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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001420 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The purpose of this research study is to evaluate the feasibility of a 12-week, telehealth delivered, step-goal based physical activity intervention in people with epilepsy. The study team will also evaluate the physical activity profiles of people with epilepsy both at rest and when engaged in physical activity and gather information on the effect of the intervention on epilepsy and epilepsy associated comorbidities.
This is a randomized, controlled, pilot trial to assess the feasibility of a 12-week telehealth delivered, step-goal based physical activity intervention in people with epilepsy. This will be carried out using a 2-arm, parallel group design with a healthy living education control. Participants will undergo formal exercise testing to establish a baseline fitness level and safety of participation. They will wear Garmin activity tracker on their wrist throughout the study to track their steps. During a 4 week baseline period, we will gather data on baseline physical activity levels and seizure frequency. Participants will then be randomized to either the intervention group or a healthy living education control group. The intervention group will undergo a 12-week, telehealth delivered, step goal based physical activity intervention with a goal of ultimately achieving at least 8,000 steps per day. The intervention will utilize social cognitive theory to encourage lasting behavior changes and have weekly group coaching sessions with a trained health and behavior change provider. The control group will receive education every two weeks but will not be given a coaching plan. The study will evaluate adherence to the intervention, sustainability of the intervention over 12 weeks after the formal coaching program ends, and acceptability of the intervention. The study will also investigate the physical activity profile of people with epilepsy both at rest and when asked to participate in physical activity with a self-selected intensity and bout duration. The study will collect information on the effect of the intervention on seizures, mood, quality of life, sleep, fitness, and heart-rate variability, as well as other epilepsy relevant outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Physical Activity Intervention | Experimental | Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach. |
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| Arm 2: Control | No Intervention | Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-week Physical Activity Program | Behavioral | Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Achieve Their Assigned Step Goal - Adherence | As measured by average daily steps via the Garmin device over the last 4 weeks of the intervention period. | Week 12 to Week 16 |
| Proportion of Participants Who Achieve Their Assigned Step Goal - Sustainability | As measured by average daily steps via the Garmin device over the last 4 weeks of the maintenance period, will be calculated and 95% binomial confidence intervals generated. | Week 24 to Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Time Spent Sedentary | Time spent sedentary during the last week of baseline as measured by the Garmin watch. | Week 4 |
| Time Spent in Light Intensity Activity | Time spent in light intensity in the last week of baseline as measured by the Garmin watch. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Halley Alexander, MD | Wake Forest Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
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During a 4-week baseline period, the participants will continue their usual activity but will wear the Garmin and ActivPAL 4 and keep a study diary. We will use this to assess their baseline PA profiles and seizure frequency and to screen for adherence with device and diary use, as participants who have <75% complete days of seizure recording or step data via the Garmin will not be randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Physical Activity Intervention | Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach. |
| FG001 | Arm 2: Control | Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Physical Activity Intervention | Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach. |
| BG001 | Arm 2: Control |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Who Achieve Their Assigned Step Goal - Adherence | As measured by average daily steps via the Garmin device over the last 4 weeks of the intervention period. | Pre-specified to collect data and report results for Arm 1: Physical Activity Intervention only. | Posted | Number | 95% Confidence Interval | Proportion | Week 12 to Week 16 |
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7 months (Day 0 - Week 28)
Adverse Events include worsening of seizure frequency, falls, and injuries. These will be recorded by the participant in their study diary, which will be returned electronically daily.
All other adverse events will be collected at each study visit (visits 2-4) by asking "have you had any health problems since your last visit?"
