Evaluation of Cognitive and Physical Training on MCI Elders
- Conditions
- Mild Cognitive ImpairmentCognitive Impairment
- Interventions
- Other: Cognitive trainingOther: Physical trainingOther: Passive information activitiesOther: Combined cognitive and physical training
- Registration Number
- NCT06572878
- Lead Sponsor
- Taipei Medical University
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 144
- Participants must be aged 60 years or older and able to communicate in Mandarin or Taiwanese.
- Mild cognitive impairment, assessed using the Mini Mental State Examination (MMSE) with a score of 14≦MMSE≦25.
- Self-reported complaints of cognitive decline.
- In addition to the above criteria, participants must voluntarily agree to participate and sign an informed consent form.
- Individuals with severe psychiatric disorders or behavioral problems, as assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q) with (a) severity score ≥ 6 and caregiver distress score ≥ 7.
- Participants who have undergone other cognitive or activity training within the past six months.
- Individuals with sensory impairments, such as visual, auditory, or communication difficulties.
- People with mobility impairments, such as those who use wheelchairs or mobility aids.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive training Cognitive training Each participant will receive cognitive training for 45 minutes per session, three sessions per week, for 12 weeks. Physical training Physical training Each participant will receive physical training for 45 minutes per session, three sessions per week, for 12 weeks. Passive information activities Passive information activities Each participant will engage in passive information activities for 45 minutes per session, three sessions per week, for 12 weeks. Combined cognitive and physical training Combined cognitive and physical training Each participant will receive combined cognitive and physical training for 45 minutes per session, three sessions per week, for 12 weeks.
- Primary Outcome Measures
Name Time Method Digit Span Test Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention A standardized instrument for assessing working memory.
Mini-Mental State Examination Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention 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.
Wisconsin Card Sorting Test - Computer Version Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention 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.
Shor-form Berg balance scale Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention 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.
Chair sit-and-reach test Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention A flexibility test.
Back scratch test Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention A flexibility test.
Gait analysis Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention A standardized instrument " PABLO®" for assessing gait performance.
Grip and pinch strength Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention A standardized instrument " PABLO®" for assessing strength.
- Secondary Outcome Measures
Name Time Method Actigraphy sleep efficiency (%) Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention 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.
Insomnia Severity Index Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention 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.
Actigraphy sleep onset latency (minutes) Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention 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.
Actigraphy sleep fragmentation (%) Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention 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.
Pittsburgh Sleep Quality Index Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention 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.
Actigraphy total sleep time (minutes) Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention 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.
Actigraphy wake duration (minutes) Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention 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.
Actigraphy time in bed (minutes) Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention 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.