Clinical trial NCT06572878: Evaluation of Cognitive and Physical Training on MCI Elders
Official title: Evaluation of the Effect of Cognitive and Physical Training on Mild Cognitive Impairment Elder's Physical and Cognition Domain: A Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Mild Cognitive Impairment
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 144
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Participants must be aged 60 years or older and able to communicate in Mandarin or Taiwanese.
2. Mild cognitive impairment, assessed using the Mini Mental State Examination (MMSE) with a score of 14≦MMSE≦25.
3. Self-reported complaints of cognitive decline.
4. In addition to the above criteria, participants must voluntarily agree to participate and sign an informed consent form.

Exclusion Criteria:

1. 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.
2. Participants who have undergone other cognitive or activity training within the past six months.
3. Individuals with sensory impairments, such as visual, auditory, or communication difficulties.
4. People with mobility impairments, such as those who use wheelchairs or mobility aids.

Primary outcomes:
measure: Mini-Mental State Examination
timeFrame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
measure: Wisconsin Card Sorting Test - Computer Version
timeFrame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
measure: Digit Span Test
timeFrame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
measure: Shor-form Berg balance scale
timeFrame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
measure: Back scratch test
timeFrame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
measure: Chair sit-and-reach test
timeFrame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
measure: Grip and pinch strength
timeFrame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
measure: Gait analysis
timeFrame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
measure: Insomnia Severity Index
timeFrame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
measure: Actigraphy sleep efficiency (%)
timeFrame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
measure: Actigraphy total sleep time (minutes)
timeFrame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
measure: Actigraphy wake duration (minutes)
timeFrame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
measure: Actigraphy sleep onset latency (minutes)
timeFrame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
measure: Actigraphy time in bed (minutes)
timeFrame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
measure: Actigraphy sleep fragmentation (%)
timeFrame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention
Other outcomes:
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