N/A N=21 Randomized Supportive Care

Steps for Epilepsy

Epilepsy

Bottom Line

View on ClinicalTrials.gov: NCT05359003 ↗

Enrolled (actual)

Serious AEs

23.8%

Results posted

Oct 2025

Primary outcome: Primary: Proportion of Participants Who Achieve Their Assigned Step Goal - Adherence — 0.267 Proportion

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 12-week Physical Activity Program (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Oct 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Participants Who Achieve Their Assigned Step Goal - Adherence	0.267	—
PRIMARY Proportion of Participants Who Achieve Their Assigned Step Goal - Sustainability	0.143	—
SECONDARY Time Spent Sedentary	4266; 5697	—
SECONDARY Time Spent in Light Intensity Activity	305; 742	—
SECONDARY Time Spent in Moderate Intensity Activity	179; 141	—
SECONDARY Time Spent in Vigorous Intensity Activity	57.3; 160	—
SECONDARY Exit Survey	18.43; 17.50	—
SECONDARY Exercise Satisfaction Survey- Proportion of Participants With a 4 or Higher Response	9	—
SECONDARY Time Spent Sedentary	4266; 5697	—
SECONDARY Time Spent Sedentary	4266; 5697	—
SECONDARY Time Spent in Light Intensity Activity	305; 742	—
SECONDARY Time Spent in Light Intensity Activity	305; 742	—
SECONDARY Time Spent in Moderate Intensity Activity	179; 141	—
SECONDARY Time Spent in Moderate Intensity Activity	179; 141	—
SECONDARY Time Spent in Vigorous Intensity Activity	57.3; 160	—
SECONDARY Time Spent in Vigorous Intensity Activity	57.3; 160	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05359003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.