Status:
COMPLETED
Steps for Epilepsy
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Epilepsy
Eligibility:
All Genders
18+ years
Phase:
NA
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 e...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05359003
Start Date
February 13 2023
End Date
October 1 2024
Last Update
January 8 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157