Steps for Epilepsy (StEpi)

A Feasibility Study of a Step-goal Based Physical Activity Intervention in People With Epilepsy

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: 12-week Physical Activity Program

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Physical Activity Intervention; 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.	Behavioral: 12-week Physical Activity Program; 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.
No Intervention: Arm 2: Control; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Who Achieve Their Assigned Step Goal - Adherence	As measured by average daily steps via the Garmin device over the last 4 weeks of the intervention period.	Week 12 to Week 16
Proportion of Participants Who Achieve Their Assigned Step Goal - Sustainability	As measured by average daily steps via the Garmin device over the last 4 weeks of the maintenance period, will be calculated and 95% binomial confidence intervals generated.	Week 24 to Week 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Spent Sedentary	Time spent sedentary during the last week of baseline as measured by the Garmin watch.	Week 4
Time Spent in Light Intensity Activity	Time spent in light intensity in the last week of baseline as measured by the Garmin watch.	Week 4
Time Spent in Moderate Intensity Activity	Time spent in moderate intensity in the last week of baseline as measured by the Garmin watch.	Week 4
Time Spent in Vigorous Intensity Activity	Time spent in vigorous intensity in the last week of baseline as measured by the Garmin watch.	Week 4
Exit Survey	The scale ranges from 4-20 with higher scores indicating greater satisfaction with the study.	Week 28
Exercise Satisfaction Survey- Proportion of Participants With a 4 or Higher Response	We will use the question "How satisfied were you with the exercise intervention?" with scale of 1-5, 1=VERY UNSATISFIED, 2=UNSATISFIED, 3=NEUTRAL, 4=SATISFIED, 5=VERY SATISFIED. Higher numbers denotes better outcomes. We will calculate the proportion of subjects who answer 4 or above.	Week 16
Time Spent Sedentary	Time spent sedentary during the last week of intervention as measured by the Garmin watch.	Week 16
Time Spent Sedentary	Time spent sedentary during the last week of maintenance as measured by the Garmin watch.	Week 28
Time Spent in Light Intensity Activity	Time spent in light intensity in the last week of intervention as measured by the Garmin watch.	Week 16
Time Spent in Light Intensity Activity	Time spent in light intensity in the last week of maintenance as measured by the Garmin watch.	Week 28
Time Spent in Moderate Intensity Activity	Time spent in moderate intensity in the last week of intervention as measured by the Garmin watch.	Week 16
Time Spent in Moderate Intensity Activity	Time spent in moderate intensity in the last week of maintenance as measured by the Garmin watch.	Week 28
Time Spent in Vigorous Intensity Activity	Time spent in vigorous intensity in the last week of intervention as measured by the Garmin watch.	Week 16
Time Spent in Vigorous Intensity Activity	Time spent in vigorous intensity in the last week of maintenance as measured by the Garmin watch.	Week 28

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Halley Alexander, MD, Wake Forest Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; step goal; tele health
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior; Epilepsy; Motor Activity
• Other Study ID Numbers: IRB00084252; UL1TR001420 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No