Evaluation of Cognitive and Physical Training on MCI Elders

Taipei Medical University

Status: Not yet enrolling

Conditions: Cognitive Impairment; Mild Cognitive Impairment

Treatments: Other: Physical training; Other: Combined cognitive and physical training; Other: Passive information activities; Other: Cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT06572878

N202404122

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 4 patient groups

Cognitive training

Experimental group

Description:

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

Treatment:

Other: Cognitive training

Physical training

Experimental group

Description:

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

Treatment:

Other: Physical training

Combined cognitive and physical training

Experimental group

Description:

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

Treatment:

Other: Combined cognitive and physical training

Passive information activities

Active Comparator group

Description:

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

Treatment:

Other: Passive information activities