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

Trial Summary

What is the purpose of this trial?

The prevalence of dementia will double in the next three decades in the U.S.; effective treatment or prevention for dementia is urgently needed. The current exploratory project aims to evaluate and understand how the brain and cognition may improve after a 12-week intervention that combines brain training and aerobic exercise training to improve brain function, both in those with mild cognitive impairment (some with possible prodromal Alzheimer's disease) and with healthy aging. Findings from this pilot project will guide and refine the development of a future larger clinical trial that aligns with the goals of the National Alzheimer's Plan of Action (NAPA), especially regarding "Prevent and Effectively Treat Alzheimer's Disease (AD) by 2025.

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 data supports the effectiveness of the treatment Adaptive cognitive training, Brain Training, Cognitive Training, Neurocognitive Training, Combined, Combined Brain Training and Aerobic Exercise Training, Progressive aerobic exercise, Aerobic exercise, Physical activity, Cardiovascular exercise for Mild Cognitive Impairment?

Research suggests that cognitive training can improve thinking skills and delay cognitive decline in older adults with mild cognitive impairment. Additionally, aerobic exercise has been shown to enhance cognitive function in older adults, particularly when combined with cognitive training, as seen in studies involving individuals with cognitive impairments. ^{1 2 3 4 5}

Is exercise and cognitive training safe for humans?

Research on exercise and cognitive training, including aerobic exercise and mental training, generally suggests these activities are safe for humans. Studies involving healthy elderly subjects and individuals with mild cognitive impairment or stroke have not reported significant safety concerns. ^{1 6 7 8 9}

How is the treatment of exercise and cognitive training for mild cognitive impairment different from other treatments?

This treatment is unique because it combines physical exercise with cognitive training, potentially enhancing brain health more effectively than either approach alone. The combination aims to improve cognitive function by engaging both the body and mind, which may offer synergistic benefits not seen with standard treatments. ^{1 2 3 10 11}

Eligibility Criteria

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

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

I am between 50 and 80 years old.

Ability to use and accessibility to an iPad or computer

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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 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]

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]

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]

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]

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 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]

References

1. England 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. [2022]

2. England 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. [2022]

3. England 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Cardiorespiratory fitness and cognitive functioning following short-term interventions in chronic stroke survivors with cognitive impairment: a pilot study. [2018]

5. England 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. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Improvement of cognitive function by mental and/or individualized aerobic training in healthy elderly subjects. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Relation of Aerobic Activity to Cognition and Well-being in Chronic Mild Traumatic Brain Injury: A LIMBIC-CENC Study. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise Training in Amnestic Mild Cognitive Impairment: A One-Year Randomized Controlled Trial. [2020]

9. Switzerland 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. [2021]

10. Switzerland 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. [2022]

11. England 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. [2019]