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.

Overview

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.

Interventions

• Other Cognitive training
  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.
• Other Physical training
  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.
• Other Combined cognitive and physical training
  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.
• Other Passive information activities
  In passive informational activities, which include a variety of puzzles, audiobooks, and diverse reading materials such as newspapers or listening to news content.

Primary outcome measures

• Mini-Mental State Examination [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 [Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention]
• Digit Span Test [Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention]
• Shor-form Berg balance scale [Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention]
• Back scratch 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 [Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention]
• Grip and pinch strength [Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention]
• Gait analysis [Time frame: Baseline, 6 weeks (mid), 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention]

Secondary outcome measures (8)

• Pittsburgh Sleep Quality Index [Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention]
• Insomnia Severity Index [Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention]
• Actigraphy sleep efficiency (%) [Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention]
• Actigraphy total sleep time (minutes) [Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention]
• Actigraphy wake duration (minutes) [Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention]
• Actigraphy sleep onset latency (minutes) [Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention]
• Actigraphy time in bed (minutes) [Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention]
• Actigraphy sleep fragmentation (%) [Time frame: Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06572878 · N202404122

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