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Exercise Intervention | Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). 12-week physical activity program: Program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall with injury that required medical attention | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation at site of activity monitor | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Halley Alexander, MD, MS, FACNS | Wake Forest University School of Medicine | 336-716-6898 | halley.alexander@advocatehealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 21, 2024 | Sep 19, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2024 | Jan 30, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001519 | Behavior |
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A randomized, controlled trial with a two-arm, parallel group design with a healthy living education control
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| Week 4 |
| Time Spent in Moderate Intensity Activity | Time spent in moderate intensity in the last week of baseline as measured by the Garmin watch. | Week 4 |
| Time Spent in Vigorous Intensity Activity | Time spent in vigorous intensity in the last week of baseline as measured by the Garmin watch. | Week 4 |
| Exit Survey | The scale ranges from 4-20 with higher scores indicating greater satisfaction with the study. | Week 28 |
| Exercise Satisfaction Survey- Proportion of Participants With a 4 or Higher Response | We will use the question "How satisfied were you with the exercise intervention?" with scale of 1-5, 1=VERY UNSATISFIED, 2=UNSATISFIED, 3=NEUTRAL, 4=SATISFIED, 5=VERY SATISFIED. Higher numbers denotes better outcomes. We will calculate the proportion of subjects who answer 4 or above. | Week 16 |
| Time Spent Sedentary | Time spent sedentary during the last week of intervention as measured by the Garmin watch. | Week 16 |
| Time Spent Sedentary | Time spent sedentary during the last week of maintenance as measured by the Garmin watch. | Week 28 |
| Time Spent in Light Intensity Activity | Time spent in light intensity in the last week of intervention as measured by the Garmin watch. | Week 16 |
| Time Spent in Light Intensity Activity | Time spent in light intensity in the last week of maintenance as measured by the Garmin watch. | Week 28 |
| Time Spent in Moderate Intensity Activity | Time spent in moderate intensity in the last week of intervention as measured by the Garmin watch. | Week 16 |
| Time Spent in Moderate Intensity Activity | Time spent in moderate intensity in the last week of maintenance as measured by the Garmin watch. | Week 28 |
| Time Spent in Vigorous Intensity Activity | Time spent in vigorous intensity in the last week of intervention as measured by the Garmin watch. | Week 16 |
| Time Spent in Vigorous Intensity Activity | Time spent in vigorous intensity in the last week of maintenance as measured by the Garmin watch. | Week 28 |
Participants randomized to the healthy living education control group will continue to undergo standard care for 12 weeks with a phone call from the coach every 2 weeks on topics of healthy living (topics include: keeping a seizure diary, sleep, medication adherence, stress, diet, emotional health) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Participants |
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| Primary | Proportion of Participants Who Achieve Their Assigned Step Goal - Sustainability | As measured by average daily steps via the Garmin device over the last 4 weeks of the maintenance period, will be calculated and 95% binomial confidence intervals generated. | Pre-specified to collect data and report results for Arm 1: Physical Activity Intervention only. | Posted | Number | 95% Confidence Interval | Proportion | Week 24 to Week 28 |
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|
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| Secondary | Time Spent Sedentary | Time spent sedentary during the last week of baseline as measured by the Garmin watch. | Posted | Mean | 95% Confidence Interval | avg minutes per week spent sedentary | Week 4 |
|
|
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| Secondary | Time Spent in Light Intensity Activity | Time spent in light intensity in the last week of baseline as measured by the Garmin watch. | Posted | Mean | 95% Confidence Interval | avg minutes per week in light intensity | Week 4 |
|
|
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| Secondary | Time Spent in Moderate Intensity Activity | Time spent in moderate intensity in the last week of baseline as measured by the Garmin watch. | Posted | Mean | 95% Confidence Interval | avg minutes per week in moderate | Week 4 |
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|
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| Secondary | Time Spent in Vigorous Intensity Activity | Time spent in vigorous intensity in the last week of baseline as measured by the Garmin watch. | Posted | Mean | 95% Confidence Interval | avg minutes per week in vigorous | Week 4 |
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| Secondary | Exit Survey | The scale ranges from 4-20 with higher scores indicating greater satisfaction with the study. | For the Control Group: 3 dropouts participants did not complete the survey, and 1 participant only partially completed this form. Only 2 were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Week 28 |
