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

NCT07241598 | Not Yet Recruiting DMC

• 1 other identifier: MU-CIRB 2025/147.0205
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

mild cognitive impairment; MCI; dementia; cognitive training; older adults; older people; community-dwelling; cognitive-motor training; RCTs; exergaming program; A randomised controlled trial; falls; falling; preventing falls; risk of falls

Outcome Measures

Primary Outcomes (2)

• Stroop stepping test

  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.

  Baseline, 3-month reassessment, 6-month post-intervention , and 12-month post-intervention

• Physiological profile assessment

  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.

  Baseline, 3-month reassessment, 6-month post-intervention , and 12-month post-intervention

Secondary Outcomes (19)

• 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

• 30s-Chair-Stand Test

  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

Study Arms (2)

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

EXPERIMENTAL

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.

Device: Smart±step cognitive-motor training

The control group

NO INTERVENTION

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

Interventions

Smart±step cognitive-motor training DEVICE

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

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead
• Neuroscience Research Australia: collaborator

Study Sites (1)

Faculty of Physical Therapy

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Thanwarat Chantanachai, PhD

CONTACT

+66815235692; thanwarat.cha@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This research will use a single-blind randomized controlled trial (RCT) to assess the effects of the Smart±step cognitive-motor training program compared to usual care. The study will recruit community-dwelling older adults with MCI, defined using Petersen's criteria and objective cognitive measures such as the Montreal Cognitive Assessment (MoCA). Participants will be randomly allocated to either the Smart±step intervention group or the control group, with the intervention group receiving 120 minutes of Smart±step training per week for 12 weeks.

Study Record Dates

• First Submitted: May 31, 2025
• First Posted: November 21, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

TH (1)