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Exercise as Adjunctive Treatment for Refractory Epilepsy

Primary Purpose

Refractory Epilepsy, Epilepsy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise program
Health Coach
Health Information
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Epilepsy focused on measuring exercise, telehealth, adjunctive treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of participants recruited
This outcome measure assesses Feasibility of Recruitment. Recruitment will be calculated as a percentage by dividing the total number of enrolled participants by the total number of eligible participants.
Proportion of participants completing all visits
This outcome measure assesses Feasibility of Retention. Retention will be calculated as the percentage of all participants who complete Visit 2 Week 16 (End of Intervention) out of the total number of participants enrolled.

Secondary Outcome Measures

Proportion of Participants who achieve their target
Fidelity of the Intervention is the proportion of participants in the intervention group who achieve their target HR for at least 80% of their individually prescribed weekly minutes. A priori goal 70% of participants achieve this in at least 10 out of the 12 weeks of the intervention
Acceptability of the Intervention Questionnaire
This will be a qualitative measure based on post program question of how satisfied the subject was with the exercise intervention with a scale of 1=Very Unsatisfied, 2=Unsatisfied, 3=Neutral, 4=Satisfied, 5=Very Satisfied. Results will include percentage of people who answer 4 or above.
Percentage of participants achieving the goal for at least 10 weeks
Sustainability of the intervention is defined as maintenance of at least 80% of the last assigned weekly minutes in target HR zone each week. The intervention will be considered sustainable if 60% of the participants achieve this goal for at least 10 out of the 12 follow-up weeks.

