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Steps for Epilepsy (StEpi)

Primary Purpose

Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
12-week physical activity program
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring physical activity, step goal, tele health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)
  • Current use of beta-blockers
  • 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.

Sites / Locations

  • Atrium Health Wake Forest BaptistRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm 1: Exercise Intervention

Arm 2 Control

Arm Description

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).

Participants randomized to the wait-list attention control group will continue to undergo standard care for 12 weeks.

Outcomes

Primary Outcome Measures

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.
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 intervention period, will be calculated and 95% binomial confidence intervals generated.

Secondary Outcome Measures

Time spent sedentary
Time spent in light intensity activity
Time spent in moderate intensity activity
Time spent in vigorous intensity activity
Exit survey
The scale ranges from 4-20 with higher scores indicating greater satisfaction with the study.
Exercise Satisfaction Survey- Proportion of participants with a 4 or higher response
We will use the question "How satisfied were you with the exercise intervention?" with scale of 1-5, 1=VERY UNSATISFIED, 2=UNSATISFIED, 3=NEUTRAL, 4=SATISFIED, 5=VERY SATISFIED. Higher numbers denotes better outcomes. We will calculate the proportion of subjects who answer 4 or above.

Full Information

First Posted
April 28, 2022
Last Updated
March 28, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05359003
Brief Title
Steps for Epilepsy
Acronym
StEpi
Official Title
A Feasibility Study of a Step-goal Based Physical Activity Intervention in People With Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
physical activity, step goal, tele health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, controlled trial with a two-arm, parallel group design with a wait-list education
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Exercise Intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Arm 2 Control
Arm Type
No Intervention
Arm Description
Participants randomized to the wait-list attention control group will continue to undergo standard care for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
12-week physical activity program
Intervention Description
Program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.
Primary Outcome Measure Information:
Title
Proportion of participants who achieve their assigned step goal - adherence
Description
As measured by average daily steps via the Garmin device over the last 4 weeks of the intervention period.
Time Frame
Week 12 to Week 14
Title
Proportion of participants who achieve their assigned step goal- sustainability
Description
As measured by average daily steps via the Garmin device over the last 4 weeks of the intervention period, will be calculated and 95% binomial confidence intervals generated.
Time Frame
Week 24 to Week 28
Secondary Outcome Measure Information:
Title
Time spent sedentary
Time Frame
Week 4, Week 16, and Week 28
Title
Time spent in light intensity activity
Time Frame
Week 4, Week 16, and Week 28
Title
Time spent in moderate intensity activity
Time Frame
Week 4, Week 16, and Week 28
Title
Time spent in vigorous intensity activity
Time Frame
Week 4, Week 16, and Week 28
Title
Exit survey
Description
The scale ranges from 4-20 with higher scores indicating greater satisfaction with the study.
Time Frame
Week 28
Title
Exercise Satisfaction Survey- Proportion of participants with a 4 or higher response
Description
We will use the question "How satisfied were you with the exercise intervention?" with scale of 1-5, 1=VERY UNSATISFIED, 2=UNSATISFIED, 3=NEUTRAL, 4=SATISFIED, 5=VERY SATISFIED. Higher numbers denotes better outcomes. We will calculate the proportion of subjects who answer 4 or above.
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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) Current use of beta-blockers 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HALLEY ALEXANDER, MD
Phone
336-716-6898
Email
HALEXAND@WAKEHEALTH.EDU
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halley Alexander, MD
Organizational Affiliation
Wake Forest Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health Wake Forest Baptist
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halley B Alexander, MD
Phone
336-716-6898
Email
halexand@wakehealth.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Steps for Epilepsy

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