Clinical trial NCT04607317: Exercise as Adjunctive Treatment for Refractory Epilepsy
Official title: A Telehealth Physical Exercise Intervention for the Treatment of Drug Resistant Epilepsy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Refractory Epilepsy
Epilepsy
Keywords: exercise
telehealth
adjunctive treatment
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to exercise intervention arm or control arm.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a randomized, controlled pilot trial to assess the feasibility and fidelity of a 12 week, individualized, telehealth exercise intervention in people with refractory epilepsy. This will be carried out using a 2 arm, parallel group design with a waitlist attention control.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants recruited
timeFrame: Week 0 Baseline
measure: Proportion of participants completing all visits
timeFrame: Visit 3 (Week 16 after Baseline)
Secondary outcomes:
measure: Proportion of Participants who achieve their target
timeFrame: Visit 3 (Week 16 after Baseline)
measure: Acceptability of the Intervention Questionnaire
timeFrame: Week 16 and Week 28 after baseline
measure: Percentage of participants achieving the goal for at least 10 weeks
timeFrame: Week 28 after baseline
Other outcomes:
measure: Heart Rate Variability (HRV) measurement
timeFrame: baseline and Visit 3 (week 16 after baseline)
measure: Perceived Stress Scale (PSS)
timeFrame: baseline, week 16 after baseline, week 28 after baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline, week 16 after baseline, week 28 after baseline
measure: Nightly average total sleep time (TST)
timeFrame: baseline, week 16 after baseline, week 28 after baseline
measure: Change in Seizure Frequency
timeFrame: baseline, week 16 after baseline, week 28 after baseline
measure: Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
timeFrame: baseline, Visit 3 (week 16 after baseline)
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: baseline, week 16 after baseline, week 28 after baseline
measure: Test of Premorbid Functioning (TOPF)
timeFrame: baseline
measure: Wechsler Adult Intelligence Scale - 4th edition (WAIS-IV)
timeFrame: baseline and week 16 after baseline
measure: Controlled Oral Word Association Test (COWAT)
timeFrame: baseline and week 16 after baseline
measure: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: baseline and week 16 after baseline
measure: Delis-Kaplan Executive Function Stroop Test
timeFrame: baseline and week 16 after baseline
measure: Physical Function: walk test
timeFrame: baseline and week 16 after baseline
measure: Quality of Life in Epilepsy-31 (QOLIE-31)
timeFrame: baseline, week 16 after baseline, week 28 after baseline
measure: Exercise Self-Efficacy Questionnaire (EXSE)
timeFrame: baseline, week 16 after baseline, week 28 after baseline
measure: Exercise Goal Setting Questionnaire (EGS)
timeFrame: baseline, week 16 after baseline, week 28 after baseline
measure: Multidimensional Expectations for Exercise Scale (MOEES) Physical Score
timeFrame: baseline, week 16 after baseline, week 28 after baseline
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Halley Alexander, MD
role: PRINCIPAL_INVESTIGATOR
References: