Exergames for Mild Cognitive Impairment

Overseen By Dereck Salisbury

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Dementia, MCI, Neurological disorder, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether home-based exercise games and aerobic exercise can help with memory and thinking issues that often signal early Alzheimer's disease. Researchers will divide participants into two groups: one using exercise games and the other doing aerobic exercises, both at home. The research aims to determine if these activities, specifically concurrent aerobic exercise and cognitive training, can improve cognitive functioning and potentially delay Alzheimer's progression. It suits English-speaking adults aged 65 and older who have noticed a decline in memory or thinking over the past two years and are not currently in another study. As an unphased trial, this study offers a unique opportunity to contribute to early-stage research that could lead to innovative approaches for managing Alzheimer's symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these exergames are safe for older adults?

Research shows that aerobic exercise and mental training are generally safe for older adults. One study found that combining both is well-tolerated, with participants usually experiencing no serious side effects. Aerobic exercise is known to enhance brain health and improve thinking skills. Another study found that both aerobic exercise and mental training can positively affect cognitive function and brain health.

This study focuses on combining these exercises, which have been safely used in similar research. Prospective participants can feel reassured knowing these activities are safe for most people and have been used in other studies without major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for mild cognitive impairment because they combine aerobic exercise with cognitive training in a novel way. Unlike standard treatments that might focus on medications or traditional cognitive exercises alone, these "exergames" integrate physical activity and mental challenges simultaneously, potentially enhancing brain health and cognitive function more effectively. This dual approach addresses both physical and cognitive aspects of the condition, offering a holistic and engaging strategy that could lead to improved outcomes for patients.

What evidence suggests that this trial's treatments could be effective for mild cognitive impairment?

Research shows that combining aerobic exercise with brain training can boost mental abilities in older adults. Studies have found that this combination, sometimes called "exergaming," can improve memory and thinking skills. In this trial, participants will be randomized into groups to receive either HbExergame or HbAEX. One study discovered that people who engaged in both activities had better attention and memory than those who did not. This method might help delay Alzheimer's disease by keeping the brain active and healthy. Early results suggest these exercises could be a promising way to support brain health in people with mild memory issues. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 65 and older who feel their memory or cognitive abilities have declined in the past two years, can speak English, and score above 26 on a cognitive assessment (MoCA). They must be able to exercise without health risks as per ACSM guidelines.

Inclusion Criteria

I speak English.

I have no health issues preventing me from exercising.

My cognitive function is good, with a MoCA score above 26.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either home-based Exergame or aerobic exercise for 3 months

12 weeks

Asynchronous telerehabilitation sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Concurrent Aerobic Exercise and Cognitive Training

Trial Overview The study compares two home-based interventions over three months: Exergame (video games that are also a form of exercise) and aerobic exercise. Both are delivered through telerehabilitation. The goal is to see which method might prevent Alzheimer's by improving cognition and physical fitness.

How Is the Trial Designed?

Group I: Group 2 Experimental Treatment 2 Interventions

Subjects randomized to HbExergame

Group II: Group 1 Experimental Treatment 1 Intervention

Subjects randomized to HbAEX

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

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]

The 'Brain-IT' training concept, which combines exergame-based motor-cognitive training with heart rate variability guided breathing, was found to be feasible and well-accepted by older adults with mild neurocognitive disorder (mNCD) in a pilot study involving 18 participants over 12 weeks.

Participants reported high enjoyment and motivation levels while using the exergame, although technical issues with the system were noted as barriers, indicating a need for improvements in the technology to enhance the training experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, usability, and acceptance of "Brain-IT"-A newly developed exergame-based training concept for the secondary prevention of mild neurocognitive disorder: a pilot randomized controlled trial. Manser, P., Poikonen, H., de Bruin, ED.[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]

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 systematic review of 17 randomized controlled trials involving 926 participants found that exergames significantly improve overall cognitive functioning, with a moderate effect size (g=0.436).

Exergames were effective in enhancing specific cognitive domains such as executive functions, attention, and visuospatial skills, benefiting both healthy older adults and clinical populations with neurocognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of active video games on cognitive functioning in clinical and non-clinical populations: A meta-analysis of randomized controlled trials. Stanmore, E., Stubbs, B., Vancampfort, D., et al.[2022]

The tele-Exergame system, designed for older adults with mild cognitive impairment or dementia, was found to be acceptable and feasible, with participants engaging in the program twice weekly for six weeks.

Participants reported positive attitudes and perceived benefits from the tele-Exergame, suggesting it may help preserve cognitive function and improve balance in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-Medicine Based and Self-Administered Interactive Exercise Program (Tele-Exergame) to Improve Cognition in Older Adults with Mild Cognitive Impairment or Dementia: A Feasibility, Acceptability, and Proof-of-Concept Study. Park, C., Mishra, RK., York, MK., et al.[2023]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06340659

Concurrent Aerobic Exercise and Cognitive Training to ... Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergames Telerehabilitation Study). ClinicalTrials ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11138364/

The Effects of Exergame Telerehabilitation in Persons With ... Efficacy of simultaneous aerobic exercise and cognitive training in subjective cognitive decline: Study protocol for randomized controlled trial of the ...

3. trialx.com trialx.com/clinical-trials/listings/304450/concurrent-aerobic-exercise-and-cognitive-training-to-prevent-alzheimers-in-at-risk-older-adults-the-exergames-telerehabilitation-study/

Concurrent Aerobic Exercise and Cognitive Training to ... Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (The Exergames Telerehabilitation Study).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04311736

Concurrent Aerobic Exercise and Cognitive Training to ... The purpose of this project is to demonstrate the feasibility and efficacy of the Exergame intervention on cognition. An RCT is planned in which subjects are ...

5. spandidos-publications.com spandidos-publications.com/10.3892/wasj.2025.327

Effect of combined aerobic exercise and cognitive training ... The present study demonstrates that the combination of aerobic and cognitive exercise is beneficial leading to improvements in the cognitive function.

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2807450

Effects of Exercise Alone or Combined With Cognitive ... This randomized clinical trial examines the effectiveness of aerobic-resistance exercise with and without computerized cognitive training ...