapers or listening to news content.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Back scratch test
A flexibility test.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
No study locations are listed for this record.
Plan to share: No — The investigators do not plan to make individual participant data (IPD) available to other researchers.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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