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EpilepsyStEpiNCT05359003

Steps for Epilepsy

A study testing 12-week Physical Activity Program in people with Epilepsy, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Epilepsy
What is being tested?
12-week Physical Activity Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
13 Feb 2023to 1 Oct 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Feasibility Study of a Step-goal Based Physical Activity Intervention in People With Epilepsy

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.

Read the 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 healthy living education 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 or a healthy living education 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. The study will evaluate adherence to the intervention, sustainability of the intervention over 12 weeks 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.

Conditions
Epilepsy
Being tested
12-week Physical Activity Program
Keywords
physical activity, step goal, tele health
Medical subject headings
Epilepsy, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 12-week Physical Activity ProgramBehavioural

    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). Includes weekly meetings with a trained health coach.

Study groups in NCT05359003
Study groupRoleWhat they receive
Arm 1: Physical Activity InterventionExperimentalParticipants 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). Includes weekly meetings with a trained health coach.
Receives: Behavioral: 12-week Physical Activity Program
Arm 2: ControlNo interventionParticipants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 12 to Week 16

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

    Measured: Week 24 to Week 28

Secondary outcomes (14)

  1. Time Spent Sedentary

    Time spent sedentary during the last week of baseline as measured by the Garmin watch.

    Measured: Week 4

  2. Time Spent in Light Intensity Activity

    Time spent in light intensity in the last week of baseline as measured by the Garmin watch.

    Measured: Week 4

  3. Time Spent in Moderate Intensity Activity

    Time spent in moderate intensity in the last week of baseline as measured by the Garmin watch.

    Measured: Week 4

  4. Time Spent in Vigorous Intensity Activity

    Time spent in vigorous intensity in the last week of baseline as measured by the Garmin watch.

    Measured: Week 4

  5. Exit Survey

    The scale ranges from 4-20 with higher scores indicating greater satisfaction with the study.

    Measured: Week 28

  6. 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.

    Measured: Week 16

  7. Time Spent Sedentary

    Time spent sedentary during the last week of intervention as measured by the Garmin watch.

    Measured: Week 16

  8. Time Spent Sedentary

    Time spent sedentary during the last week of maintenance as measured by the Garmin watch.

    Measured: Week 28

  9. Time Spent in Light Intensity Activity

    Time spent in light intensity in the last week of intervention as measured by the Garmin watch.

    Measured: Week 16

  10. Time Spent in Light Intensity Activity

    Time spent in light intensity in the last week of maintenance as measured by the Garmin watch.

    Measured: Week 28

  11. Time Spent in Moderate Intensity Activity

    Time spent in moderate intensity in the last week of intervention as measured by the Garmin watch.

    Measured: Week 16

  12. Time Spent in Moderate Intensity Activity

    Time spent in moderate intensity in the last week of maintenance as measured by the Garmin watch.

    Measured: Week 28

  13. Time Spent in Vigorous Intensity Activity

    Time spent in vigorous intensity in the last week of intervention as measured by the Garmin watch.

    Measured: Week 16

  14. Time Spent in Vigorous Intensity Activity

    Time spent in vigorous intensity in the last week of maintenance as measured by the Garmin watch.

    Measured: Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2022
  2. Study start13 Feb 2023
  3. Primary completion1 Oct 2024
  4. Study completion1 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized, controlled trial with a two-arm, parallel group design with a healthy living education control
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05359003
Sponsor's protocol ID
IRB00084252
Other IDs
UL1TR001420
Acronym
StEpi
Status last verified
Mar 2024
First submitted
28 Apr 2022
Last updated
8 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 12-week Physical Activity Program in people with Epilepsy, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Who Achieve Their Assigned Step Goal - Adherence (time frame: Week 12 to Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05359003.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.

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Steps for Epilepsy (NCT05359003) | AzTrials