Tele-Exergaming for Mild Cognitive Impairment

Overseen By Alexis Noirot, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Severe cognitive impairment, Immobility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new remote exercise program for adults with mild cognitive issues or dementia. The goal is to improve balance and cognitive function through game-based exercises that participants can perform at home, supervised via telemedicine. One group will use a tele-exergaming platform (Remote Game-based Exercise Program), while the other will perform similar exercises without technology. Suitable candidates for this trial have dementia or cognitive impairment, live independently with a caregiver, and can walk at least 30 feet. As an unphased trial, participants can contribute to innovative research that may enhance daily living for those with cognitive challenges.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this remote game-based exercise program is safe for individuals with mild cognitive impairment?

Studies have shown that exercise can help maintain brain health in older adults. Researchers are testing a remote, game-based exercise program to determine its effectiveness for individuals with mild memory problems or dementia. Research on similar programs has shown they are usually safe and well-tolerated. No serious side effects were reported in these studies, suggesting this program is likely safe for participants.

The trial is labeled "Not Applicable" for its phase, indicating that researchers are focusing on improving the program rather than testing a new drug. This suggests the program is expected to be safe. Any issues can be quickly addressed because the program is supervised remotely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how technology can make a difference in managing mild cognitive impairment. Unlike traditional exercise routines, which might involve in-person sessions or home workouts without guidance, this trial uses tele-exergaming—a remote, game-based exercise platform. This approach could make staying active more engaging and accessible, especially for those who might struggle with motivation or mobility. The trial aims to find out if adding a digital, interactive element to exercise can improve cognitive health outcomes more effectively than standard exercise routines.

What evidence suggests that this remote game-based exercise program is effective for mild cognitive impairment?

Research shows that remote exercise programs using tele-exergames can help older adults with mild memory or thinking problems improve their balance and brain function. Eleven studies have found that these interactive games enhance balance, walking, decision-making, and memory. In simpler terms, playing these games helps people think more clearly and move better. Specifically, exergaming improves physical flexibility, joint movement, and coordination. These benefits are important for reducing the risk of falls and helping people live independently. In this trial, participants will either engage in remote exercise with tele-exergaming or perform home-based exercises without technology. Overall, evidence suggests that tele-exergaming is a promising way to keep both the mind and body healthy. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults who can walk at least 30 feet, with or without help, and have been diagnosed with dementia or mild cognitive impairment. They should live independently but have a caregiver available. It's not suitable for those with severe cognitive issues (MoCA score <16), major mobility disorders, or significant hearing/vision impairments.

Inclusion Criteria

I can walk at least 30 feet by myself or with help.

I live at home and have someone who helps take care of me.

I have been diagnosed with dementia or cognitive impairment.

Exclusion Criteria

You have severe problems with memory and thinking.

I have significant hearing or vision loss.

I cannot move well enough to safely do weight-bearing exercises.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of cognitive and motor function using wearable sensors and questionnaires

1 week

1 visit (in-person)

Treatment

Participants engage in a 12-week home exercise program, with the intervention group using the Tele-exergame platform

12 weeks

Remote supervision

Follow-up

Participants are monitored for changes in cognitive and motor function, fear of falling, and adherence

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote Game-based Exercise Program

Trial Overview

The study tests a remote exercise program using a Tele-Exergame Platform to improve balance and cognition in older adults with memory problems. Participants will use this system at home while being monitored remotely, as opposed to not using the platform.

How Is the Trial Designed?

Group I: Remote Exercise with tele-exergame Active Control 1 Intervention

Subjects will perform exercises remotely twice a week with tele-exergaming platform.

Group II: home-based exercise without technology Placebo Group 1 Intervention

Subjects will perform exercises at home without tele-exergaming platform twice a week.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

BioSensics

Industry Sponsor

Trials

17

Recruited

1,200+

BioSensics LLC

Collaborator

Trials

5

Recruited

420+

Published Research Related to This Trial

A pilot study involving 14 older adults tested a portable neuro-exergame (iPACES™ v2.0) over three months, showing significant improvement in executive function, particularly in the Stroop test (d = 0.68, p = 0.02).

Changes in salivary biomarkers like cortisol and IGF-1 were linked to cognitive improvements, suggesting potential neurobiological mechanisms behind the benefits of the neuro-exergame in combating cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Enhanced Interactive Physical and Cognitive Exercise System (iPACESTM v2.0): Pilot Clinical Trial of an In-Home iPad-Based Neuro-Exergame for Mild Cognitive Impairment (MCI). Wall, K., Stark, J., Schillaci, A., et al.[2023]

A 12-week multimodal physical exercise program significantly improved mobility and executive function in elderly individuals with mild cognitive impairment (MCI), but did not show similar benefits for those with Alzheimer's disease (AD).

