TerminatedNot Applicable

Exercise as Adjunctive Treatment for Refractory Epilepsy

Stopped: did not enroll as many as planned

United States10 participantsStarted 2021-04-13

Plain-language summary

The purpose of this research study is to determine whether a 12-week telehealth aerobic exercise intervention is feasible in people with epilepsy. The study team will also gather information on the effect of the intervention on sleep and stress as mediators of seizure frequency, well as effects on epilepsy and epilepsy associated comorbidities.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 or older * Focal or generalized epilepsy, as clinically determined by a Wake Forest Baptist Health epileptologist. * Seizure frequency of at least 1 clinically observable seizure in the year prior to enrollment * Able to ambulate independently without assistive device * Access to a smartphone with application capabilities * Internet access or cellular data plan to attend virtual sessions Exclusion Criteria: * Diagnosis of nonepileptic or psychogenic spells * Seizures associated with frequent falls with injury * \<50% adherence with wearing the device or completing the study diary during the baseline period. * Currently in an exercise program * Medical conditions that would limit ability to participate in an exercise intervention such as: * Stage III or IV Congestive Heart Failure (CHF) * End-stage Renal Disease * Severe dementia or significant cognitive impairment * Uncontrolled hypertension (HTN) * Motor conditions that limit ambulation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of participants recruited

Timeframe: Week 0 Baseline

Proportion of participants completing all visits

Timeframe: Visit 3 (Week 16 after Baseline)

Trial details

NCT IDNCT04607317

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-31

View on ClinicalTrials.gov More Refractory Epilepsy trials