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

NCT ID: NCT04357912

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-16

Study Completion Date

2022-09-02

Brief Summary

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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

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Conditions

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Epilepsy

Keywords

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epilepsy exercise activity tracker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental group

Group Type EXPERIMENTAL

Activity Tracker Group

Intervention Type BEHAVIORAL

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.

Control Group

Group Type ACTIVE_COMPARATOR

Standard of Care Group

Intervention Type BEHAVIORAL

Participants will receive standard of care exercise education.

Interventions

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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.

Intervention Type BEHAVIORAL

Standard of Care Group

Participants will receive standard of care exercise education.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas Neurological Society Research Grant-2020

UNKNOWN

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Katherine Marie Johns Harris

Clinical Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katherine Harris, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-20-0173

Identifier Type: -

Identifier Source: org_study_id