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| Secondary | Exercise Satisfaction Survey- Proportion of Participants With a 4 or Higher Response | We will use the question "How satisfied were you with the exercise intervention?" with scale of 1-5, 1=VERY UNSATISFIED, 2=UNSATISFIED, 3=NEUTRAL, 4=SATISFIED, 5=VERY SATISFIED. Higher numbers denotes better outcomes. We will calculate the proportion of subjects who answer 4 or above. | Pre-specified to collect data and report results for Arm 1: Physical Activity Intervention only. Only 13 participants were analyzed because 1 participant dropped out and 1 participant did not complete the survey. | Posted | Count of Participants | Participants | Week 16 |
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| Secondary | Time Spent Sedentary | Time spent sedentary during the last week of intervention as measured by the Garmin watch. | Posted | Mean | 95% Confidence Interval | avg minutes per week spent sedentary | Week 16 |
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| Secondary | Time Spent Sedentary | Time spent sedentary during the last week of maintenance as measured by the Garmin watch. | Posted | Mean | 95% Confidence Interval | avg minutes per week spent sedentary | Week 28 |
|
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| Secondary | Time Spent in Light Intensity Activity | Time spent in light intensity in the last week of intervention as measured by the Garmin watch. | Posted | Mean | 95% Confidence Interval | avg minutes per week in light intensity | Week 16 |
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| Secondary | Time Spent in Light Intensity Activity | Time spent in light intensity in the last week of maintenance as measured by the Garmin watch. | Posted | Mean | 95% Confidence Interval | avg minutes per week in light intensity | Week 28 |
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| Secondary | Time Spent in Moderate Intensity Activity | Time spent in moderate intensity in the last week of intervention as measured by the Garmin watch. | Posted | Mean | 95% Confidence Interval | avg minutes per week in moderate | Week 16 |
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| Secondary | Time Spent in Moderate Intensity Activity | Time spent in moderate intensity in the last week of maintenance as measured by the Garmin watch. | Posted | Mean | 95% Confidence Interval | avg minutes per week in moderate | Week 28 |
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| Secondary | Time Spent in Vigorous Intensity Activity | Time spent in vigorous intensity in the last week of intervention as measured by the Garmin watch. | Posted | Mean | 95% Confidence Interval | avg minutes per week in vigorous | Week 16 |
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| Secondary | Time Spent in Vigorous Intensity Activity | Time spent in vigorous intensity in the last week of maintenance as measured by the Garmin watch. | Posted | Mean | 95% Confidence Interval | avg minutes per week in vigorous | Week 28 |
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| 0 |
| 15 |
| 4 |
| 15 |
| 11 |
| 15 |
| EG001 | Arm 2: Control | Participants randomized to the wait-list attention control group will continue to undergo standard care for 12 weeks. | 0 | 6 | 1 | 6 | 4 | 6 |
| Dizziness that resulted in ER visit | Cardiac disorders | Systematic Assessment |
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| Weakness that resulted in ER visit | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Planned admission for electrode implant placement | Nervous system disorders | Systematic Assessment |
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| Seizure with minor injury (not during exercise) | Nervous system disorders | Systematic Assessment |
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| Dizziness and vomiting | General disorders | Systematic Assessment |
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| Bumped into furniture | General disorders | Systematic Assessment |
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| Seizure frequency increased | Nervous system disorders | Systematic Assessment | Seizure activity noted in the daily diary indicated an increase in seizures from baseline. Per protocol, temporal relationship with exercise was reviewed and not temporally related to exercise. |
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| Depression episode | Psychiatric disorders | Systematic Assessment |
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| Headache or migraine | Nervous system disorders | Systematic Assessment |
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| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Kidney stone | Renal and urinary disorders | Systematic Assessment |
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| Lipoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Lupus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Minor fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Strep throat | General disorders | Systematic Assessment |
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| Seizure within 30 min of physical activity | Nervous system disorders | Systematic Assessment |
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| Routine surgery to replace battery medical device | Surgical and medical procedures | Systematic Assessment |
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| Seizure frequency increased | Nervous system disorders | Systematic Assessment | Self-reported an increase of seizures (two seizures in one day) |
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