Exercise as Adjunctive Treatment for Refractory Epilepsy

Epilepsy Clinical Trial

Official title:

A Telehealth Physical Exercise Intervention for the Treatment of Drug Resistant Epilepsy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04607317
• Other study ID #: IRB00068408
• Status: Terminated
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: February 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart Rate Variability (HRV) measurement	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).	baseline and Visit 3 (week 16 after baseline)
Other	Perceived Stress Scale (PSS)	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.	baseline, week 16 after baseline, week 28 after baseline
Other	Pittsburgh Sleep Quality Index (PSQI)	Scores range from 0-21 with higher score indicating worse sleep quality. A common cutoff for poor sleep quality is score greater than 5.	baseline, week 16 after baseline, week 28 after baseline
Other	Nightly average total sleep time (TST)	will be collected from the wearable device	baseline, week 16 after baseline, week 28 after baseline
Other	Change in Seizure Frequency	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.	baseline, week 16 after baseline, week 28 after baseline
Other	Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)	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.	baseline, Visit 3 (week 16 after baseline)
Other	Generalized Anxiety Disorder (GAD-7)	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.	baseline, week 16 after baseline, week 28 after baseline
Other	Test of Premorbid Functioning (TOPF)	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.	baseline
Other	Wechsler Adult Intelligence Scale - 4th edition (WAIS-IV)	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.	baseline and week 16 after baseline
Other	Controlled Oral Word Association Test (COWAT)	This test produces a T score with a mean of 50 and an standard deviation of 10. It measures lexical and semantic verbal fluency.	baseline and week 16 after baseline
Other	Rey Auditory Verbal Learning Test (RAVLT)	This test produces a T score with a mean of 50 and a standard deviation of 10. It measures verbal learning and memory.	baseline and week 16 after baseline
Other	Delis-Kaplan Executive Function Stroop Test	This test produces a scaled score of 10 with a standard deviation of 3. It measures cognitive inhibition.	baseline and week 16 after baseline
Other	Physical Function: walk test	Measure of cardiorespiratory fitness. Distance walked in 6 minutes.	baseline and week 16 after baseline
Other	Quality of Life in Epilepsy-31 (QOLIE-31)	Score ranges from 0-100 with higher score indicating better quality of life.	baseline, week 16 after baseline, week 28 after baseline
Other	Exercise Self-Efficacy Questionnaire (EXSE)	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.	baseline, week 16 after baseline, week 28 after baseline
Other	Exercise Goal Setting Questionnaire (EGS)	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	baseline, week 16 after baseline, week 28 after baseline
Other	Multidimensional Expectations for Exercise Scale (MOEES) Physical Score	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.	baseline, week 16 after baseline, week 28 after baseline
Primary	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.	Week 0 Baseline
Primary	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.	Visit 3 (Week 16 after Baseline)
Secondary	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	Visit 3 (Week 16 after Baseline)
Secondary	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.	Week 16 and Week 28 after baseline
Secondary	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.	Week 28 after baseline