Exercise for Memory Improvement in Epilepsy

(EMemRE Trial)

Overseen By Anna Moyana, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Degenerative disorders, Suicidal ideation, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

114 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a 6-week exercise program can improve memory in individuals with idiopathic generalized epilepsy (IGE), a type of epilepsy with no known cause. Participants will either begin the exercise program, known as supervised combined endurance and resistance training (CERT), immediately or after a 6-week wait, allowing researchers to compare changes. The study also aims to determine if these memory improvements persist after the exercise program concludes. Ideal participants are adults with IGE who engage in less than the recommended amount of weekly physical activity and have no other major health issues. As an unphased trial, this study offers a unique opportunity to contribute to understanding how exercise can benefit memory in epilepsy.

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 is best to discuss this with the study team or your doctor.

What prior data suggests that this exercise program is safe for people with epilepsy?

Research has shown that supervised combined endurance and resistance training (CERT) is generally safe for people with epilepsy. One study found that participants who engaged in this exercise type increased their strength and improved their memory without major issues. Another study found that exercise enhanced memory and brain function, suggesting it might be safe and beneficial. While these studies don't mention specific problems, their focus on positive results is encouraging.

The trial tests exercise, already known to be safe and beneficial for overall health. However, consulting a healthcare provider before starting any new exercise program is crucial, especially for those with epilepsy, to ensure safety and address personal concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise protocol for memory improvement in epilepsy because it offers a non-pharmacological approach to enhancing cognitive function. Unlike traditional treatments for epilepsy, which often focus on medication to control seizures, this exercise regimen combines endurance and resistance training to potentially improve memory. The unique aspect here is the dual approach: participants either begin the exercise program immediately or after a short delay, allowing researchers to better understand the timing and impact of exercise on cognitive health. This trial could pave the way for incorporating physical activity as a complementary strategy to standard epilepsy treatments, offering a holistic option with minimal side effects.

What evidence suggests that this exercise program is effective for improving memory in epilepsy?

Research shows that a combined endurance and resistance training (CERT) program can improve memory in people with epilepsy. In this trial, participants will join one of two groups: the Immediate Exercise group, which begins a 6-week exercise program right away, or the Delayed Exercise group, which starts after a 6-week delay. Studies have found that adults with epilepsy who follow a structured exercise routine experience improvements in memory and thinking skills. Specifically, one study discovered that these participants had better verbal memory, meaning they were more adept at remembering words and language. The exercise program includes endurance activities like walking or cycling, along with strength training to build muscle. These memory improvements likely result from positive changes in the brain due to regular exercise. ^{3 6 7 8 9}

Who Is on the Research Team?

Jane B. Allendorfer, Ph.D.

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-55 with Idiopathic generalized epilepsy (IGE) who are relatively healthy, not very active physically, and have had no more than 4 seizure days per month in the past half year. They must be able to undergo MRI scans and cannot be pregnant or involved in another intervention study.

Inclusion Criteria

Relatively healthy with no comorbid medical conditions besides epilepsy

Speaks English fluently

I have been diagnosed with a type of generalized epilepsy.

Exclusion Criteria

I have a condition that affects my body's normal processes.

Your brain MRI shows abnormal results.

You meet the physical activity recommendations from the American Heart Association for adults.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-week supervised and structured exercise program combining endurance and resistance training for memory rehabilitation

6 weeks

Follow-up

Participants are monitored for memory benefits and brain changes 6 weeks after completing the exercise intervention

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Delayed supervised combined endurance and resistance training (CERT)
• Supervised combined endurance and resistance training (CERT)

Trial Overview The study tests a 6-week supervised exercise program's effectiveness on memory improvement in IGE patients compared to those with no intervention. It also examines brain changes due to the exercise and if improvements persist after six weeks post-intervention.

How Is the Trial Designed?

Group I: Immediate Exercise Experimental Treatment 1 Intervention

immediate participation in 6-week exercise program (intervention)

Group II: Delayed Exercise Experimental Treatment 1 Intervention

6-week delay (no-intervention control) prior to participating in exercise program

Delayed supervised combined endurance and resistance training (CERT) is already approved in United States for the following indications:

Approved in United States as Supervised Combined Endurance and Resistance Training for:

• Memory Rehabilitation in Epilepsy
• Idiopathic Generalized Epilepsy (IGE)

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A 14-day treadmill exercise program in a mouse model of epilepsy showed significant improvements in object and spatial memory, indicating that exercise can enhance cognitive function in epilepsy.

