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

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Behavioral: Standard of Care Group; Behavioral: Activity Tracker Group

• Registration Number: NCT04357912
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-22
• Study Start: 2020-06-16
• Primary Completion: 2022-09-02
• Study Completion: 2022-09-02
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard of Care Group	-
Experimental group	Activity Tracker Group	-

Primary Outcome Measures

Name	Time	Method
Total distance traveled by participant	3 months after enrollment
Number of steps taken by participant	3 months after enrollment
Total time participant is active	3 months after enrollment	measured in minutes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States