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

Mahidol University

Status: Not yet enrolling

Conditions: Mild Cognitive Impairment (MCI)

Treatments: Device: Smart±step cognitive-motor training

Study type: Interventional

Funder types: Other

Identifiers

NCT07241598

MU-CIRB 2025/147.0205

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

The intervention group will receive Smart±step cognitive-motor training for 12 weeks

Experimental group

Description:

Participants allocated to the intervention group will be provided with the Smart±step system and recommended to exercise at least 120 minutes per week for 12 weeks.

Treatment:

Device: Smart±step cognitive-motor training

The control group

No Intervention group

Description:

The control group will receive usual care and existing healthy living information.