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

December 1, 2023 updated by: Katherine Marie Johns Harris, The University of Texas Health Science Center, Houston
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of steps taken by participant
Time Frame: 3 months after enrollment
3 months after enrollment
Total distance traveled by participant
Time Frame: 3 months after enrollment
3 months after enrollment
Total time participant is active
Time Frame: 3 months after enrollment
measured in minutes
3 months after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression as measured by the Patient Health Questionnaire depression scale (PHQ-9)
Time Frame: Baseline
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)
Time Frame: end of study (3 months after enrollment)
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)
Time Frame: Baseline
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)
Time Frame: end of study (3 months after enrollment)
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)
Time Frame: Baseline
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)
Time Frame: end of study (3 months after enrollment)
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
Time Frame: Baseline
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
Time Frame: 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.
end of study (3 months after enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Texas Neurological Society Research Grant-2020

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine Harris, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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