Exercise and Cognitive Training for Mild Cognitive Impairment

Overseen By Linda Chang, M.D., M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Heart disease, Hypertension, Diabetes, Substance use, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a combination of brain training and aerobic exercise can improve brain function in individuals with mild cognitive impairment (MCI) or those aging healthily. The study includes three groups: one engaging in both activities, one focusing on aerobic exercise, and one on cognitive training. Researchers aim to determine if these activities enhance memory and thinking skills. The trial seeks participants with MCI or those who feel less sharp than before and do not exercise regularly. Participants must also have access to a computer or iPad for the brain training component. As an unphased trial, this study offers a unique opportunity to contribute to understanding how lifestyle changes can enhance cognitive health.

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 might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this combination of exercise and cognitive training is safe for improving brain function?

Research has shown that combining aerobic exercise with brain training is generally safe and beneficial for brain health. Studies suggest this approach may enhance thinking skills and brain function in individuals with mild memory problems.

For aerobic exercise alone, evidence indicates it is usually well-tolerated and might help slow memory loss, though further research is needed to fully understand its benefits. Most people can safely engage in this type of exercise, experiencing only minor issues like muscle soreness.

Adaptive brain training has demonstrated the ability to boost memory and thinking skills. It is considered safe for those with mild memory issues, with few reported side effects.

Overall, these activities are non-invasive, and research supports their safety. However, consulting a healthcare provider before starting any new treatment is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine cognitive training with physical exercise, a novel approach for addressing mild cognitive impairment. While traditional treatments often focus on medications like cholinesterase inhibitors, these treatments emphasize enhancing brain function through natural methods. The combined arm uses adaptive cognitive training alongside progressive aerobic exercise, providing a dual approach to potentially improve memory and cognitive skills. This method targets both the brain and body, setting it apart from standard medication-focused therapies.

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

This trial will compare different approaches to improving brain health in individuals with mild cognitive impairment. Participants in one arm will engage in a combination of aerobic exercise and brain training. Research shows this combination can boost brain function by strengthening different brain areas, leading to better thinking skills. Another arm will focus on aerobic exercise alone. Studies suggest this can slow memory and thinking problems and improve overall brain health, potentially preventing mild memory issues from progressing to dementia. A third arm will involve brain training exercises, which have been shown to improve memory and focus in people with mild memory problems. Whether used together or separately, these activities aim to improve brain health and protect against further memory and thinking decline. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 50-80 with mild cognitive impairment (MCI), who are sedentary, fluent in English, and can use an iPad or computer. They must be able to live independently despite cognitive deficits. Those with a BMI over 40, severe medical conditions, or inability to undergo MRI due to metal implants or claustrophobia cannot participate.

Inclusion Criteria

Primary caregivers will be interviewed to corroborate independent functional status

I have been diagnosed with mild cognitive impairment but can still take care of myself.

I exercise less than 3 times a week.

Exclusion Criteria

Estimated verbal IQ below 70, self-reported moderate to severe substance use disorder(s), severe chronic or acute medical or neuropsychiatric conditions that might confound measures, body mass index >40 kg/m2

Unable to undergo MRI investigation due to claustrophobia or metal foreign bodies

I cannot access a computer or internet for training and won't go to the lab.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week intervention combining brain training and aerobic exercise

12 weeks

3 visits per week for aerobic exercise, 5 visits per week for cognitive training

Follow-up

Participants are monitored for changes in brain structure, function, and cognitive performance

4 weeks

1 visit (in-person) for assessments

What Are the Treatments Tested in This Trial?

Interventions

• Adaptive cognitive training
• Combined
• Progressive aerobic exercise

Trial Overview The study tests if brain function improves after a combined 12-week program of brain training and aerobic exercise in people with MCI. It explores potential treatments for dementia by assessing changes in the brain and cognition through this dual intervention approach.

How Is the Trial Designed?

Group I: Combined Cognitive and Aerobic Exercise Experimental Treatment 1 Intervention

Combined progressive aerobic exercise 3x/week for 12 weeks and adaptive cognitive training on Cogmed 5x/week for a total of 25 sessions in 5-8 weeks simultaneously.

Group II: Cognitive Training Experimental Treatment 1 Intervention

Adaptive cognitive training on Cogmed 5x/week for a total of 25 sessions in 5-8 weeks.

Group III: Aerobic Exercise Experimental Treatment 1 Intervention

Progressive aerobic exercise 3x/week for 12 weeks.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

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]

Combining structured aerobic exercise with cognitive training in adult stroke patients shows potential for improving cognitive function, with all five studies reviewed reporting some level of cognitive improvement after the intervention.

While the combined approach appears to offer greater benefits compared to either intervention alone, further research with long-term follow-up and standardized cognitive assessments is needed to confirm these findings and fully understand the effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Combined Interventions with Aerobic Physical Exercise and Cognitive Training on Cognitive Function in Stroke Patients: A Systematic Review. Amorós-Aguilar, L., Rodríguez-Quiroga, E., Sánchez-Santolaya, S., et al.[2021]

The SMART trial will investigate the effects of cognitive training (CT) and progressive resistance training (PRT) on cognitive function and independence in 132 older adults at risk for cognitive decline, using a double-blind, randomized design over 6 months.

