Steps for Epilepsy

Epilepsy Clinical Trial

— StEpi  

Official title:

A Feasibility Study of a Step-goal Based Physical Activity Intervention in People With Epilepsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05359003
• Other study ID #: IRB00084252
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• 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 evaluate the feasibility of a 12-week, telehealth delivered, step-goal based physical activity intervention in people with epilepsy. The study team will also evaluate the physical activity profiles of people with epilepsy both at rest and when engaged in physical activity and gather information on the effect of the intervention on epilepsy and epilepsy associated comorbidities.

Description:

This is a randomized, controlled, pilot trial to assess the feasibility of a 12-week telehealth delivered, step-goal based physical activity intervention in people with epilepsy. This will be carried out using a 2-arm, parallel group design with a wait list attention control. Participants will undergo formal exercise testing to establish a baseline fitness level and safety of participation. They will wear Garmin activity tracker on their wrist throughout the study to track their steps. During a 4 week baseline period, we will gather data on baseline physical activity levels and seizure frequency. Participants will then be randomized to either the intervention group of a wait-list control group. The intervention group will undergo a 12-week, telehealth delivered, step goal based physical activity intervention with a goal of ultimately achieving at least 8,000 steps per day. The intervention will utilize social cognitive theory to encourage lasting behavior changes and have weekly group coaching sessions with a trained health and behavior change provider. The control group will receive education every two weeks but will not be given a coaching plan. At the end of the intervention period, the control group will have the option to participate in the intervention while the intervention group will be evaluated for another 12 weeks to assess sustainability. The study will evaluate adherence to the intervention after the formal coaching program ends, and acceptability of the intervention. The study will also investigate the physical activity profile of people with epilepsy both at rest and when asked to participate in physical activity with a self-selected intensity and bout duration. the study will collect information on the effect of the intervention on seizures, mood, quality of life, sleep, fitness, and heart-rate variability, as well as other epilepsy relevant outcomes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Focal or generalized epilepsy, as determined clinically by a WFBH epileptologist with no significant consideration of an alternative diagnosis

• Access to a smartphone with application capabilities

• Internet access or cellular data plan to attend virtual sessions

• Able to ambulate independently

Exclusion Criteria:

• Diagnosis of nonepileptic or psychogenic spells

• Seizures associated with falls with injury (such as atonic seizures)

• Medical conditions that would limit ability to participate in an exercise intervention including:

Stage III or IV Congestive Heart Failure (CHF) End-stage Renal Disease Severe dementia or significant cognitive impairment that precludes participation in the intervention or limits ability to follow the study protocol Uncontrolled hypertension (HTN) defined as systolic blood pressure greater than 180 mmHg and diastolic blood pressure greater than 110 mmHg at rest Severe arthritis, amputations, or orthopedic problems that limit ambulatory ability

• Currently pregnant or plan to become pregnant during the study period (16 weeks)

• An active Central Nervous System (CNS) infection, demyelinating disease, degenerative neurologic disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results

• Any clinically significant psychiatric illness, psychological, or behavioral problems that would interfere with the subject's ability to participate in the study.

• Unwilling or unable to comply with all study visits and procedures

• Participants who have <75% complete days of seizure recording in the study diary or step data via the Garmin device will not be randomized.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• 12-week physical activity program
Program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist	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
Primary	Proportion of participants who achieve their assigned step goal - adherence	As measured by average daily steps via the Garmin device over the last 4 weeks of the intervention period.	Week 12 to Week 14
Primary	Proportion of participants who achieve their assigned step goal- sustainability	As measured by average daily steps via the Garmin device over the last 4 weeks of the intervention period, will be calculated and 95% binomial confidence intervals generated.	Week 24 to Week 28
Secondary	Time spent sedentary		Week 4, Week 16, and Week 28
Secondary	Time spent in light intensity activity		Week 4, Week 16, and Week 28
Secondary	Time spent in moderate intensity activity		Week 4, Week 16, and Week 28
Secondary	Time spent in vigorous intensity activity		Week 4, Week 16, and Week 28
Secondary	Exit survey	The scale ranges from 4-20 with higher scores indicating greater satisfaction with the study.	Week 28
Secondary	Exercise Satisfaction Survey- Proportion of participants with a 4 or higher response	We will use the question "How satisfied were you with the exercise intervention?" with scale of 1-5, 1=VERY UNSATISFIED, 2=UNSATISFIED, 3=NEUTRAL, 4=SATISFIED, 5=VERY SATISFIED. Higher numbers denotes better outcomes. We will calculate the proportion of subjects who answer 4 or above.	Week 16