NCT04607317

Exercise as Adjunctive Treatment for Refractory Epilepsy

A Telehealth Physical Exercise Intervention for the Treatment of Drug Resistant Epilepsy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Refractory Epilepsy
• Epilepsy

Interventions

Type	Name	Description
BEHAVIORAL	Exercise program	a telehealth-delivered exercise program with the goal of progressing to 150 min/week (5 days per week, 30 minutes of steady state walking per day)
BEHAVIORAL	Health Coach	The coach will work directly with each participant during their once-weekly virtual 1:1 meeting to progress intensity and duration. Participants will meet with the coach to review a brief social cognitive theory-based module, which will provide education on core behavior change concepts and the benefits of physical activity for those with epilepsy. The coach will review the previous week's exercise during meetings, and will then work with the participant to revise and reset goals for the coming week.
BEHAVIORAL	Health Information	Participants will be contacted by a study coordinator via telephone every 2 weeks for health education. During this time, they will review resources and healthy lifestyle guidelines for people with epilepsy, including healthy diet, medication compliance, seizure precautions, stress management, and sleep hygiene.

Timeline

• Start date: 2021-04-13
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2020-10-29
• Last updated: 2022-12-07

Locations

1 site across 1 country: United States