Steps for Epilepsy — StEpi  

Epilepsy Clinical Trial

Official title: A Feasibility Study of a Step-goal Based Physical Activity Intervention in People With Epilepsy

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 wait list attention 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 of a wait-list 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. At the end of the intervention period, the control group will have the option to participate in the intervention while the intervention group will be evaluated for another 12 weeks to assess sustainability. The study will evaluate adherence to the intervention 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. ;

Related Conditions & MeSH terms

• Epilepsy

• NCT number: NCT05359003
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 13, 2023
• Completion date: September 2024