Exercise as Adjunctive Treatment for Refractory Epilepsy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Refractory Epilepsy, Epilepsy

Intervention / Treatment
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* Behavioral: Exercise program
* Behavioral: Health Coach
* Behavioral: Health Information


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to exercise intervention arm or control arm.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Intervention<br>Participants in this arm will be enrolled in 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). Participants will meet weekly 1:1 with a trained health coach via a Webex platform. Weekly exercise goals will be tailored to the individual's abilities and specific barriers. Coaching will utilize social cognitive theory and self-determination theory to develop self-efficacy for sustainable behavior change. | Behavioral: Exercise program<br>* 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)<br>Behavioral: Health Coach<br>* 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.<br>|
| Active Comparator: Control<br>Participants randomized to the wait-list attention control group will continue to undergo standard care for 12 weeks. They will continue to wear the Garmin activity tracker and can view their activity but will not be given an exercise program. They 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. | Behavioral: Health Information<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants recruited | This outcome measure assesses Feasibility of Recruitment. Recruitment will be calculated as a percentage by dividing the total number of enrolled participants by the total number of eligible participants. | Week 0 Baseline | 
| Proportion of participants completing all visits | This outcome measure assesses Feasibility of Retention. Retention will be calculated as the percentage of all participants who complete Visit 2 Week 16 (End of Intervention) out of the total number of participants enrolled. | Visit 3 (Week 16 after Baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants who achieve their target | Fidelity of the Intervention is the proportion of participants in the intervention group who achieve their target HR for at least 80% of their individually prescribed weekly minutes. A priori goal 70% of participants achieve this in at least 10 out of the 12 weeks of the intervention | Visit 3 (Week 16 after Baseline) | 
| Acceptability of the Intervention Questionnaire | This will be a qualitative measure based on post program question of how satisfied the subject was with the exercise intervention with a scale of 1=Very Unsatisfied, 2=Unsatisfied, 3=Neutral, 4=Satisfied, 5=Very Satisfied. Results will include percentage of people who answer 4 or above. | Week 16 and Week 28 after baseline | 
| Percentage of participants achieving the goal for at least 10 weeks | Sustainability of the intervention is defined as maintenance of at least 80% of the last assigned weekly minutes in target HR zone each week. The intervention will be considered sustainable if 60% of the participants achieve this goal for at least 10 out of the 12 follow-up weeks. | Week 28 after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, telehealth, adjunctive treatment