The study involved 56 participants (28 in the exercise group and 28 in the control group), and the results suggest that physical exercise can be a beneficial intervention for those in the early stages of neurocognitive disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three months of multimodal training contributes to mobility and executive function in elderly individuals with mild cognitive impairment, but not in those with Alzheimer's disease: A randomized controlled trial. de Oliveira Silva, F., Ferreira, JV., Plácido, J., et al.[2019]

A 12-month structured exercise program did not lead to significant improvements in cognitive performance for individuals with mild cognitive impairment (MCI) compared to a non-exercise control group, based on a study of 183 participants.

However, the exercise intervention did result in improved physical fitness, as indicated by higher VO2 peak levels in the exercise groups, suggesting that while cognitive benefits were not observed, enhanced physical fitness may play a role in long-term disease progression and should be explored further.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NeuroExercise: The Effect of a 12-Month Exercise Intervention on Cognition in Mild Cognitive Impairment-A Multicenter Randomized Controlled Trial. Stuckenschneider, T., Sanders, ML., Devenney, KE., et al.[2021]

A 6-month randomized clinical trial involving 14 older adults with mild cognitive impairment (MCI) found that both interactive exercise conditions (exer-tour and exer-score) led to significant improvements in executive function and verbal memory, indicating cognitive benefits from physical activity combined with mental challenges.

The study also observed biological changes, such as increased BDNF levels and gray matter volume in brain regions associated with cognitive function, suggesting that both types of exercise may promote brain health in older adults at risk for cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Aerobic and Cognitive Exercise Study (ACES) for Community-Dwelling Older Adults With or At-Risk for Mild Cognitive Impairment (MCI): Neuropsychological, Neurobiological and Neuroimaging Outcomes of a Randomized Clinical Trial. Anderson-Hanley, C., Barcelos, NM., Zimmerman, EA., et al.[2022]

Virtual-reality-based cognitive training (VRCT) significantly improved cognitive function in older adults with mild cognitive impairment (MCI), as evidenced by better scores on the Mini-Mental State Examination (MMSE) after 24 sessions of training.

Both VRCT and exercise interventions enhanced cognitive and physical health, with exercise also improving handgrip strength, indicating that both methods are beneficial for older adults with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality and Exercise Training Enhance Brain, Cognitive, and Physical Health in Older Adults with Mild Cognitive Impairment. Yang, JG., Thapa, N., Park, HJ., et al.[2023]

The VITAAL exergame prototype was found to be enjoyable and beneficial for older adults with major neurocognitive disorder (MNCD), showing higher post-intervention scores on the Mini-Mental State Examination (MMSE) compared to traditional exercise after a 12-week program.

Participants in the exergame group experienced cognitive benefits, suggesting that this engaging form of exercise may help maintain cognitive function in individuals with MNCD, especially when guided by health professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of a stepping exergame prototype for older adults with major neurocognitive disorder residing in a long-term care facility: a mixed methods pilot study. Swinnen, N., de Bruin, ED., Guimarães, V., et al.[2023]

Home-based virtual reality (VR) exercise is safe and feasible for individuals with mild cognitive impairment, with participants completing 99% of the prescribed sessions over 6 weeks without major adverse events.

While most participants enjoyed the VR program and reported physical benefits, no significant changes were observed in physical or cognitive outcomes after the 6-week intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Home-Based Nonimmersive Virtual Reality to Encourage Physical and Cognitive Exercise in People With Mild Cognitive Impairment: A Feasibility Study. Sheehy, L., Sveistrup, H., Knoefel, F., et al.[2022]

A study involving 20 older adults showed that a 20-minute session of interactive physical and cognitive exercise using a neuro-exergame significantly improved executive function in participants with mild cognitive impairment (MCI) compared to normative older adults.

Participants with MCI also exhibited greater changes in alpha-amylase levels, suggesting that this type of exercise may have beneficial effects on both cognitive performance and biological markers related to stress or cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain Health Indicators Following Acute Neuro-Exergaming: Biomarker and Cognition in Mild Cognitive Impairment (MCI) after Pedal-n-Play (iPACES). Nath, K., Ferguson, I., Puleio, A., et al.[2023]

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