Full Information

First Posted
October 23, 2020
Last Updated
December 4, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04607317
Brief Title
Exercise as Adjunctive Treatment for Refractory Epilepsy
Official Title
A Telehealth Physical Exercise Intervention for the Treatment of Drug Resistant Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
did not enroll as many as planned
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Epilepsy, Epilepsy
Keywords
exercise, telehealth, adjunctive treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to exercise intervention arm or control arm.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
Due to the nature of the intervention, participants will not be blinded as to whether they are in the intervention or control group. Blinded study staff will perform all pre-and post outcome assessments. The PI will also be blinded
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise program
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Health Coach
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Information
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of participants recruited
Description
This outcome measure assesses Feasibility of Recruitment. Recruitment will be calculated as a percentage by dividing the total number of enrolled participants by the total number of eligible participants.
Time Frame
Week 0 Baseline
Title
Proportion of participants completing all visits
Description
This outcome measure assesses Feasibility of Retention. Retention will be calculated as the percentage of all participants who complete Visit 2 Week 16 (End of Intervention) out of the total number of participants enrolled.
Time Frame
Visit 3 (Week 16 after Baseline)
Secondary Outcome Measure Information:
Title
Proportion of Participants who achieve their target
Description
Fidelity of the Intervention is the proportion of participants in the intervention group who achieve their target HR for at least 80% of their individually prescribed weekly minutes. A priori goal 70% of participants achieve this in at least 10 out of the 12 weeks of the intervention
Time Frame
Visit 3 (Week 16 after Baseline)
Title
Acceptability of the Intervention Questionnaire
Description
This will be a qualitative measure based on post program question of how satisfied the subject was with the exercise intervention with a scale of 1=Very Unsatisfied, 2=Unsatisfied, 3=Neutral, 4=Satisfied, 5=Very Satisfied. Results will include percentage of people who answer 4 or above.
Time Frame
Week 16 and Week 28 after baseline
Title
Percentage of participants achieving the goal for at least 10 weeks
Description
Sustainability of the intervention is defined as maintenance of at least 80% of the last assigned weekly minutes in target HR zone each week. The intervention will be considered sustainable if 60% of the participants achieve this goal for at least 10 out of the 12 follow-up weeks.
Time Frame
Week 28 after baseline
Other Pre-specified Outcome Measures:
Title
Heart Rate Variability (HRV) measurement
Description
Continuous heart rate will be recorded while the participant is breathing normally in seated position for 10 minutes. This will be assessed by sympathetic and parasympathetic activity expressed as low-frequency (LF) and high-frequency (HF) power spectrum, standard deviation of NN intervals (SDNN), and the root mean square of successive differences (RMSSD).
Time Frame
baseline and Visit 3 (week 16 after baseline)
Title
Perceived Stress Scale (PSS)
Description
A validated measure of the subjective stress experience which has been shown to correlate with systemic stress hormones. Individual scores can range from 0 to 40 with higher score indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress.
Time Frame
baseline, week 16 after baseline, week 28 after baseline
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Scores range from 0-21 with higher score indicating worse sleep quality. A common cutoff for poor sleep quality is score greater than 5.
Time Frame
baseline, week 16 after baseline, week 28 after baseline
Title
Nightly average total sleep time (TST)
Description
will be collected from the wearable device
Time Frame
baseline, week 16 after baseline, week 28 after baseline
Title
Change in Seizure Frequency
Description
the number of seizures during the final 4 weeks of the intervention will be compared to the number of seizures during the 4 week baseline.
Time Frame
baseline, week 16 after baseline, week 28 after baseline
Title
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
Description
Scores range from 6-24 with higher scores indicating higher risk for depression. A common cutoff is that a score greater than 15 is suggestive of major depression.
Time Frame
baseline, Visit 3 (week 16 after baseline)
Title
Generalized Anxiety Disorder (GAD-7)
Description
Scores range from 0-21. A score of 10 or greater suggests high risk for Generalized Anxiety Disorder (GAD), while scores of 5-9, 10-14, and 15-21 could represent mild, moderate, and severe GAD.
Time Frame
baseline, week 16 after baseline, week 28 after baseline
Title
Test of Premorbid Functioning (TOPF)
Description
TOPF is a test of static cognitive function. This is a standard score with a mean of 100 and a standard deviation of 15. The score can range from ~60-145. This is a single word reading test that is used to estimate premorbid functioning. A higher score denotes a better outcome.
Time Frame
baseline
Title
Wechsler Adult Intelligence Scale - 4th edition (WAIS-IV)
Description
Digit Span Subtest. A common measure of current overall intellectual functioning. This scale produces a standard score with a mean of 100 and a standard deviation of 15. A higher score is better.
Time Frame
baseline and week 16 after baseline
Title
Controlled Oral Word Association Test (COWAT)
Description
This test produces a T score with a mean of 50 and an standard deviation of 10. It measures lexical and semantic verbal fluency.
Time Frame
baseline and week 16 after baseline
Title
Rey Auditory Verbal Learning Test (RAVLT)
Description
This test produces a T score with a mean of 50 and a standard deviation of 10. It measures verbal learning and memory.
Time Frame
baseline and week 16 after baseline
Title
Delis-Kaplan Executive Function Stroop Test
Description
This test produces a scaled score of 10 with a standard deviation of 3. It measures cognitive inhibition.
Time Frame
baseline and week 16 after baseline
Title
Physical Function: walk test
Description
Measure of cardiorespiratory fitness. Distance walked in 6 minutes.
Time Frame
baseline and week 16 after baseline
Title
Quality of Life in Epilepsy-31 (QOLIE-31)
Description
Score ranges from 0-100 with higher score indicating better quality of life.
Time Frame
baseline, week 16 after baseline, week 28 after baseline
Title
Exercise Self-Efficacy Questionnaire (EXSE)
Description
Items on all self-efficacy questionnaire that ask participants to rate their confidence on a 100-point percentage scale such that 0% corresponds with "not confident at all", and 100% corresponds with "highly confident", and scale scores are generated by averaging all items in the scale. Higher scores represent greater self-efficacy.
Time Frame
baseline, week 16 after baseline, week 28 after baseline
Title
Exercise Goal Setting Questionnaire (EGS)
Description
This questionnaire assesses participants' ability to set and meet goals relative to exercise behavior by asking how closely a series of statements describes them (e.g., "I usually set dates for achieving my goals") on a 5 point scale such that 1 corresponds with "Does not Describe" and 5 corresponds with "Describes Completely". A total scale score was generated by summing all items, with possible scores ranging from 10 to 50 with higher scores reflecting greater goal setting behavior
Time Frame
baseline, week 16 after baseline, week 28 after baseline
Title
Multidimensional Expectations for Exercise Scale (MOEES) Physical Score
Description
This 15-item questionnaire assesses the three dimensions of outcome expectations for exercise (i.e., physical, social, and self-evaluative). Participants are asked to rate the degree to which they agree with statements relating to outcome expectations (e.g., "Exercise will increase my muscle strength") on a 5-point scale. Three subscale scores will be generated. Physical scores range from 6 to 30 with higher scores indicating higher levels of outcome expectations for exercise.
Time Frame
baseline, week 16 after baseline, week 28 after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halley Alexander, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise as Adjunctive Treatment for Refractory Epilepsy

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