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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Immediate Exercise 		immediate participation in 6-week exercise program (intervention)
  • Behavioral: 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.
Other
Delayed Exercise 		6-week delay (no-intervention control) prior to participating in exercise program
  • Behavioral: 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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Anna Moyana, B.S.
205-975-8446
amoyana@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Anna Moyana, B.S.
1-205-975-8446
amoyana@uabmc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.