Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?

The purpose of this study is to evaluate standard of care exercise education alone or in combination with a wearable physical activity tracker in people with epilepsy (PWE) to determine the most effective way to increase physical activity and measure impact on depression, anxiety, quality of life, sleep, and seizure frequency.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Activity Tracker Group; Behavioral: Standard of Care Group

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patient of the Texas Comprehensive Epilepsy Program at UTHealth-McGovern Medical School
• diagnosis of epilepsy
• be able to provide consent in English
• complete surveys independently
• be able to sync Fitbit data

Exclusion Criteria:

• currently using a wearable physical activity tracker prior to enrollment
• pregnant or planning to become pregnant during the study duration
• planning to undergo epilepsy surgery during the study duration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Behavioral: Activity Tracker Group; In addition to the standard of care exercise education, participants in the activity tracker group will be provided a Fitbit physical activity tracker at no cost to the participants. They will be asked to download the Fitbit application (app) to their personal smartphone device to allow them to see their own data collected by the Fitbit. They will also be asked to download the Stridekick app for the purpose of sharing their activity tracker data electronically with the study team and having the opportunity to participate in fitness challenges through the app. App accounts will be created by the participants with usernames that do not contain the participant's identifiable personal information. Optional fitness challenges will be created once per month by the study investigators, and participants will also receive a weekly message of encouragement from the study team.
Active Comparator: Control Group	Behavioral: Standard of Care Group; Participants will receive standard of care exercise education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of steps taken by participant		3 months after enrollment
Total distance traveled by participant		3 months after enrollment
Total time participant is active	measured in minutes	3 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression as measured by the Patient Health Questionnaire depression scale (PHQ-9)	this is scored form 0-27 with a higher number indicating higher severity	Baseline
Depression as measured by the Patient Health Questionnaire depression scale (PHQ-9)	this is scored form 0-27 with a higher number indicating higher severity	end of study (3 months after enrollment)
Anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7)	The GAD-7 score ranges form 0 (minimal anxiety) to 21 (severe anxiety)	Baseline
Anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7)	The GAD-7 score ranges form 0 (minimal anxiety) to 21 (severe anxiety)	end of study (3 months after enrollment)
Sleep as measures by the Epworth Sleepiness Scale (ESS)	The ESS scale ranges form 0 (would never dose) to 3 (high chance of dozing)	Baseline
Sleep as measures by the Epworth Sleepiness Scale (ESS)	The ESS scale ranges form 0 (would never dose) to 3 (high chance of dozing)	end of study (3 months after enrollment)
Quality of life as assessed by the Quality of Life in Epilepsy (QOLIE-10-P) survey	The range of total scores for the QOLIE-10-P survey is 1 to 5, with 1 indicating a better outcome.	Baseline
Quality of life as assessed by the Quality of Life in Epilepsy (QOLIE-10-P) survey	The range of total scores for the QOLIE-10-P survey is 1 to 5, with 1 indicating a better outcome.	end of study (3 months after enrollment)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Texas Neurological Society Research Grant-2020
• Investigators: Principal Investigator: Katherine Harris, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Actual): September 2, 2022
• Study Completion (Actual): September 2, 2022

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: exercise; epilepsy; activity tracker
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: HSC-MS-20-0173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No