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Exercise for Memory Rehabilitation in Epilepsy

Primary Purpose

Epilepsy, Generalized, Memory Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supervised combined endurance and resistance training (CERT)
Delayed supervised combined endurance and resistance training (CERT)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy, Generalized focused on measuring Epilepsy, Idiopathic Generalized, Memory Impairment, Magnetic Resonance Imaging, Neuroimaging, Endurance and Resistance Training, Resting State Functional Connectivity, Verbal Learning and Memory

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • males and females
  • ages 18-55 years old
  • subjective memory complaint (defined as answering "yes" to the following question: Do you feel that you have problems with your memory, whether it is a result of your epilepsy or due to your anti-seizure medications?)
  • 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
  • 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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Immediate Exercise

Delayed Exercise

Arm Description

immediate participation in 6-week exercise program (intervention)

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 24, 2021
Last Updated
September 20, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04959019
Brief Title
Exercise for Memory Rehabilitation in Epilepsy
Official Title
Exercise for Memory Rehabilitation in Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Exercise
Arm Type
Experimental
Arm Description
immediate participation in 6-week exercise program (intervention)
Arm Title
Delayed Exercise
Arm Type
Other
Arm Description
6-week delay (no-intervention control) prior to participating in exercise program
Intervention Type
Behavioral
Intervention Name(s)
Supervised combined endurance and resistance training (CERT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Delayed supervised combined endurance and resistance training (CERT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
estimated interaction effect between exercise group and visit for d'
Description
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.
Time Frame
6 weeks after baseline
Title
estimated mediation effect of change in left hippocampus resting state functional connectivity (rsFC) in the effect of exercise on change in d'
Description
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.
Time Frame
6 weeks after baseline
Secondary Outcome Measure Information:
Title
estimated interaction effect between exercise group and visit for Learning score
Description
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.
Time Frame
6-weeks after baseline
Title
estimated interaction effect between exercise group and visit for Long Delay Free Recall score
Description
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.
Time Frame
6-weeks after baseline
Title
estimated mediation effect of change in right hippocampus resting state functional connectivity (rsFC) in the effect of exercise on change in d'
Description
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.
Time Frame
6-weeks after baseline
Title
estimated interaction effect between exercise group and visit for Montreal Cognitive Assessment (MoCA) score
Description
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.
Time Frame
6-weeks after baseline
Title
estimated interaction effect between exercise group and visit for Short-Form 36 (SF-36) physical component score
Description
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.
Time Frame
6-weeks after baseline
Title
estimated interaction effect between exercise group and visit for Short-Form 36 (SF-36) mental component score
Description
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.
Time Frame
6-weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Moyana, B.S.
Phone
1-205-975-8446
Email
amoyana@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane B. Allendorfer, Ph.D.
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Moyana, B.S.
Phone
205-975-8446
Email
amoyana@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Jane B. Allendorfer, Ph.D.

12. IPD Sharing Statement

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Exercise for Memory Rehabilitation in Epilepsy

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