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

NCT ID: NCT07241598

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-12-01

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Smart±step cognitive-motor training

Intervention Type: DEVICE

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

The control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Smart±step cognitive-motor training

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuroscience Research Australia

OTHER

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty of Physical Therapy

Salaya, Changwat Nakhon Pathom, Thailand

Countries

Thailand

Central Contacts

Thanwarat Chantanachai, PhD

Role: CONTACT

thanwarat.cha@mahidol.ac.th

+66815235692

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

MU-CIRB 2025/147.0205

Identifier Type: -

Identifier Source: org_study_id