Exercise as Adjunctive Treatment for Refractory Epilepsy

  • STATUS
    Recruiting
  • End date
    Jan 24, 2023
  • participants needed
    20
  • sponsor
    Wake Forest University Health Sciences
Updated on 24 March 2022
adjunctive treatment
seizure
generalized epilepsy

Summary

The purpose of this research study is to determine whether a 12-week telehealth aerobic exercise intervention is feasible in people with epilepsy.

The study team will also gather information on the effect of the intervention on sleep and stress as mediators of seizure frequency, well as effects on epilepsy and epilepsy associated comorbidities.

Description

This is a randomized, controlled pilot trial to assess the feasibility and fidelity of a 12 week, individualized, telehealth exercise intervention in people with refractory epilepsy. This will be carried out using a 2 arm, parallel group design with a waitlist attention control.

Participants will undergo formal exercise testing prior to enrollment to determine safety and establish a baseline fitness level. Participants will use a wrist-worn Garmin device to record activity and sleep. After a 4 week baseline period, participants will be randomized to intervention or wait-list attention control. The intervention group will undergo a 12-week telehealth exercise program designed by a trained health coach and tailored to the individual's personal fitness level and exercise preferences. The intervention is based in social cognitive theory to implement and enforce sustainable behavior change. The wait-list attention control will receive health education but will not be given an exercise program. At the end of the intervention period, the control group will be given the option to participate in the exercise program.

The study will assess recruitment and retention as well as fidelity, acceptability and sustainability of a telehealth exercise intervention in this population.

The study will investigate objective and subjective measures of the effect of the intervention on the known seizure triggers of sleep and stress as possible mediators of seizure frequency.

The study will collect information regarding the effects of the intervention on depression, anxiety, quality of life, cognition, and seizure frequency.

Details
Condition Refractory Epilepsy, Epilepsy
Treatment Exercise Program, Health Coach, Health Information
Clinical Study IdentifierNCT04607317
SponsorWake Forest University Health Sciences
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 or older
Focal or generalized epilepsy, as clinically determined by a Wake Forest Baptist Health epileptologist
Seizure frequency of at least 1 clinically observable seizure in the year prior to enrollment
Able to ambulate independently without assistive device
Access to a smartphone with application capabilities
Internet access or cellular data plan to attend virtual sessions

Exclusion Criteria

Diagnosis of nonepileptic or psychogenic spells
Seizures associated with frequent falls with injury
<50% adherence with wearing the device or completing the study diary during the baseline period
Currently in an exercise program
Medical conditions that would limit ability to participate in an exercise intervention such as
Stage III or IV Congestive Heart Failure (CHF)
End-stage Renal Disease
Severe dementia or significant cognitive impairment
Uncontrolled hypertension (HTN)
Motor conditions that limit ambulation
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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