Exercise as Adjunctive Treatment for Refractory Epilepsy

Wake Forest University (WFU)

Status: Terminated

Conditions: Epilepsy; Refractory Epilepsy

Treatments: Behavioral: Health Information; Behavioral: Health Coach; Behavioral: Exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT04607317

IRB00068408

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10 participants in 2 patient groups

Exercise Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Health Coach

Behavioral: Exercise program

Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Health Information