The study revealed that exercise helps protect specific brain cells (parvalbumin interneurons) by reducing neuroinflammation and improving the blood-brain barrier, suggesting a new mechanism for cognitive rehabilitation in epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill exercise improves hippocampal neural plasticity and relieves cognitive deficits in a mouse model of epilepsy. Yu, H., Shao, M., Luo, X., et al.[2023]

Dynamic resistance training can be safely included in cardiac rehabilitation for selected patients, as it does not pose a higher risk than aerobic training when properly supervised and tailored to individual needs.

Low-intensity resistance training (40-60% of maximum voluntary contraction) with controlled repetitions leads to only modest increases in blood pressure, similar to moderate endurance training, making it a viable option for improving muscle strength and cardiovascular health in patients with good cardiac function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for resistance exercise in cardiac rehabilitation. Recommendations of the German Federation for Cardiovascular Prevention and Rehabilitation. Bjarnason-Wehrens, B., Mayer-Berger, W., Meister, ER., et al.[2019]

In a study involving 13 overweight individuals, mixed-intensity interval endurance training (MI-ET) resulted in participants spending a greater percentage of their training time in a favorable heart rate zone compared to traditional continuous endurance training (ET) and circuit-interval resistance training (CRT).

Both MI-ET and CRT led to higher caloric expenditure per minute of exercise than ET, with CRT showing the highest overall caloric burn, but MI-ET provided significant benefits in terms of heart rate training zone engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining matched acute physiological responses to various modes of exercise in individuals who are overweight. Clark, JE.[2016]

In a study involving 15 women with difficult-to-treat epilepsy, a 15-week exercise program significantly reduced seizure frequency and improved overall health, including decreased muscle pain and fatigue.

The positive effects of exercise were not maintained after the program ended, suggesting that ongoing support and structured exercise programs are necessary for long-term benefits in managing epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise in women with intractable epilepsy. Eriksen, HR., Ellertsen, B., Grønningsaeter, H., et al.[2019]

The study developed a 'CORE-CERT checklist' to enhance the replicability of exercise interventions for breast cancer patients, improving reporting quality by about 8% compared to the original CERT guidelines.

Analysis of 29 randomized controlled trials revealed that while the CORE-CERT provided a more precise description of exercise interventions, the overall reporting quality remained insufficient, highlighting the need for better adherence to reporting standards in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CORE-CERT Items as a Minimal Requirement for Replicability of Exercise Interventions: Results From Application to Exercise Studies for Breast Cancer Patients. Bünzen, C., Knuth, J., Bucher, M., et al.[2023]

Concurrent Exercise Training (CET) significantly improves various health markers in people with type 2 diabetes mellitus (T2DM), including glucose levels, body composition, and cardiorespiratory fitness, based on a meta-analysis of six studies involving participants aged 35 to 65 who trained at least twice a week for a minimum of 8 weeks.

CET also positively affects inflammation and lipid profiles, making it a beneficial addition to T2DM management, although the overall evidence may be influenced by biases in the included studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of concurrent exercise training in people with type 2 diabetes: A systematic review and meta-analysis. Zaki, S., Sharma, S., Vats, H.[2023]

The study compared instability circuit resistance training (ICRT) and traditional circuit resistance training (TCRT) in 44 healthy young adults, showing that both training methods significantly improved cardiorespiratory fitness, as indicated by increases in VO2max and peak heart rate (p<0.05).

Both ICRT and TCRT also enhanced muscular fitness, with significant improvements in strength measures like 1RM and peak power during exercises such as back squats and bench presses, demonstrating that using the Borg rating of perceived exertion (RPE) effectively modulated exercise load for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Prescription Using the Borg Rating of Perceived Exertion to Improve Fitness. Garnacho-Castaño, MV., Domínguez, R., Muñoz González, A., et al.[2019]

Isometric resistance training (IRT) has been shown to significantly lower blood pressure by an average of 7.4/3.3 mmHg, which is comparable to the effects of antihypertensive medications, and can reduce the risk of major cardiovascular events by 13% to 22%.

