An interventional study of Novel CogXergaming Training and Exercise and Education Training Program in MCI and Aging, sponsored by University of Illinois at Chicago. Not yet recruiting at 1 site in United States. Open to participants aged 55 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Treatment
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.
Alzheimer's disease/Alzheimer's disease and related dementias (AD/ADRD) significantly impair cognitive function and the ability to perform activities of daily living in older adults. Mild Cognitive Impairment (MCI) is a transitional phase between age-associated cognitive decline and dementia, which affects about 17% of older adults and can impair multiple domains of cognitive functioning (executive function, memory, etc.). Further, there is a well-established relationship between cognitive decline and reduced mobility, and OAwMCI show gait and balance deficits compared to cognitively intact older adults (CIOA), resulting in a 2-fold increase in the risk of falling. Fall-related consequences (e.g., injury) can significantly increase sedentary behavior and reduce physical activity, thus leading to a vicious cycle of deconditioning and reduced mobility, which significantly increases the risk of experiencing another fall. Further, sedentary behavior and deconditioning can accelerate the rate of conversion from MCI to AD/ADRD.
Exercise interventions are a promising approach to not only improve motor function, balance, and mobility in OAwMCI but also to improve cognitive function via several mechanisms of action. However, few exercise interventions for OAwMCI explicitly target cognitive processing in challenging conditions, such as dual tasking (i.e., simultaneous motor+cognitive task). Exergaming is a form of dual-task training that could reduce CMI in OAwMCI by providing combined cognitive stimulation and motor training in challenging environments that activate multiple cognitive processes, using digital gaming platforms. However, most existing exergames have focused only on the physical domain (promoting physical activity or exercise), and there is limited evidence on whether exergaming yields more cognitive benefit than conventional training. To explicitly target cognitive function and dual tasking ability, the investigators have developed a novel paradigm that integrates advanced computer vision technology and a cloud-based platform to provide more scalable, engaging, and customizable cognitive-motor training for OAwMCI. This CXT paradigm overcomes barriers of commercial exergaming systems (Wii Fit, Kinect) and requires minimal technology (webcam, computer/tablet), thus being more scalable and cost-effective.
The current proposal will examine the effects of 8 weeks of CXT on dual tasking ability, balance, and mobility, and patient-centered outcomes in OAwMCI, compared to an exercise and education program (EEP).
Aim 1: Examine the immediate effects of CXT on mechanistic measures of CMI in OAwMCI by comparing the dual task costs during both volitional and reactive balance tasks between groups after 8 weeks of training.
Aim 2: Examine the immediate effects of CXT on dynamic balance, mobility, and endurance in OAwMCI, and the investigators will also compare the cognitive function using the NIH cognitive toolbox between groups immediately after the training (Ancillary Aim).
Aim 3: Examine the immediate and sustained effects of CXT on patient-centered measures of physical activity, falls efficacy, and quality of life, and examine whether reductions in CMI (Aim 1) and improved balance, mobility, and endurance (Aim 2) will mediate improvements in patient-centered outcomes.
Exploratory analysis: To understand stakeholder (participants, clinicians) perceptions regarding CXT and facilitators/barriers for translation of the intervention into home and community settings, focus groups will be conducted to assess system usability, acceptability, attitudes, and intrinsic motivation via self-reported questionnaires and recorded transcripts.
University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
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Exclusion Criteria:
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
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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)
Dual-task Stance Perturbation Test (SPT)
Measures changes in the center of pressure (COP) displacement under dual-task conditions during SPT compared to single-task conditions.
Time frame: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)
Timed up and go (TUG)
Measures functional mobility by assessing the time taken to stand up, walk, and return to a seated position.
Time frame: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)
6 Minute Walk Test (6MWT)
Assesses aerobic endurance and walking ability by measuring the distance walked in 6 minutes.
Time frame: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)
NIH motor toolbox- standing balance test
Assesses balance control during standing.
Time frame: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)
NIH motor toolbox- 4-meter walking test.
A walking speed test that assesses for functional limitations and physical performance
Time frame: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)
36-Item Short Form Survey (SF-36)
Evaluates health-related quality of life, including physical and mental health components. The score ranges from 0 to 100, and higher score indicate better quality of life.
Time frame: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)
Weekly # of steps
Tracks physical activity levels by recording the number of steps per week using pedometer
Time frame: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)
The NIH Toolbox Fluid Cognition Composite Score
The Fluid Cognition Composite Score from the NIH Toolbox Cognitive Battery assesses executive function, attention, episodic memory, working memory, and processing speed, with a mean score of 100 and a standard deviation of 15. Higher scores indicate better cognitive function.
Time frame: Baseline (session 1) and immediate post-training (session 20), and 2-month post-training (session 21)
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University of Illinois at Chicago