Epilepsy
Conditions
Keywords
physical activity, step goal, tele health
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORAL12-week Physical Activity Program
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.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
A randomized, controlled trial with a two-arm, parallel group design with a healthy living education control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Focal or generalized epilepsy, as determined clinically by a WFBH epileptologist with no significant consideration of an alternative diagnosis * Access to a smartphone with application capabilities * Internet access or cellular data plan to attend virtual sessions * Able to ambulate independently
Exclusion criteria
* Diagnosis of nonepileptic or psychogenic spells * Seizures associated with falls with injury (such as atonic seizures) * Medical conditions that would limit ability to participate in an exercise intervention including: Stage III or IV Congestive Heart Failure (CHF); End-stage Renal Disease; Severe dementia or significant cognitive impairment that precludes participation in the intervention or limits ability to follow the study protocol; Uncontrolled hypertension (HTN) defined as systolic blood pressure greater than 180 mmHg and diastolic blood pressure greater than 110 mmHg at rest; Severe arthritis, amputations, or orthopedic problems that limit ambulatory ability * Currently pregnant or plan to become pregnant during the study period (16 weeks) * An active Central Nervous System (CNS) infection, demyelinating disease, degenerative neurologic disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results * Any clinically significant psychiatric illness, psychological, or behavioral problems that would interfere with the subject's ability to participate in the study. * Unwilling or unable to comply with all study visits and procedures * Participants who have \<75% complete days of seizure recording in the study diary or step data via the Garmin device will not be randomized.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Achieve Their Assigned Step Goal - Adherence | Week 12 to Week 16 | As measured by average daily steps via the Garmin device over the last 4 weeks of the intervention period. |
| Proportion of Participants Who Achieve Their Assigned Step Goal - Sustainability | Week 24 to Week 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent in Moderate Intensity Activity | Week 4 | Time spent in moderate intensity in the last week of baseline as measured by the Garmin watch. |
| Time Spent in Vigorous Intensity Activity | Week 4 | Time spent in vigorous intensity in the last week of baseline as measured by the Garmin watch. |
| Time Spent Sedentary | Week 4 | Time spent sedentary during the last week of baseline as measured by the Garmin watch. |
| Exercise Satisfaction Survey- Proportion of Participants With a 4 or Higher Response | Week 16 | 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. |
| Exit Survey | Week 28 | The scale ranges from 4-20 with higher scores indicating greater satisfaction with the study. |
| Time Spent in Light Intensity Activity | Week 4 | Time spent in light intensity in the last week of baseline as measured by the Garmin watch. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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) | 6 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Arm 2: Control | Total | Arm 1: Physical Activity Intervention |
|---|---|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 7.66 | 36.41 years STANDARD_DEVIATION 10.89 | 37.5 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 21 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 17 Participants | 12 Participants |
| Sex: Female, Male Female | 3 Participants | 13 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 6 |
| other Total, other adverse events | 11 / 15 | 4 / 6 |
| serious Total, serious adverse events | 4 / 15 | 1 / 6 |
Outcome results
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.
Time frame: Week 12 to Week 16
Population: Pre-specified to collect data and report results for Arm 1: Physical Activity Intervention only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Physical Activity Intervention | Proportion of Participants Who Achieve Their Assigned Step Goal - Adherence | 0.267 Proportion |
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.
Time frame: Week 24 to Week 28
Population: Pre-specified to collect data and report results for Arm 1: Physical Activity Intervention only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Physical Activity Intervention | Proportion of Participants Who Achieve Their Assigned Step Goal - Sustainability | 0.143 Proportion |
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.
Time frame: Week 16
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Physical Activity Intervention | Exercise Satisfaction Survey- Proportion of Participants With a 4 or Higher Response | 9 Participants |
Secondary
Exit Survey
The scale ranges from 4-20 with higher scores indicating greater satisfaction with the study.
Time frame: Week 28
Population: For the Control Group: 3 dropouts participants did not complete the survey, and 1 participant only partially completed this form. Only 2 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Physical Activity Intervention | Exit Survey | 18.43 score on a scale | Standard Deviation 1.95 |
| Arm 2: Control | Exit Survey | 17.50 score on a scale | Standard Deviation 2.12 |
Secondary
Time Spent in Light Intensity Activity
Time spent in light intensity in the last week of intervention as measured by the Garmin watch.
