Steps for Epilepsy (NCT05359003) | Clinical Trial Compass
CompletedNot Applicable
Steps for Epilepsy
United States26 participantsStarted 2023-02-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 p…
What they're measuring
1
Proportion of Participants Who Achieve Their Assigned Step Goal - Adherence
Timeframe: Week 12 to Week 16
2
Proportion of Participants Who Achieve Their Assigned Step Goal - Sustainability