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NCT07241598

Cognitive-motor Training in Community-dwelling Older People With Mild Cognitive Impairment

Sponsor: Mahidol University

View on ClinicalTrials.gov

Summary

As the global population ages, the prevalence of mild cognitive impairment (MCI) among older adults, which ranges from 5% to 40%, is expected to rise. MCI significantly increases the risk of developing Alzheimer's disease and is associated with a heightened risk of falls, with evidence suggesting that individuals with MCI have a fall risk five times greater than their cognitively intact peers. While cognitive and physical impairments in MCI are recognized, targeted interventions addressing both aspects are needed. This study aims to evaluate the effectiveness of the Smart±step exergaming program, an interactive system combining cognitive and motor training through computer-based stepping tasks, in reducing risk of falls, fall rate and improving physical, cognitive, psychological, neurophysiological, and quality of life outcomes in community-dwelling older adults with MCI. Previous research indicates that combined cognitive-motor interventions can improve balance and cognitive outcomes, but evidence on their efficacy in reducing falls is limited. The study will assess whether the Smart±step program, previously shown to be effective in cognitively healthy populations, can also significantly reduce risk of fall, fall rates and enhance overall function in older people with MCI. If successful, the program could offer substantial benefits by lowering fall-related costs and disabilities, with potential for global adaptation and implementation.

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12-01

Completion Date

2027-12-01

Last Updated

2025-11-21

Healthy Volunteers

Conditions

Mild Cognitive Impairment (MCI)

Interventions

DEVICE

Smart±step cognitive-motor training

12 weeks of Smart±step cognitive-motor training for older people with mild cognitive impairment (MCI)

Inclusion Criteria: * Older people with MCI will be identified based on the core criteria outlined by the diagnostic scheme of MCI by Petersen and the National Institute on Aging-Alzheimer's Association and as follows: Subjective cognitive complaints (SCCs) will be assessed using four commonly endorsed items from Slavin et al., with a total score ≥3 indicating SCCs. Objective cognitive impairment will be determined using the Thai version of the Montreal Cognitive Assessment (MoCA), with inclusion criteria defined as MoCA scores of 20-25 for individuals with ≤12 years of education and 21-25 for those with \>12 years. Functional ability will be evaluated using the Bayer Activities of Daily Living Scale (B-ADL), with scores \<3 indicating no impairment. Participants with MoCA scores \<20 (≤12 years education) or \<21 (\>12 years) will be excluded to rule out dementia. Individuals meeting all four criteria-subjective complaints, objective cognitive impairment, preserved functional abilities, and absence of dementia-will be classified as having MCI. * Aged 60 years or more. * Thai-speaking language and able to read or understand the Thai language * Able to walk 10m independently (without a walking aid) Exclusion Criteria: * Having had a stroke in the last 2 years. * Having a progressive neurodegenerative disorder e.g. Parkinson's disease, Multiple sclerosis, amyotrophic lateral sclerosis (ALS). * Individuals who are blind, deaf, or amputees, whether the condition is congenital or acquired. * A medical condition that would interfere with the safety and conduct of the training and testing protocol or interpretation of the results, such as: 1. Musculoskeletal conditions e.g. severe pain of lower extremities (pain score \> 4/10), recent TKR/THR (less than or equal to 12 months after operation) and recent fracture (12-months). 2. Cardiopulmonary conditions e.g. unstable angina, uncontrolled hypertension. 3. Metabolic conditions e.g. severe or poorly controlled diabetes. 4. Mental health conditions e.g. severe or poorly controlled depression or psychiatric condition.

Locations (1)

Faculty of Physical Therapy

Salaya, Changwat Nakhon Pathom, Thailand