Steps for Epilepsy

NCT05359003 | Completed Results DMC

• 2 other identifiers: IRB00084252UL1TR001420
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy

Keywords

physical activity; step goal; tele health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Time Spent Sedentary

  Week 4

• Time Spent in Light Intensity Activity

  Week 4

• Time Spent in Moderate Intensity Activity

  Week 4

• Time Spent in Vigorous Intensity Activity

  Week 4

• Exit Survey

  Week 28

Study Arms (2)

Arm 1: Physical Activity Intervention

EXPERIMENTAL

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

Arm 2: Control

NO INTERVENTION

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)

Interventions

12-week Physical Activity Program BEHAVIORAL

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.

Arm 1: Physical Activity Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Epilepsy; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Results Point of Contact

• Title: Halley Alexander, MD, MS, FACNS
• Organization: Wake Forest University School of Medicine

halley.alexander@advocatehealth.org

336-716-6898

Study Officials

• Halley Alexander, MD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, controlled trial with a two-arm, parallel group design with a healthy living education control

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 3, 2022
• Study Start: February 13, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 8, 2026
• Results First Posted: October 31, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)