Exercise for Mild Cognitive Impairment

Not currently recruiting at 5 trial locations

Overseen By Karishma Ramdeo, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Transcranial magnetic stimulation, Exercise, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise might improve brain function in people with Mild Cognitive Impairment (MCI) and older adults. Researchers aim to determine if exercise can alter synaptic plasticity (how brain cells connect and communicate) and enhance thinking skills. Participants will either engage in Self-determined Intensity Interval Training on a stationary bike or refrain from exercise to compare results. Individuals diagnosed with MCI are well-suited for this study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on exercise and brain 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 exercise protocol is safe for individuals with Mild Cognitive Impairment?

Research shows that exercise, such as Self-determined Intensity Interval Training, is generally safe for people. Studies on similar high-intensity interval training (HIIT) programs have found that participants, including older adults, handle them well. For instance, one study found that HIIT improved thinking skills and positively affected blood pressure in older adults. Another study examined how people with serious mental illnesses managed HIIT and found it was feasible, suggesting it can be safely adjusted for different groups.

While personal health conditions should always be considered, the evidence so far supports that this type of exercise can safely and effectively boost brain function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of exercise, specifically Self-determined Intensity Interval Training, for individuals with Mild Cognitive Impairment (MCI). Unlike current treatments that often rely on medications to manage symptoms, this protocol emphasizes a non-pharmacological approach that empowers participants to control their exercise intensity using their perceived exertion levels. This innovative approach could offer a more personalized and engaging way to help improve cognitive function. The trial aims to uncover whether regular, tailored exercise can provide cognitive benefits, which could be a game-changer for people with MCI looking for alternative or complementary strategies to support brain health.

What evidence suggests that Self-determined Intensity Interval Training might be an effective treatment for Mild Cognitive Impairment?

This trial will evaluate the effects of Self-determined Intensity Interval Training on individuals with Mild Cognitive Impairment (MCI). Studies have shown that exercise can improve thinking and memory, especially in older adults with MCI. Research suggests that high-intensity interval training (HIIT), similar to the exercise in this trial, is particularly helpful. It enhances brain function and could be a promising non-drug option. Reviews combining results from many studies show that exercise has a clear positive effect on thinking skills in older adults with MCI. In short, exercise not only keeps the body healthy but also helps keep the mind sharp. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with mild cognitive impairment (MCI) or those experiencing normal aging who want to improve their cognition. Participants should be able to perform physical exercise and not have any conditions that would prevent them from receiving repetitive transcranial magnetic stimulation.

Inclusion Criteria

I have been diagnosed with mild cognitive impairment.

Exclusion Criteria

I have no conditions that prevent me from undergoing magnetic brain stimulation.

Contradictions to performing physical exercise

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Exercise Intervention

Participants engage in Self-Determined Intensity Interval Training using a cycle ergometer for 4 weeks

4 weeks

3 sessions per week

Follow-up

Participants are monitored for changes in synaptic plasticity, BDNF, osteocalcin, and cognitive function

1-2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Self-determined Intensity Interval Training

Trial Overview The study tests if self-determined intensity interval training, a form of exercise, can change synaptic plasticity in the brain. This could relate to improved thinking abilities in both healthy older adults and those with MCI.

How Is the Trial Designed?

Group I: Exercise Training in Individuals with Mild Cognitive Impairment Active Control 1 Intervention

Individuals will participate in 3 sessions of Self Determined Intensity Interval training per week for 4 weeks, using a stationary bike at an intensity whereby their Ratings of Perceived exertion (RPE) is challenging. RPE will be measured using a Borg's 6-20 scale. (44). The cycling protocol will include a 3-minute warm-up, five, 1-minute cycling intervals, interspersed with 1.5 minutes of recovery. and a 2-minute cool-down. The RPE will be acquired by asking the participant to provide their rating at the end of the last interval.

Group II: Individuals with Mild Cognitive Impairment and No exercise Active Control 1 Intervention

Group B: Participants in this arm will not experience any intervention during a 4 week period of time.

