Clinical trial NCT05359003: Steps for Epilepsy
Official title: A Feasibility Study of a Step-goal Based Physical Activity Intervention in People With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: physical activity
step goal
tele health
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-05-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, controlled trial with a two-arm, parallel group design with a wait-list education
Primary purpose: SUPPORTIVE_CARE

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.

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 wait list attention 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 of a wait-list 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. At the end of the intervention period, the control group will have the option to participate in the intervention while the intervention group will be evaluated for another 12 weeks to assess sustainability. The study will evaluate adherence to the intervention 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.

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.

Primary outcomes:
measure: Proportion of participants who achieve their assigned step goal - adherence
timeFrame: Week 12 to Week 14
measure: Proportion of participants who achieve their assigned step goal- sustainability
timeFrame: Week 24 to Week 28
Secondary outcomes:
measure: Time spent sedentary
timeFrame: Week 4, Week 16, and Week 28
measure: Time spent in light intensity activity
timeFrame: Week 4, Week 16, and Week 28
measure: Time spent in moderate intensity activity
timeFrame: Week 4, Week 16, and Week 28
measure: Time spent in vigorous intensity activity
timeFrame: Week 4, Week 16, and Week 28
measure: Exit survey
timeFrame: Week 28
measure: Exercise Satisfaction Survey- Proportion of participants with a 4 or higher response
timeFrame: Week 16
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: Halley Alexander, MD
role: PRINCIPAL_INVESTIGATOR
References: