- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04959019
Exercise for Memory Rehabilitation in Epilepsy
February 13, 2024 updated by: Jane Allendorfer, University of Alabama at Birmingham
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).
Study Overview
Status
Recruiting
Conditions
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 Type
Interventional
Enrollment (Estimated)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anna Moyana, B.S.
- Phone Number: 1-205-975-8446
- Email: amoyana@uabmc.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Recruiting
- University of Alabama at Birmingham
-
Contact:
- Anna Moyana, B.S.
- Phone Number: 205-975-8446
- Email: amoyana@uabmc.edu
-
Principal Investigator:
- Jane B. Allendorfer, Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- males and females
- ages 18-55 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)
- no more than 4 seizure days/month in past 6 months
- 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
- >4 seizure days/month in past 6 months
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Exercise
immediate participation in 6-week exercise program (intervention)
|
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.
|
Other: Delayed Exercise
6-week delay (no-intervention control) prior to participating in exercise program
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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'
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.
|
6 weeks after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
estimated interaction effect between exercise group and visit for Learning score
Time Frame: 6-weeks after baseline
|
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.
|
6-weeks after baseline
|
estimated interaction effect between exercise group and visit for Long Delay Free Recall score
Time Frame: 6-weeks after baseline
|
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.
|
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
|
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.
|
6-weeks after baseline
|
estimated interaction effect between exercise group and visit for Montreal Cognitive Assessment (MoCA) score
Time Frame: 6-weeks after baseline
|
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.
|
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
|
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.
|
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
|
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.
|
6-weeks after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jane B. Allendorfer, Ph.D., University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 21, 2021
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
March 31, 2026
Study Registration Dates
First Submitted
June 24, 2021
First Submitted That Met QC Criteria
July 7, 2021
First Posted (Actual)
July 12, 2021
Study Record Updates
Last Update Posted (Actual)
February 14, 2024
Last Update Submitted That Met QC Criteria
February 13, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300006833
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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