Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT05359003
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Week 12 to Week 16
As measured by average daily steps via the Garmin device over the last 4 weeks of the intervention period.
Time frame: 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.
Time frame: Week 4
Time spent sedentary during the last week of baseline as measured by the Garmin watch.
Time frame: Week 4
Time spent in light intensity in the last week of baseline as measured by the Garmin watch.
Time frame: Week 4
Time spent in moderate intensity in the last week of baseline as measured by the Garmin watch.
Time frame: Week 4
Time spent in vigorous intensity in the last week of baseline as measured by the Garmin watch.
Time frame: Week 28
The scale ranges from 4-20 with higher scores indicating greater satisfaction with the study.
Time frame: 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.
Time frame: Week 16
Time spent sedentary during the last week of intervention as measured by the Garmin watch.
Time frame: Week 28
Time spent sedentary during the last week of maintenance as measured by the Garmin watch.
Time frame: Week 16
Time spent in light intensity in the last week of intervention as measured by the Garmin watch.
Time frame: Week 28
Time spent in light intensity in the last week of maintenance as measured by the Garmin watch.
Time frame: Week 16
Time spent in moderate intensity in the last week of intervention as measured by the Garmin watch.
Time frame: Week 28
Time spent in moderate intensity in the last week of maintenance as measured by the Garmin watch.
Time frame: Week 16
Time spent in vigorous intensity in the last week of intervention as measured by the Garmin watch.
Time frame: Week 28
Time spent in vigorous intensity in the last week of maintenance as measured by the Garmin watch.
Wake Forest University Health Sciences
Other
A Feasibility Study of a Step-goal Based Physical Activity Intervention in People With Epilepsy
Acronym: StEpi
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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