EpilepsyNCT04357912
Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?
A study testing Activity Tracker Group in people with Epilepsy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Activity Tracker Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2020to 2 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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.
- Conditions
- Epilepsy
- Being tested
- Activity Tracker Group, Standard of Care Group
- Keywords
- epilepsy, exercise, activity tracker
- Medical subject headings
- Epilepsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity Tracker GroupBehavioural
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 GroupBehavioural
Participants will receive standard of care exercise education.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Behavioral: Activity Tracker Group |
| Control Group | Active comparator | Not described Receives: Behavioral: Standard of Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps taken by participant
Measured: 3 months after enrollment
Total distance traveled by participant
Measured: 3 months after enrollment
Total time participant is active
measured in minutes
Measured: 3 months after enrollment
Secondary outcomes (8)
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
Measured: Baseline
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
Measured: end of study (3 months after enrollment)
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)
Measured: Baseline
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)
Measured: end of study (3 months after enrollment)
Sleep as measures by the Epworth Sleepiness Scale (ESS)
The ESS scale ranges form 0 (would never dose) to 3 (high chance of dozing)
Measured: Baseline
Sleep as measures by the Epworth Sleepiness Scale (ESS)
The ESS scale ranges form 0 (would never dose) to 3 (high chance of dozing)
Measured: end of study (3 months after enrollment)
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.
Measured: Baseline
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.
Measured: end of study (3 months after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start16 Jun 2020
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Neurological Society Research Grant-2020
- Responsible party
- Principal investigator, Katherine Marie Johns Harris, The University of Texas Health Science Center, Houston
- Investigators
- Katherine Harris, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357912
- Sponsor's protocol ID
- HSC-MS-20-0173
- Status last verified
- Dec 2023
- First submitted
- 20 Apr 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?
- ClinicalTrials.gov ID
- NCT04357912
- Acronym / sponsor ID
- HSC-MS-20-0173
- Conditions
- Epilepsy
- Keywords
- epilepsy, exercise, activity tracker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Texas Neurological Society Research Grant-2020
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Activity Tracker Group |
| Control Group | Active comparator | Behavioral: Standard of Care Group |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity Tracker GroupIn 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. | Behavioural | Experimental group |
| Standard of Care GroupParticipants will receive standard of care exercise education. | Behavioural | Control Group |
Primary outcome
Number of steps taken by participant
Time frame: 3 months after enrollment
Total distance traveled by participant
Time frame: 3 months after enrollment
Total time participant is active
Time frame: 3 months after enrollment
measured in minutes
8 secondary outcomes
Depression as measured by the Patient Health Questionnaire depression scale (PHQ-9)
Time frame: Baseline
Depression as measured by the Patient Health Questionnaire depression scale (PHQ-9)
Time frame: end of study (3 months after enrollment)
Anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7)
Time frame: Baseline
Anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7)
Time frame: end of study (3 months after enrollment)
Sleep as measures by the Epworth Sleepiness Scale (ESS)
Time frame: Baseline
Sleep as measures by the Epworth Sleepiness Scale (ESS)
Time frame: 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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Focal Epilepsy
Enrolling by invitation
Neural Mechanisms for Stopping Ongoing Speech Production (Study 2)
Epilepsy, Speech
Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Harris, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity Tracker Group in people with Epilepsy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of steps taken by participant (time frame: 3 months after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.