Exercise for Memory Rehabilitation in Epilepsy

NCT04959019 | Completed

• 2 other identifiers: IRB-300006833R01HD102723
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Epilepsy, Generalized; Memory Impairment

Keywords

Epilepsy, Idiopathic Generalized; Memory Impairment; Magnetic Resonance Imaging; Neuroimaging; Endurance and Resistance Training; Resting State Functional Connectivity; Verbal Learning and Memory

Outcome Measures

Primary Outcomes (2)

• estimated interaction effect between exercise group and visit for d'

  Repeated measures analysis of variance (rm-ANOVA) will be performed to examine condition-by-time interactions for our primary variable of interest, d', which is the discriminability index for delayed recognition memory on the California Verbal Learning Test - II (CVLT-II). Range is negative infinity to positive infinity for estimated interaction effect.

  6 weeks after baseline

• estimated mediation effect of change in left hippocampus resting state functional connectivity (rsFC) in the effect of exercise on change in d'

  Regression tests of mediation for change in left hippocampus rsFC as the mediator variable in the effect of exercise on change in d' (from CVLT-II) will be performed using the causal-steps approach. The four steps in the causal process must be true for mediation to be present. Range is negative infinity to positive infinity for estimated mediation effect.

  6 weeks after baseline

Secondary Outcomes (9)

• estimated interaction effect between exercise group and visit for Learning score

  6-weeks after baseline

• estimated interaction effect between exercise group and visit for Long Delay Free Recall score

  6-weeks after baseline

• estimated mediation effect of change in right hippocampus resting state functional connectivity (rsFC) in the effect of exercise on change in d'

  6-weeks after baseline

• estimated interaction effect between exercise group and visit for Montreal Cognitive Assessment (MoCA) score

  6-weeks after baseline

• estimated interaction effect between exercise group and visit for Short-Form 36 (SF-36) physical component score

  6-weeks after baseline

Study Arms (2)

Immediate Exercise

EXPERIMENTAL

immediate participation in 6-week exercise program (intervention)

Behavioral: Supervised combined endurance and resistance training (CERT)

Delayed Exercise

OTHER

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

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

Interventions

Supervised combined endurance and resistance training (CERT) BEHAVIORAL

Subjects will undergo up to 18 supervised sessions of a structured exercise program of combined endurance and resistance training (CERT). Supervised CERT will occur for 3 days/week, approx. 1 hr per session. Endurance training will start at 15 minutes and progress to 30 minutes of cycling on a stationary recumbent bicycle at 65-85% of heart rate reserve by week 3. Resistance training volume and intensity (baseline determined from strength tests) will progress over the first four sessions to 3 sets of 8-12 repetitions to volitional fatigue for 8 movements, with alternating upper-body and lower-body movements during the session. Progression will be incorporated throughout the trial for both endurance and resistance training to maintain relative intensity.

Immediate Exercise

Delayed supervised combined endurance and resistance training (CERT) BEHAVIORAL

After a 6-week delay period (no-exercise control), subjects will undergo up to 18 supervised sessions of a structured exercise program of combined endurance and resistance training (CERT). Supervised CERT will occur for 3 days/week, approx. 1 hr per session. Endurance training will start at 15 minutes and progress to 30 minutes of cycling on a stationary recumbent bicycle at 65-85% of heart rate reserve by week 3. Resistance training volume and intensity (baseline determined from strength tests) will progress over the first four sessions to 3 sets of 8-12 repetitions to volitional fatigue for 8 movements, with alternating upper-body and lower-body movements during the session. Progression will be incorporated throughout the trial for both endurance and resistance training to maintain relative intensity.

Delayed Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Epilepsy, Generalized; Memory Disorders; Epilepsy, Idiopathic Generalized

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jane B. Allendorfer, Ph.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study utilizes a randomized delayed intervention study design. Participants are randomized to a 6-week exercise program (intervention), or to a 6-week delay (no-intervention control) prior to beginning the exercise program.

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 12, 2021
• Study Start: July 21, 2021
• Primary Completion: February 18, 2026
• Study Completion: February 18, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)