Epilepsy, GeneralizedEMemRENCT04959019
Exercise for Memory Rehabilitation in Epilepsy
A study testing Supervised combined endurance and resistance training (CERT) and Delayed supervised combined endurance and resistance training (CERT) in people with Epilepsy, Generalized and Memory Impairment, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy, Generalized, Memory Impairment
- What is being tested?
- Supervised combined endurance and resistance training (CERT) and Delayed supervised combined endurance and resistance training (CERT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2021to 18 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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).
Read the detailed 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.
- Conditions
- Epilepsy, Generalized, Memory Impairment
- Being tested
- Supervised combined endurance and resistance training (CERT), Delayed supervised combined endurance and resistance training (CERT)
- Keywords
- Epilepsy, Idiopathic Generalized, Memory Impairment, Magnetic Resonance Imaging, Neuroimaging, Endurance and Resistance Training, Resting State Functional Connectivity, Verbal Learning and Memory
- Medical subject headings
- Epilepsy, Generalized, Memory Disorders, Epilepsy, Idiopathic Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised combined endurance and resistance training (CERT)Behavioural
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 supervised combined endurance and resistance training (CERT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Exercise | Experimental | immediate participation in 6-week exercise program (intervention) Receives: Behavioral: Supervised combined endurance and resistance training (CERT) |
| Delayed Exercise | Other | 6-week delay (no-intervention control) prior to participating in exercise program Receives: Behavioral: Delayed supervised combined endurance and resistance training (CERT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks after baseline
Secondary outcomes (9)
estimated interaction effect between exercise group and visit for Learning score
Repeated measures analysis of variance (rm-ANOVA) will be performed to examine condition-by-time interactions for our secondary variable of interest, Learning score, which is the total words recalled immediately after the learning trials on the CVLT-II. Range is negative infinity to positive infinity for estimated interaction effect.
Measured: 6-weeks after baseline
estimated interaction effect between exercise group and visit for Long Delay Free Recall score
Repeated measures analysis of variance (rm-ANOVA) will be performed to examine condition-by-time interactions for our secondary variable of interest, Long Delay Free Recall score, which is the total words recalled 30 minutes after the learning trials on the CVLT-II. Range is negative infinity to positive infinity for estimated interaction effect.
Measured: 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'
Regression tests of mediation for change in right 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.
Measured: 6-weeks after baseline
estimated interaction effect between exercise group and visit for Montreal Cognitive Assessment (MoCA) score
Repeated measures analysis of variance (rm-ANOVA) will be performed to examine condition-by-time interactions for our secondary variable of interest, MoCA score, which is a measure of general cognitive functioning. Range is negative infinity to positive infinity for estimated interaction effect.
Measured: 6-weeks after baseline
estimated interaction effect between exercise group and visit for Short-Form 36 (SF-36) physical component score
Repeated measures analysis of variance (rm-ANOVA) will be performed to examine condition-by-time interactions for our secondary variable of interest, SF-36 physical component score, which is a quality of life subscale measure for physical health. Range is negative infinity to positive infinity for estimated interaction effect.
Measured: 6-weeks after baseline
estimated interaction effect between exercise group and visit for Short-Form 36 (SF-36) mental component score
Repeated measures analysis of variance (rm-ANOVA) will be performed to examine condition-by-time interactions for our secondary variable of interest, SF-36 mental component score, which is a quality of life subscale measure for mental health. Range is negative infinity to positive infinity for estimated interaction effect.
Measured: 6-weeks after baseline
estimated interaction effect between exercise group and visit for Long Delay Cued Recall score
Repeated measures analysis of variance (rm-ANOVA) will be performed to examine condition-by-time interactions for our secondary variable of interest, Long Delay Cued Recall score, which is the total words recalled after being given a cue when tested 30 minutes after the learning trials on the CVLT-II. Range is negative infinity to positive infinity for estimated interaction effect.
Measured: 6 weeks after baseline
estimated interaction effect between exercise group and visit for Short Delay Cued Recall score
Repeated measures analysis of variance (rm-ANOVA) will be performed to examine condition-by-time interactions for our secondary variable of interest, Short Delay Cued Recall score, which is the total words recalled after being given a cue when tested immediately after the learning trials on the CVLT-II. Range is negative infinity to positive infinity for estimated interaction effect.
Measured: 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 Long Delay Cued Recall score
Regression tests of mediation for change in right hippocampus rsFC as the mediator variable in the effect of exercise on change in Long Delay Cued Recall score (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.
Measured: 6-weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start21 Jul 2021
- Primary completion18 Feb 2026
- Study completion18 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, GeneralizedStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jane Allendorfer, University of Alabama at Birmingham
- Investigators
- Jane B. Allendorfer, Ph.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959019
- Sponsor's protocol ID
- IRB-300006833
- Other IDs
- R01HD102723
- Acronym
- EMemRE
- Status last verified
- Mar 2026
- First submitted
- 24 Jun 2021
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise for Memory Rehabilitation in Epilepsy
- ClinicalTrials.gov ID
- NCT04959019
- Acronym / sponsor ID
- EMemRE / IRB-300006833
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 18 Feb 2026 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Exercise | Experimental | Behavioral: Supervised combined endurance and resistance training (CERT)immediate participation in 6-week exercise program (intervention) |
| Delayed Exercise | Other | Behavioral: Delayed supervised combined endurance and resistance training (CERT)6-week delay (no-intervention control) prior to participating in exercise program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- males and females
- ages 18-65 years old
- speaks English fluently
- able to provide written informed consent
- have no contraindications to 3-Telsa MRI
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised combined endurance and resistance training (CERT)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. | Behavioural | Immediate Exercise |
| Delayed supervised combined endurance and resistance training (CERT)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. | Behavioural | Delayed Exercise |
Primary outcome
estimated interaction effect between exercise group and visit for d'
Time frame: 6 weeks after baseline
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.
estimated mediation effect of change in left hippocampus resting state functional connectivity (rsFC) in the effect of exercise on change in d'
Time frame: 6 weeks after baseline
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.
9 secondary outcomes
estimated interaction effect between exercise group and visit for Learning score
Time frame: 6-weeks after baseline
estimated interaction effect between exercise group and visit for Long Delay Free Recall score
Time frame: 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'
Time frame: 6-weeks after baseline
estimated interaction effect between exercise group and visit for Montreal Cognitive Assessment (MoCA) score
Time frame: 6-weeks after baseline
estimated interaction effect between exercise group and visit for Short-Form 36 (SF-36) physical component score
Time frame: 6-weeks after baseline
estimated interaction effect between exercise group and visit for Short-Form 36 (SF-36) mental component score
Time frame: 6-weeks after baseline
estimated interaction effect between exercise group and visit for Long Delay Cued Recall score
Time frame: 6 weeks after baseline
estimated interaction effect between exercise group and visit for Short Delay Cued Recall score
Time frame: 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 Long Delay Cued Recall score
Time frame: 6-weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane B. Allendorfer, Ph.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised combined endurance and resistance training (CERT) and Delayed supervised combined endurance and resistance training (CERT) in people with Epilepsy, Generalized and Memory Impairment, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
estimated interaction effect between exercise group and visit for d' (time frame: 6 weeks after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.