Exercise for Memory Rehabilitation in Epilepsy (EMemRE)

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Epilepsy, Generalized; Memory Impairment

Treatments: Behavioral: Supervised combined endurance and resistance training (CERT); Behavioral: Delayed supervised combined endurance and resistance training (CERT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04959019

R01HD102723 (U.S. NIH Grant/Contract)

IRB-300006833

Details and patient eligibility

About

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, investigate the brain changes that may be responsible for memory improvements, and determine if the memory benefits and brain changes are retained 6 weeks after completing the exercise intervention in people with Idiopathic generalized epilepsy (IGE).

Full description

The primary objectives of this randomized controlled trial are to determine in adults with idiopathic generalized epilepsy (IGE) the efficacy of a 6-week supervised and structured exercise program combining endurance and resistance training for memory rehabilitation, investigate a putative mechanisms of action for exercise-related memory benefits, and determine if the memory benefits and brain changes are retained 6 weeks after completing the exercise intervention. Based on the investigators' pilot exercise data in adults with epilepsy, they hypothesize that exercise will significantly improve verbal memory function in the exercise group compared to the no-intervention control group. The investigators also hypothesize that the verbal memory improvements are mediated by the changes in resting state functional connectivity (rsFC) of the hippocampus, a brain region that plays a vital role in memory function. The investigators propose a mediation model in which exercise-induced changes in the hippocampus rsFC is mediating the beneficial effect of exercise on memory function in epilepsy, and will utilize the causal-steps approach in which 4 conditions of statistical significance must be met to determine if mediation is present.

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• males and females
• ages 18-65 years old
• speaks English fluently
• able to provide written informed consent
• have no contraindications to 3-Telsa MRI
• clinician-confirmed diagnosis of IGE (IGE includes epilepsy syndromes such as juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, and generalized tonic-clonic seizures alone)
• relatively healthy with no comorbid medical conditions besides epilepsy
• normal pre-enrollment structural clinical MRI of the brain (if available)
• having less than the American Heart Association recommendation of physical activity in adults (at least 30 min moderate-intensity aerobic activity at least 5 days/week (150 min total), or at least 25 min vigorous aerobic activity at least 3 days/week (75 min total) and moderate-/high-intensity muscle strengthening activity at least 2 days/week)

Exclusion criteria

• underlying degenerative or metabolic disorders
• abnormal general or neurological examination
• abnormal brain MRI
• recent suicidal ideation in the last 3 months determined based on previous medical history
• pregnant or positive pregnancy test result on the day of the research session
• contraindication to an MRI scan at 3-Telsa
• mental handicap (FSIQ<80 if tested) or history of special education
• concurrent participation in a different intervention study
• diseased or enlarged heart or blood vessels determined based on previous medical history
• high blood pressure that is not controlled by medications
• meeting the American Heart Association recommendation of physical activity in adults
• abnormal physical examination in which study physician determines subject should not participate in the exercise intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 2 patient groups

Immediate Exercise

Experimental group

Description:

immediate participation in 6-week exercise program (intervention)

Treatment:

Behavioral: Supervised combined endurance and resistance training (CERT)

Delayed Exercise

Other group

Description:

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

Treatment:

Behavioral: Delayed supervised combined endurance and resistance training (CERT)