Exercise as Adjunctive Treatment for Refractory Epilepsy

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04607317
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Terminated
Phase	N/A
Start date	April 13, 2021
Completion date	May 31, 2022

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