Exercise as Adjunctive Treatment for Refractory Epilepsy
NCT ID: NCT04607317
Last Updated: 2022-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2021-04-13
2022-05-31
Brief Summary
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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.
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Detailed Description
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Participants will undergo formal exercise testing prior to enrollment to determine safety and establish a baseline fitness level. Participants will use a wrist-worn Garmin device to record activity and sleep. After a 4 week baseline period, participants will be randomized to intervention or wait-list attention control. The intervention group will undergo a 12-week telehealth exercise program designed by a trained health coach and tailored to the individual's personal fitness level and exercise preferences. The intervention is based in social cognitive theory to implement and enforce sustainable behavior change. The wait-list attention control will receive health education but will not be given an exercise program. At the end of the intervention period, the control group will be given the option to participate in the exercise program.
The study will assess recruitment and retention as well as fidelity, acceptability and sustainability of a telehealth exercise intervention in this population.
The study will investigate objective and subjective measures of the effect of the intervention on the known seizure triggers of sleep and stress as possible mediators of seizure frequency.
The study will collect information regarding the effects of the intervention on depression, anxiety, quality of life, cognition, and seizure frequency.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Blinded study staff will perform all pre-and post outcome assessments. The PI will also be blinded
Study Groups
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Exercise Intervention
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.
Exercise program
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)
Health Coach
The coach will work directly with each participant during their once-weekly virtual 1:1 meeting to progress intensity and duration. Participants will meet with the coach to review a brief social cognitive theory-based module, which will provide education on core behavior change concepts and the benefits of physical activity for those with epilepsy. The coach will review the previous week's exercise during meetings, and will then work with the participant to revise and reset goals for the coming week.
Control
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.
Health Information
Participants 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.
Interventions
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Exercise program
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)
Health Coach
The coach will work directly with each participant during their once-weekly virtual 1:1 meeting to progress intensity and duration. Participants will meet with the coach to review a brief social cognitive theory-based module, which will provide education on core behavior change concepts and the benefits of physical activity for those with epilepsy. The coach will review the previous week's exercise during meetings, and will then work with the participant to revise and reset goals for the coming week.
Health Information
Participants 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Halley Alexander, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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IRB00068408
Identifier Type: -
Identifier Source: org_study_id
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