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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04357912
Enrollment
80
Registered
2020-04-22
Start date
2020-06-16
Completion date
2022-09-02
Last updated
2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

epilepsy, exercise, activity tracker

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.

Interventions

BEHAVIORALActivity 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.

Participants will receive standard of care exercise education.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of steps taken by participant3 months after enrollment
Total distance traveled by participant3 months after enrollment
Total time participant is active3 months after enrollmentmeasured in minutes

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026