Cognitive-motor Training in Community-dwelling Older People With Mild Cognitive Impairment
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Mahidol University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Stroop stepping test
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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.
Outcomes
Primary Outcomes
Stroop stepping test
Time Frame: Baseline, 3-month reassessment, 6-month post-intervention , and 12-month post-intervention
Stroop stepping test (SST) will be used to measure the ability to perform accurate stepping with response inhibition using the Choice Stepping Reaction Time Test. This equipment consists of a custom-made dance pad (150×90cm) which is connected to a computer and display screen (1280 × 768 pixels; 60 Hz; 58 cm). The test will start when an arrow shows in the centre of the monitor pointing in one of four directions (up, down, left and right) that matched the four possible step directions (forward, backward, left and right). A word indicating a different direction will be written inside the arrow. Participants will be instructed to 'Step by the word' and will have to inhibit the response indicated by the arrow's orientation. Four practice trials are not included in the score and 20 trials will be administered randomly by the directions of word and orientation. The average time (ms) and number of errors will be recorded.
Physiological profile assessment
Time Frame: Baseline, 3-month reassessment, 6-month post-intervention , and 12-month post-intervention
Fall risk will be assessed with the Physiological Profile Assessment (PPA), which provides a total fall-risk score from five measures: edge contrast sensitivity, lower limb proprioception, lower limb strength, simple hand reaction time, and postural sway. Edge contrast will be tested with the Melbourne Edge Test, proprioception by toe alignment with eyes closed, strength by maximal leg extension against a spring gauge, reaction time by response to a light stimulus via modified mouse, and sway by swaymeter during 30-second standing trials on firm and foam surfaces with eyes open and closed. PPA assessments will be used to calculate the PPA fall-risk score, with higher scores indicating poorer physical performance and greater risk of falling.
Secondary Outcomes
- Event Related Potential (ERP)(Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention)
- Timed Up and Go Test(Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention)
- Short Physical Performance Battery(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)(Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention)
- Semantic fluency(Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention)
- The modified switching verbal fluency test(Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention)
- The digit symbol substitution(Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention)
- The Digit Span test(Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention)
- Short Falls Efficacy Scale international(Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention)
- 30s-Chair-Stand Test(Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention)
- Thai Geriatric Depression Scale(Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention)
- Falls rate (12 month prospective falling record)(3-month reassessment, 6-month post-intervention, and 12-month post-intervention)
- System Usability Scale (intervention group only)(Baseline and 3-month reassessment)
- Thai Geriatric Anxiety Scale(Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention)
- Electroencephalogram (EEG)(Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention)
- Physical Activity Scale for Elderly Thai version(Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention)
- WHOQOL-BREF-THAI(Baseline, 3-month reassessment, 6-month post-intervention, and 12-month post-intervention)
- Physical Activity Enjoyment Scale (PACES) Thai version(Baseline and 3-month reassessment)
- Sessions and time recorded by training system and logbook record(Baseline and 3-month reassessment)