Evaluation of Cognitive and Physical Training on MCI Elders

NCT ID: NCT06572878

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2027-02-28

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.

Conditions

Cognitive Impairment; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive training

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

Group Type: EXPERIMENTAL

Cognitive training

Intervention Type: 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.

Physical training

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

Group Type: EXPERIMENTAL

Physical training

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Combined cognitive and physical training

Intervention Type: 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.

Passive information activities

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

Group Type: ACTIVE_COMPARATOR

Passive information activities

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jia-You, YE

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jia-You Ye, MSN

Role: CONTACT

tddey1224@icloud.com

+886-9-03254198

Other Identifiers

N202404122

Identifier Type: -

Identifier Source: org_study_id