Time frame: Week 16
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1: Physical Activity Intervention | Time Spent in Light Intensity Activity | 374 avg minutes per week in light intensity |
| Arm 2: Control | Time Spent in Light Intensity Activity | 355 avg minutes per week in light intensity |
Secondary
Time Spent in Light Intensity Activity
Time spent in light intensity in the last week of maintenance as measured by the Garmin watch.
Time frame: Week 28
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1: Physical Activity Intervention | Time Spent in Light Intensity Activity | 305 avg minutes per week in light intensity |
| Arm 2: Control | Time Spent in Light Intensity Activity | 742 avg minutes per week in light intensity |
Secondary
Time Spent in Light Intensity Activity
Time spent in light intensity in the last week of baseline as measured by the Garmin watch.
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1: Physical Activity Intervention | Time Spent in Light Intensity Activity | 364 avg minutes per week in light intensity |
| Arm 2: Control | Time Spent in Light Intensity Activity | 297 avg minutes per week in light intensity |
Secondary
Time Spent in Moderate Intensity Activity
Time spent in moderate intensity in the last week of baseline as measured by the Garmin watch.
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1: Physical Activity Intervention | Time Spent in Moderate Intensity Activity | 99.6 avg minutes per week in moderate |
| Arm 2: Control | Time Spent in Moderate Intensity Activity | 45 avg minutes per week in moderate |
Secondary
Time Spent in Moderate Intensity Activity
Time spent in moderate intensity in the last week of maintenance as measured by the Garmin watch.
Time frame: Week 28
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1: Physical Activity Intervention | Time Spent in Moderate Intensity Activity | 179 avg minutes per week in moderate |
| Arm 2: Control | Time Spent in Moderate Intensity Activity | 141 avg minutes per week in moderate |
Secondary
Time Spent in Moderate Intensity Activity
Time spent in moderate intensity in the last week of intervention as measured by the Garmin watch.
Time frame: Week 16
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1: Physical Activity Intervention | Time Spent in Moderate Intensity Activity | 175 avg minutes per week in moderate |
| Arm 2: Control | Time Spent in Moderate Intensity Activity | 110 avg minutes per week in moderate |
Secondary
Time Spent in Vigorous Intensity Activity
Time spent in vigorous intensity in the last week of maintenance as measured by the Garmin watch.
Time frame: Week 28
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1: Physical Activity Intervention | Time Spent in Vigorous Intensity Activity | 57.3 avg minutes per week in vigorous |
| Arm 2: Control | Time Spent in Vigorous Intensity Activity | 160 avg minutes per week in vigorous |
Secondary
Time Spent in Vigorous Intensity Activity
Time spent in vigorous intensity in the last week of baseline as measured by the Garmin watch.
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1: Physical Activity Intervention | Time Spent in Vigorous Intensity Activity | 81.6 avg minutes per week in vigorous |
| Arm 2: Control | Time Spent in Vigorous Intensity Activity | 40.8 avg minutes per week in vigorous |
Secondary
Time Spent in Vigorous Intensity Activity
Time spent in vigorous intensity in the last week of intervention as measured by the Garmin watch.
Time frame: Week 16
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1: Physical Activity Intervention | Time Spent in Vigorous Intensity Activity | 61.7 avg minutes per week in vigorous |
| Arm 2: Control | Time Spent in Vigorous Intensity Activity | 156 avg minutes per week in vigorous |
Secondary
Time Spent Sedentary
Time spent sedentary during the last week of intervention as measured by the Garmin watch.
Time frame: Week 16
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1: Physical Activity Intervention | Time Spent Sedentary | 5608 avg minutes per week spent sedentary |
| Arm 2: Control | Time Spent Sedentary | 5344 avg minutes per week spent sedentary |
Secondary
Time Spent Sedentary
Time spent sedentary during the last week of baseline as measured by the Garmin watch.
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1: Physical Activity Intervention | Time Spent Sedentary | 4790 avg minutes per week spent sedentary |
| Arm 2: Control | Time Spent Sedentary | 3356 avg minutes per week spent sedentary |
Secondary
Time Spent Sedentary
Time spent sedentary during the last week of maintenance as measured by the Garmin watch.
Time frame: Week 28
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1: Physical Activity Intervention | Time Spent Sedentary | 4266 avg minutes per week spent sedentary |
| Arm 2: Control | Time Spent Sedentary | 5697 avg minutes per week spent sedentary |