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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357912
• Other study ID #: HSC-MS-20-0173
• Status: Completed
• Phase: N/A
• Start date: June 16, 2020
• Est. completion date: September 2, 2022

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2, 2022
• Est. primary completion date: September 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.
• Standard of Care Group
Participants will receive standard of care exercise education.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Texas Neurological Society Research Grant-2020

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of steps taken by participant		3 months after enrollment
Primary	Total distance traveled by participant		3 months after enrollment
Primary	Total time participant is active	measured in minutes	3 months after enrollment
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)