Group III: Exercise Training in age and sex matched healthy controls Active Control 1 Intervention

Individuals will participate in 3 sessions of Self Determined Intensity Interval training per week for 4 weeks, using a stationary bike at an intensity whereby their Ratings of Perceived exertion (RPE) is challenging. RPE will be measured using a Borg's 6-20 scale. (44). The cycling protocol will include a 3-minute warm-up, five, 1-minute cycling intervals, interspersed with 1.5 minutes of recovery. and a 2-minute cool-down. The RPE will be acquired by asking the participant to provide their rating at the end of the last interval.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

McMaster Institute for Research in Aging

Collaborator

Trials

1

Recruited

40+

Canada Research Chair

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

High-Intensity Interval Training (HIIT) is a time-efficient exercise method that may provide similar or superior cardiovascular and cerebrovascular benefits compared to Moderate-Intensity Continuous Training (MICT), which is important for preventing neurovascular diseases in older adults.

Despite the known benefits of MICT, there is a lack of randomized controlled trials (RCTs) specifically examining the effects of HIIT on brain health, highlighting the need for future research to explore its potential neuroprotective effects in an aging population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIITing the brain with exercise: mechanisms, consequences and practical recommendations. Calverley, TA., Ogoh, S., Marley, CJ., et al.[2021]

One year of moderate-to-vigorous intensity aerobic exercise training (AET) improved cardiorespiratory fitness and increased hypocapnic cerebral vasomotor reactivity (CVMR) in patients with amnestic mild cognitive impairment (MCI).

Changes in hypercapnic CVMR were associated with improved cognitive performance, particularly in memory and executive function, suggesting that AET may enhance cerebrovascular function and cognitive health in older adults at risk for Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year aerobic exercise altered cerebral vasomotor reactivity in mild cognitive impairment. Tomoto, T., Tarumi, T., Chen, JN., et al.[2023]

High-intensity interval training (HIIT) is as effective, if not more so, than traditional moderate-intensity continuous training (MICT) for patients with cardiovascular disease, based on a systematic review of 23 studies involving 1117 participants.

The safety profile of HIIT in cardiac rehabilitation is promising, with only one major cardiovascular adverse event reported per 17,083 training sessions, indicating that HIIT can be safely implemented in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. Wewege, MA., Ahn, D., Yu, J., et al.[2021]

High-intensity interval training (HIIT) has been shown to significantly improve various health outcomes, including cardiorespiratory fitness, muscle mass, and mental health indicators like anxiety and depression, across diverse populations, as evidenced by 33 systematic reviews involving both healthy individuals and those with health complications.

HIIT is considered safe, with no reported acute injuries and high adherence rates exceeding 80%, suggesting it is a feasible exercise option for many people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can high-intensity interval training improve physical and mental health outcomes? A meta-review of 33 systematic reviews across the lifespan. Martland, R., Mondelli, V., Gaughran, F., et al.[2023]

A systematic review of 27 studies involving 2565 participants with mild cognitive impairment (MCI) found that physical and mental exercises, such as Tai Chi and dance, significantly improved cognitive performance, as indicated by various cognitive assessment scores.

These exercises not only enhanced cognitive abilities but also positively affected biomarkers, increasing levels of the beneficial αβ1-42 protein and decreasing Tau protein levels, suggesting a potential mechanism for their efficacy in managing MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mind-body exercise on cognitive performance in middle-aged and older adults with mild cognitive impairment: A meta-analysis study. Cai, H., Zhang, K., Wang, M., et al.[2023]

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]

This study aims to determine if interval training on a cycle ergometer can enhance synaptic plasticity in individuals with mild cognitive impairment (MCI), involving 24 participants over a 4-week exercise program.

