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Physical Activity Program for Epilepsy (StEpi Trial)

N/A
Waitlist Available
Led By Halley Alexander, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4, week 16, and week 28
Awards & highlights

StEpi Trial Summary

This trial will study whether a 12-week, goal-based physical activity intervention delivered over telehealth is feasible for people with epilepsy, as well as its effects on physical activity levels, epilepsy, and epilepsy-related comorbidities.

Who is the study for?
This trial is for adults with epilepsy who can walk on their own and have a smartphone with internet access. They must not be at risk of injury from seizures, taking beta-blockers, or planning pregnancy during the study. People with severe psychiatric issues, certain medical conditions like advanced heart failure or uncontrolled high blood pressure, or cognitive impairments that prevent following instructions are excluded.Check my eligibility
What is being tested?
The 'Steps for Epilepsy' trial tests a 12-week physical activity program delivered via telehealth to see if it's doable for people with epilepsy. It also looks into how this intervention affects their overall physical activity and any related health issues.See study design
What are the potential side effects?
Since the intervention involves increased physical activity through a step-goal program, potential side effects may include typical exercise-related discomforts such as muscle soreness or fatigue. However, specific risks will depend on each participant's individual health condition.

StEpi Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4, week 16, and week 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4, week 16, and week 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants who achieve their assigned step goal - adherence
Proportion of participants who achieve their assigned step goal- sustainability
Secondary outcome measures
Exercise Satisfaction Survey- Proportion of participants with a 4 or higher response
Exit survey
Time spent in light intensity activity
+3 more

StEpi Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Exercise InterventionExperimental Treatment1 Intervention
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).
Group II: Arm 2 ControlActive Control1 Intervention
Participants randomized to the wait-list attention control group will continue to undergo standard care for 12 weeks.

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,157 Total Patients Enrolled
9 Trials studying Epilepsy
1,319 Patients Enrolled for Epilepsy
Halley Alexander, MDPrincipal InvestigatorWake Forest Health Sciences
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Epilepsy
10 Patients Enrolled for Epilepsy

Media Library

12-week physical activity program Clinical Trial Eligibility Overview. Trial Name: NCT05359003 — N/A
12-week physical activity program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05359003 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is admission to this medical experiment still available?

"Clinicaltrials.gov notes that this medical study, having been initially posted on January 1st 2023 and most recently amended on November 28th 2022, is not recruiting patients presently. However 239 other trials are actively looking for participants right now."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Steps for Epilepsy
2023. "Steps for Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05359003.
All > Lgs Foundation > Epilepsy
~6 spots leftby Sep 2024
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