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Exercise program for Epilepsy

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
Age 18 or older
Focal or generalized epilepsy, as clinically determined by a Wake Forest Baptist Health epileptologist.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study Summary

This trial will test whether a 12-week program of aerobic exercise, delivered via telehealth, can help people with epilepsy manage their condition.

Eligible Conditions
  • Epilepsy

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16 and week 28 after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 and week 28 after baseline 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 completing all visits
Proportion of participants recruited
Secondary outcome measures
Acceptability of the Intervention Questionnaire
Percentage of participants achieving the goal for at least 10 weeks
Proportion of Participants who achieve their target
Other outcome measures
Change in Seizure Frequency
Controlled Oral Word Association Test (COWAT)
Delis-Kaplan Executive Function Stroop Test
+14 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise InterventionExperimental Treatment2 Interventions
Participants in this arm will be enrolled in a telehealth-delivered exercise program with the goal of progressing to 150 min/week (5 days per week, 30 minutes of steady state walking per day). Participants will meet weekly 1:1 with a trained health coach via a Webex platform. Weekly exercise goals will be tailored to the individual's abilities and specific barriers. Coaching will utilize social cognitive theory and self-determination theory to develop self-efficacy for sustainable behavior change.
Group II: ControlActive Control1 Intervention
Participants randomized to the wait-list attention control group will continue to undergo standard care for 12 weeks. They will continue to wear the Garmin activity tracker and can view their activity but will not be given an exercise program. They will be contacted by a study coordinator via telephone every 2 weeks for health education. During this time, they will review resources and healthy lifestyle guidelines for people with epilepsy, including healthy diet, medication compliance, seizure precautions, stress management, and sleep hygiene.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise program
2016
Completed Phase 4
~1390
Health Coach
2014
N/A
~160

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,197 Total Patients Enrolled
9 Trials studying Epilepsy
1,335 Patients Enrolled for Epilepsy
Halley Alexander, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
26 Total Patients Enrolled
1 Trials studying Epilepsy
26 Patients Enrolled for Epilepsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Exercise as Adjunctive Treatment for Refractory Epilepsy
2021. "Exercise as Adjunctive Treatment for Refractory Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04607317.
~2 spots leftby Apr 2025
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