NCT07160582

Brief Summary

Alzheimer's disease and related dementias (AD/ADRD) greatly affect memory and daily activities in older adults. Mild Cognitive Impairment (MCI) is an early stage of dementia, affecting about 17% of older adults. People with MCI often show problems with gait and balance, which doubles their risk of falling compared to cognitively healthy peers. Falls can cause injuries, increase sedentary behavior, and reduce physical activity. This decline in activity can also speed up the progression from MCI to dementia. Exercise can help older adults make healthy lifestyle changes; however, most of the existing exercise programs focus mainly on physical movement rather than cognitive function. Therefore, the investigators developed a new program that uses computer vision and a cloud-based system to provide more scalable, engaging, and personalized cognitive-motor training for OAwMCI. The purpose of this study is to investigate the short- and long-term effects of a novel CogXergaming training (CXT) paradigm for improving the cognitive-motor function, physical activity, falls efficacy, and quality of life.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Sep 2027

First Submitted

Initial submission to the registry

August 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

August 29, 2025

Last Update Submit

March 19, 2026

Conditions

Keywords

CogXergamingCognitive-motor interferenceDual-task

Outcome Measures

Primary Outcomes (4)

  • Dual-task Limits of Stability Test (LOS)

    Measures changes in max excursion under dual-task conditions during the LOS test compared to the single-task.

    Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  • Mini-BESTest

    Assesses 4 domains: anticipatory and reactive balance control (therapist-induced), sensory orientation, and gait. The value ranges from 0 to 28, and higher scores indicate better balance control.

    Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  • Physical Activity Scale of Elderly (PASE)

    Self-reported measure of physical activity levels in older adults. The score ranges from 0 to 799, higher scores indicate greater physical activity level.

    Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  • Activities Specific Balance Confidence (ABC)

    Assesses an individual's confidence in maintaining balance during various daily activities. The score ranges from 0 to 100, and higher scores indicate greater confidence in maintaining balance during activities

    Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

Secondary Outcomes (7)

  • Dual-task Stance Perturbation Test (SPT)

    Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  • Timed up and go (TUG)

    Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  • 6 Minute Walk Test (6MWT)

    Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  • NIH motor toolbox- standing balance test

    Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  • NIH motor toolbox- 4-meter walking test.

    Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

  • +2 more secondary outcomes

Other Outcomes (1)

  • The NIH Toolbox Fluid Cognition Composite Score

    Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)

Study Arms (2)

Novel CogXergaming Training

EXPERIMENTAL

Customized Novel CogXergaming Training based on cognitive-motor balance training will be delivered to Participants in group A. Participants will undergo 18 sessions of training for eight weeks, with around 60 minutes of training per session, i.e., 3 sessions per week in the first 2 weeks, and 2 sessions per week in the remaining 6 weeks. All the CXT training will be performed using a desktop with a webcam.

Behavioral: Novel CogXergaming Training

Exercise and Education Training Program

EXPERIMENTAL

Participants in Group B will complete 8 weeks of a conventional exercise program and fall-prevention education (3x/week in the first 2 weeks and 2x/week in the remaining 6 weeks, 18 sessions total) in the lab.

Behavioral: Exercise and Education Training Program

Interventions

In each session, participants will play 6 games in the same order (Fruit catch, Math, Tracking, Candy match, Letter Number Sequencing - LNS, Stroop), each of which contains 10-20 trials and will last for around 10 minutes (total = 60 minutes. The CXT program employs a progressive method to ensure the intensity of CXT remains challenging without overload. If a participant demonstrates ≥80% accuracy in 3 continuous trials for one game, then the exercises for this game will be progressed to the next level (levels: 1-9 in Table 3). Each session of CXT will last approximately 1 hour. At least one day of rest will be required between weekly training sessions.

Also known as: CXT
Novel CogXergaming Training

EEP consists of a conventional exercise program and fall-prevention education. The conventional exercise program comprises 50 minutes of supervised exercises for stretching and strengthening. A fall-prevention education program will also be provided to Group B, for about 10 minutes after each session of the exercise program. Each session of EEP will last approximately 1 hour. At least one day of rest will be required between weekly training sessions.

Also known as: EEP
Exercise and Education Training Program

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 55-90 years.
  • No recent major surgery, bone fracture, or hospitalization (\< 3 months).
  • Not on any sedative drugs.
  • Can understand and communicate in English.
  • Can walk without an assistive device for at least 1 block to ensure independent functioning.
  • Identification of Mild Cognitive Impairment (MCI) based on Jak/Bondi criteria
  • Visual acuity greater than or equal to 20/40 with or without corrective lenses to ensure intact vision.

You may not qualify if:

  • Participants will not proceed with the study if any of the following occurs at baseline measurement: 1) Heart Rate \>85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) \> 160 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting.
  • Unable to stand for 5 minutes without an assistive device and walk for 10 m without an assistive device
  • Complaints of shortness of breath, or uncontrolled pain (more than 3 out of 10 on Visual Analogue Scale), or if pulse oxygen drops less than 92% on the six-minute walk test (for endurance) to ensure that the participant can effectively participate without discomfort or injury during testing and training.
  • Exhibits difficulty understanding the study information.
  • Self-reported history or presence of any neurological, musculoskeletal, cardiorespiratory, or systemic disorders that significantly impact mobility or the ability to walk independently (without an assistive device).
  • Self-reported disability (with or without an assistive device) to ensure independent functioning.
  • Uncontrolled (not under any medications) hypertension to avoid cardiovascular complications during testing/training.
  • Weight \>220 lbs (harness weight threshold).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Shuaijie Wang, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuaijie Wang, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Controlled design to compare the effect of two different training programs on the cognitive-motor function, physical activity, falls efficacy, and quality of life in older adults with mild cognitive impairment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 8, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations