Cognitive-Motor Training for AD/ADRD Prevention

ConditionsMCIAging
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-90
SponsorUniversity of Illinois at Chicago

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Novel CogXergaming Training

    Behavioral

    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.

  • Exercise and Education Training Program

    Behavioral

    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.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Novel CogXergaming TrainingExperimental treatment 1 intervention
Group B: Exercise and Education Training ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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)
4

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

1

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)

Sponsors and contacts

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