Steps for Epilepsy (StEpi)

Wake Forest University (WFU)

Status: Completed

Conditions: Epilepsy

Treatments: Behavioral: 12-week Physical Activity Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05359003

IRB00084252

UL1TR001420 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this research study is to evaluate the feasibility of a 12-week, telehealth delivered, step-goal based physical activity intervention in people with epilepsy. The study team will also evaluate the physical activity profiles of people with epilepsy both at rest and when engaged in physical activity and gather information on the effect of the intervention on epilepsy and epilepsy associated comorbidities.

Full description

This is a randomized, controlled, pilot trial to assess the feasibility of a 12-week telehealth delivered, step-goal based physical activity intervention in people with epilepsy. This will be carried out using a 2-arm, parallel group design with a healthy living education control. Participants will undergo formal exercise testing to establish a baseline fitness level and safety of participation. They will wear Garmin activity tracker on their wrist throughout the study to track their steps. During a 4 week baseline period, we will gather data on baseline physical activity levels and seizure frequency. Participants will then be randomized to either the intervention group or a healthy living education control group. The intervention group will undergo a 12-week, telehealth delivered, step goal based physical activity intervention with a goal of ultimately achieving at least 8,000 steps per day. The intervention will utilize social cognitive theory to encourage lasting behavior changes and have weekly group coaching sessions with a trained health and behavior change provider. The control group will receive education every two weeks but will not be given a coaching plan. The study will evaluate adherence to the intervention, sustainability of the intervention over 12 weeks after the formal coaching program ends, and acceptability of the intervention. The study will also investigate the physical activity profile of people with epilepsy both at rest and when asked to participate in physical activity with a self-selected intensity and bout duration. The study will collect information on the effect of the intervention on seizures, mood, quality of life, sleep, fitness, and heart-rate variability, as well as other epilepsy relevant outcomes.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older
• Focal or generalized epilepsy, as determined clinically by a WFBH epileptologist with no significant consideration of an alternative diagnosis
• Access to a smartphone with application capabilities
• Internet access or cellular data plan to attend virtual sessions
• Able to ambulate independently

Exclusion criteria

• Diagnosis of nonepileptic or psychogenic spells
• Seizures associated with falls with injury (such as atonic seizures)
• Medical conditions that would limit ability to participate in an exercise intervention including: Stage III or IV Congestive Heart Failure (CHF); End-stage Renal Disease; Severe dementia or significant cognitive impairment that precludes participation in the intervention or limits ability to follow the study protocol; Uncontrolled hypertension (HTN) defined as systolic blood pressure greater than 180 mmHg and diastolic blood pressure greater than 110 mmHg at rest; Severe arthritis, amputations, or orthopedic problems that limit ambulatory ability
• Currently pregnant or plan to become pregnant during the study period (16 weeks)
• An active Central Nervous System (CNS) infection, demyelinating disease, degenerative neurologic disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results
• Any clinically significant psychiatric illness, psychological, or behavioral problems that would interfere with the subject's ability to participate in the study.
• Unwilling or unable to comply with all study visits and procedures
• Participants who have <75% complete days of seizure recording in the study diary or step data via the Garmin device will not be randomized.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Arm 1: Physical Activity Intervention

Experimental group

Description:

Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.

Treatment:

Behavioral: 12-week Physical Activity Program

Arm 2: Control

No Intervention group

Description:

Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)