Exercise for Memory Improvement in Epilepsy

(EMemRE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jane B. Allendorfer, Ph.D.

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Disqualifiers: Degenerative disorders, Suicidal ideation, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if an exercise program can improve memory in adults with epilepsy by making their brain work better, especially the part that helps with remembering things.

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 data supports the effectiveness of the treatment Delayed supervised combined endurance and resistance training (CERT) for memory improvement in epilepsy?

Research shows that combining endurance and resistance training can improve physical function and cognitive abilities in various conditions, such as hypertension and type 2 diabetes. This suggests that similar exercise programs might also benefit memory and cognitive function in people with epilepsy. ^{1 2 3 4 5}

Is exercise, including combined endurance and resistance training, generally safe for humans?

Exercise, including combined endurance and resistance training, is generally safe for humans when properly supervised and tailored to individual health conditions. Studies show that such exercise can be safely included in rehabilitation programs for various conditions, like cardiac rehabilitation, with appropriate precautions and supervision. ^{1 3 6 7 8}

How does the Delayed supervised combined endurance and resistance training (CERT) treatment for memory improvement in epilepsy differ from other treatments?

This treatment is unique because it combines endurance and resistance exercises to improve memory and brain function in people with epilepsy, which is not a standard approach for this condition. It focuses on enhancing physical fitness and brain connectivity, potentially leading to better memory performance. ^{9 10 11 12 13}

Research Team

Jane B. Allendorfer, Ph.D.

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Findings from Research

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]

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]

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]

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]

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 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]

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]

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 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. New Zealand pubmed.ncbi.nlm.nih.gov

Strengthening the Case for Cluster Set Resistance Training in Aged and Clinical Settings: Emerging Evidence, Proposed Benefits and Suggestions. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Recommendations for resistance exercise in cardiac rehabilitation. Recommendations of the German Federation for Cardiovascular Prevention and Rehabilitation. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Multicomponent Exercise on Functional and Cognitive Parameters of Hypertensive Patients: A Quasi-Experimental Study. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of concurrent exercise training in people with type 2 diabetes: A systematic review and meta-analysis. [2023]

6. United States 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. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Exercise Prescription Using the Borg Rating of Perceived Exertion to Improve Fitness. [2019]

8. England pubmed.ncbi.nlm.nih.gov

An evidence-based guide to the efficacy and safety of isometric resistance training in hypertension and clinical implications. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A pilot study of combined endurance and resistance exercise rehabilitation for verbal memory and functional connectivity improvement in epilepsy. [2020]

10. India pubmed.ncbi.nlm.nih.gov

Treadmill exercise improves hippocampal neural plasticity and relieves cognitive deficits in a mouse model of epilepsy. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Effects of an exercise program on health of people with epilepsy: A randomized clinical trial. [2021]

12. Norway pubmed.ncbi.nlm.nih.gov

[Should people with epilepsy exercise?]. [2008]

13. United States pubmed.ncbi.nlm.nih.gov

Physical exercise in women with intractable epilepsy. [2019]