Evaluation of Cognitive and Physical Training on MCI Elders

NCT06572878 | Not Yet Recruiting DMC

• 1 other identifier: N202404122
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cognitive Impairment; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (8)

• Pittsburgh Sleep Quality Index

  Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention

• Insomnia Severity Index

  Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention

• Actigraphy sleep efficiency (%)

  Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention

• Actigraphy total sleep time (minutes)

  Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention

• Actigraphy wake duration (minutes)

  Baseline, 12 weeks (post-intervention), 3 months, and 6 months after completing the intervention

Study Arms (4)

Cognitive training

EXPERIMENTAL

Each participant will receive cognitive training for 45 minutes per session, three sessions per week, for 12 weeks.

Other: Cognitive training

Physical training

EXPERIMENTAL

Each participant will receive physical training for 45 minutes per session, three sessions per week, for 12 weeks.

Other: Physical training

Combined cognitive and physical training

EXPERIMENTAL

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

Passive information activities

ACTIVE COMPARATOR

Each participant will engage in passive information activities for 45 minutes per session, three sessions per week, for 12 weeks.

Other: Passive information activities

Interventions

Cognitive training OTHER

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.

Cognitive training

Physical training OTHER

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.

Physical training

Combined cognitive and physical training OTHER

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.

Combined cognitive and physical training

Passive information activities OTHER

In passive informational activities, which include a variety of puzzles, audiobooks, and diverse reading materials such as newspapers or listening to news content.

Passive information activities

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training; Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jia-You Ye, MSN

CONTACT

+886-9-03254198; tddey1224@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 27, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share