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Completed

NCT Number: NCT04357912

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

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.

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Key information

Conditions

Epilepsy Behavior Brain Diseases Central Nervous System Diseases Motor Activity Nervous System Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activity Tracker Group

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.

Standard of Care Group

Behavioral

Participants will receive standard of care exercise education.

Primary outcomes

  1. Number of steps taken by participant

    Time frame: 3 months after enrollment

  2. Total distance traveled by participant

    Time frame: 3 months after enrollment

  3. Total time participant is active

    Time frame: 3 months after enrollment

    measured in minutes

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Texas Neurological Society Research Grant-2020

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2020
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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