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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Stroop stepping test [Срок оценки: Baseline, 3-month reassessment, 6-month post-intervention , and 12-month post-intervention]
• Physiological profile assessment [Срок оценки: Baseline, 3-month reassessment, 6-month post-intervention , and 12-month post-intervention]

Вторичные конечные точки (12)

• Timed Up and Go Test [Срок оценки: Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention]
• Short Physical Performance Battery [Срок оценки: Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention]
• 30s-Chair-Stand Test [Срок оценки: Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention]
• Trail-Making Test (TMT) Part A and B and the Controlled Oral Word Association Test (COWAT) [Срок оценки: Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention]
• Semantic fluency [Срок оценки: Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention]
• The modified switching verbal fluency test [Срок оценки: Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention]
• The digit symbol substitution [Срок оценки: Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention]
• The Digit Span test [Срок оценки: Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention]
• Short Falls Efficacy Scale international [Срок оценки: Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention]
• Thai Geriatric Depression Scale [Срок оценки: Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention]
• Thai Geriatric Anxiety Scale [Срок оценки: Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention]
• Electroencephalogram (EEG) [Срок оценки: Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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:

• 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).
• Cardiopulmonary conditions e.g. unstable angina, uncontrolled hypertension.
• Metabolic conditions e.g. severe or poorly controlled diabetes.
• Mental health conditions e.g. severe or poorly controlled depression or psychiatric condition.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Таиланд · 1 центр

• Faculty of Physical Therapy — Salaya

Идентификаторы

NCT: NCT07241598 · MU-CIRB 2025/147.0205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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