IRT is safe for a variety of patient populations and is particularly beneficial for individuals who cannot engage in aerobic exercise or have resistant hypertension, requiring only about 17 minutes of training per week.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence-based guide to the efficacy and safety of isometric resistance training in hypertension and clinical implications. Baffour-Awuah, B., Pearson, MJ., Dieberg, G., et al.[2023]

Cluster set (CS) resistance training techniques can help older adults and those with health issues by reducing fatigue and improving tolerance to exercise, which may lead to better functional adaptations like increased force and power.

CS techniques are easy to implement in rehabilitation programs without additional costs or extensive training, making them a practical option for enhancing exercise effectiveness in various clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strengthening the Case for Cluster Set Resistance Training in Aged and Clinical Settings: Emerging Evidence, Proposed Benefits and Suggestions. Latella, C., Peddle-McIntyre, C., Marcotte, L., et al.[2021]

A 6-month multicomponent exercise program significantly improved balance and mobility in both normotensive and hypertensive older patients, with 218 participants involved in the study.

The effectiveness of the exercise program was consistent across different age groups, indicating that aging does not hinder the ability to adapt to exercise in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Multicomponent Exercise on Functional and Cognitive Parameters of Hypertensive Patients: A Quasi-Experimental Study. Coelho Junior, HJ., Rodrigues, B., Feriani, DJ., et al.[2020]

Regular physical exercise can help reduce seizures in about 30-40% of people with epilepsy, but for around 10%, intense exercise might actually trigger seizures, especially in those with poor fitness levels.

It's important for individuals with epilepsy to engage in physical activities tailored to their specific condition, considering their seizure type and frequency, to ensure safety and maximize benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Should people with epilepsy exercise?]. Nakken, KO.[2008]

In a pilot study involving 17 participants with epilepsy, a 6-week exercise rehabilitation program led to significant improvements in verbal memory performance and changes in brain connectivity related to memory processes.

The exercise group showed increased strength and changes in resting state functional connectivity in brain regions associated with memory, suggesting that exercise may enhance cognitive function in people with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of combined endurance and resistance exercise rehabilitation for verbal memory and functional connectivity improvement in epilepsy. Allendorfer, JB., Brokamp, GA., Nenert, R., et al.[2020]

A 12-week structured exercise program significantly reduced seizure frequency in people with epilepsy, with a notable decrease observed in the exercise group compared to the control group (p = 0.010).

Participants in the exercise group also experienced improvements in quality of life, stress levels, and physical fitness, indicating that regular physical activity can enhance overall health for individuals with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an exercise program on health of people with epilepsy: A randomized clinical trial. Häfele, CA., Rombaldi, AJ., Feter, N., et al.[2021]

Citations

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Exercise for Memory Rehabilitation in Epilepsy A 6-week supervised and structured exercise program combining endurance and resistance training for memory rehabilitation.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525505019301994

A pilot study of combined endurance and resistance ... We conclude that a structured supervised exercise program consisting of intensive endurance and strength training is feasible for adults with epilepsy and that ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04959019

Exercise for Memory Rehabilitation in Epilepsy The purpose of this study is to determine how effective a 6-week exercise program is for improving memory compared to a no-intervention control group, ...

4. omsorgsforskning.brage.unit.no omsorgsforskning.brage.unit.no/omsorgsforskning-xmlui/bitstream/handle/11250/2602191/Allendorfer.pdf?sequence=1&isAllowed=y

Epilepsy & Behavior Thus, in this pilot study, we examined the effects of supervised, combined endurance and resistance exercise rehabilita- tion on verbal memory function in PWE ...

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A pilot study of combined endurance and resistance ... A study has shown that adults with epilepsy who underwent supervised training that included aerobic exercise showed overall improved memory and cognitive ...

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A pilot study of combined endurance and resistance ... Persons with epilepsy that participated in exercise intervention increased maximum voluntary strength (all strength tests p < 0.05) and exhibited ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11450595/

Proceedings of the 2022 “Lifestyle Intervention for Epilepsy ... Combined endurance and resistance exercise improved verbal learning, memory, and functional connectivity in adults with epilepsy. The change in verbal memory ...

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Exercise Education for Adults With Seizure Disorders ... The effect of the E-MOVE intervention on seizure frequency based on seizure calendar self-report, quality of life scores, symptoms of depression and BMI ...

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Examining the role of physical activity in older adults with ... PA may reduce the incidence of epilepsy in older adults. Existing evidence shows PA prevents falls and reduces neuroinflammation.