If successful, the research could show that exercise not only improves cognitive function but also modifies neural plasticity, potentially leading to new treatment strategies for MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Exercise on Synaptic Plasticity in Individuals With Mild Cognitive Impairment: Protocol for a Pilot Intervention Study. Ramdeo, KR., Fahnestock, M., Gibala, M., et al.[2023]

High-intensity interval training (HIIT) is an efficient exercise strategy that can provide similar or even superior health benefits compared to traditional aerobic exercise, making it a time-saving option for improving overall health.

Recent studies suggest that HIIT may be particularly effective in enhancing cognitive function and could serve as a rehabilitation therapy for cognitive impairments related to obesity, diabetes, stroke, and dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research advances on high-intensity interval training and cognitive function]. Hu, JY., Cai, M., Shang, QH., 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]

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]

In a study of 113 older adults with Mild Cognitive Impairment (MCI), a 7-month combined physical-cognitive training program significantly improved cognitive status compared to those who did not receive training.

The training also increased cerebral blood flow in the parahippocampal area, suggesting a positive impact on brain health, while no significant effect on gray matter volume loss was observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial on the effects of a combined physical/cognitive training in aged MCI subjects: the Train the Brain study. [2018]

The BRAIN Training Trial is investigating the effects of high-intensity aerobic interval training (HIIT) and high-intensity power training (POWER) on cognitive function in 160 older adults (≥ 60 years) with mild cognitive impairment (MCI) over 12 months, aiming to provide clearer insights into effective exercise interventions for cognitive health.

The primary outcome will be assessed through a cognitive composite score at baseline, 6 months, and 12 months, which will help determine if these high-intensity exercise programs can significantly improve cognitive performance compared to a sham exercise control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for the BRAIN Training Trial: a randomised controlled trial of Balance, Resistance, And INterval training on cognitive function in older adults with mild cognitive impairment. Valenzuela, T., Coombes, JS., Liu-Ambrose, T., et al.[2023]

A systematic review of 11 studies with 1497 participants found that aerobic exercise significantly improves global cognitive ability in older adults with mild cognitive impairment, as measured by the Mini-Mental State Examination and Montreal Cognitive Assessment scores.

While aerobic exercise showed a small positive effect on memory recall, no significant improvements were observed in other cognitive domains, indicating that while beneficial, the effects of exercise on cognition may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise ameliorates cognitive function in older adults with mild cognitive impairment: a systematic review and meta-analysis of randomised controlled trials. Zheng, G., Xia, R., Zhou, W., et al.[2022]

Citations

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Summary of the effect of an exercise intervention on elderly ... The results of the meta-analysis revealed that exercise had positive effects on cognitive function in elderly with MCI and was statistically ...

2. nature.com nature.com/articles/s41598-024-83802-9

The effects of high-intensity interval training on cognitive ... The findings of this study indicate that HIIT has a beneficial effect on cognitive performance. Chronic HIIT represents a potential non-pharmacological ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9780390/

The effect of high-intensity interval training on cognitive ... The aim of this study is to examine the effect of aerobic high-intensity interval training (HIIT) on cognitive function and the subsequent effect on treatment ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1728869X2500036X

Feasibility and effects of high-intensity interval training in ... This study provides preliminary evidence on the feasibility and effect of HIIT for older adults with MMD. Both HIIT and MICT-BDJ improved depressive symptoms ...

5. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2021.643809/full

The Benefits of High-Intensity Interval Training on ... We determined the influence of high-intensity interval training (HIIT) combined with mind-motor training on cognition and systolic blood pressure (BP) in older ...

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Study protocol for the BRAIN Training Trial Results from exercise trials for the improvement of cognition in older adults with mild cognitive impairment (MCI) have reported mixed results. This is possibly ...

7. mdpi.com mdpi.com/2077-0383/12/12/4049

Enhancing Cognition in Older Adults with Mild ... Our findings revealed that a 12-week HIFT program improved general cognition in older adults with MCI; similarly, a study conducted on people ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772598724000199

A feasibility study of high intensity interval training ... This study explores the acceptability and feasibility of implementing HIIT amongst inpatients with SMI.