Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT05359003
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.
Study:
NCT05359003
Study Brief:
Protocol Section:
NCT05359003