This study aims to identify not only the cognitive benefits of these interventions but also their impact on brain health, physical fitness, and overall well-being, potentially revealing mechanisms that contribute to slowing cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of Mental Activity and Regular Training (SMART) in at risk individuals: a randomised double blind, sham controlled, longitudinal trial. Gates, NJ., Valenzuela, M., Sachdev, PS., et al.[2022]

A 6-month aerobic training program significantly improved executive functions in adults with Subcortical Ischemic Vascular Cognitive Impairment (SIVCI) who had low cardiovascular risk, as measured by tests for response inhibition and set shifting.

However, for those with high cardiovascular risk, aerobic training did not lead to cognitive improvements, indicating that pre-existing cardiovascular health can limit the benefits of exercise on cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular risk moderates the effect of aerobic exercise on executive functions in older adults with subcortical ischemic vascular cognitive impairment. Barha, CK., Dao, E., Marcotte, L., et al.[2022]

A study involving 32 healthy elderly participants showed that both aerobic training and mental training significantly improved cognitive function, particularly in memory and learning scores, after a two-month training period.

The combination of aerobic and mental training resulted in even greater improvements in cognitive function compared to either training method alone, suggesting that integrating both approaches may be more effective for enhancing cognitive abilities in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of cognitive function by mental and/or individualized aerobic training in healthy elderly subjects. Fabre, C., Chamari, K., Mucci, P., et al.[2022]

A 12-month aerobic exercise training (AET) program improved cardiorespiratory fitness in patients with amnestic mild cognitive impairment (aMCI), but did not show significant differences in memory and executive function compared to a stretching and toning control group.

In patients with amyloid positivity, AET was associated with reduced hippocampal atrophy, suggesting a potential protective effect against brain volume loss, even though both AET and control groups experienced increases in cortical amyloid-β deposition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training in Amnestic Mild Cognitive Impairment: A One-Year Randomized Controlled Trial. Tarumi, T., Rossetti, H., Thomas, BP., et al.[2020]

A 6-month randomized controlled trial will assess the effects of aerobic training (AT), resistance training (RT), and their combination on cognitive function in 216 older adults (ages 65-85) with mild cognitive impairment (MCI).

The study aims to determine how different types of exercise can help prevent cognitive decline and potentially delay the onset of dementia, highlighting the importance of exercise as a therapeutic intervention for cognitive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reshaping the path of mild cognitive impairment by refining exercise prescription: a study protocol of a randomized controlled trial to understand the "what," "for whom," and "how" of exercise to promote cognitive function. Barha, CK., Falck, RS., Best, JR., et al.[2022]

The MEMO+ study is a randomized controlled trial involving 162 participants with mild cognitive impairment (MCI) to evaluate the efficacy of cognitive training and psychosocial interventions over an eight-week period.

The study aims to measure both immediate and long-term effects on cognitive function and daily living skills, potentially leading to improved well-being for individuals with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the impact of cognitive and psychosocial interventions in persons with mild cognitive impairment with a randomized single-blind controlled trial: rationale and design of the MEMO+ study. Bier, N., Grenier, S., Brodeur, C., et al.[2022]

In a study of 1,087 service members and veterans with a history of mild traumatic brain injury (mTBI), no significant differences in cognitive performance were found across varying levels of aerobic physical activity, suggesting that exercise may not directly enhance cognitive function in this population.

However, individuals engaging in regular aerobic activity reported higher life satisfaction and overall health, indicating that while exercise may not improve cognitive tests, it positively impacts subjective well-being for those with chronic mTBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relation of Aerobic Activity to Cognition and Well-being in Chronic Mild Traumatic Brain Injury: A LIMBIC-CENC Study. Wright, BM., Zhang, C., Fisher, RR., et al.[2023]

An 8-week intervention combining aerobic exercise and cognitive training significantly improved attention in chronic stroke survivors with cognitive impairment, as evidenced by reduced attention errors immediately after the intervention and at a 3-month follow-up.

Despite the cognitive improvements, there was no significant change in cardiorespiratory fitness, indicating that the cognitive benefits may arise specifically from the training rather than improvements in physical fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiorespiratory fitness and cognitive functioning following short-term interventions in chronic stroke survivors with cognitive impairment: a pilot study. Blanchet, S., Richards, CL., Leblond, J., et al.[2018]

The SYNERGIC trial is a comprehensive study involving 200 older adults with Mild Cognitive Impairment (MCI) that aims to evaluate the combined effects of aerobic exercise, resistance training, cognitive training, and vitamin D supplementation on cognitive function and mobility over a 6-month period.

This trial will assess various outcomes, including cognitive performance using the ADAS-Cog scale and biomarkers related to inflammation and neuroplasticity, potentially leading to new strategies for managing cognitive decline in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SYNERGIC TRIAL (SYNchronizing Exercises, Remedies in Gait and Cognition) a multi-Centre randomized controlled double blind trial to improve gait and cognition in mild cognitive impairment. Montero-Odasso, M., Almeida, QJ., Burhan, AM., et al.[2019]

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