A Feasibility Study of a Step-goal Based Physical Activity Intervention in People With Epilepsy
概览
- 阶段
- 不适用
- 干预措施
- 12-week Physical Activity Program
- 疾病 / 适应症
- Epilepsy
- 发起方
- Wake Forest University Health Sciences
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Proportion of Participants Who Achieve Their Assigned Step Goal - Adherence
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 12-week Physical Activity Program
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)
结局指标
主要结局
Proportion of Participants Who Achieve Their Assigned Step Goal - Adherence
时间窗: 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
时间窗: 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.
次要结局
- Time Spent Sedentary(Week 28)
- Time Spent in Light Intensity Activity(Week 28)
- Time Spent in Moderate Intensity Activity(Week 28)
- Time Spent in Vigorous Intensity Activity(Week 28)
- Exit Survey(Week 28)
- Exercise Satisfaction Survey- Proportion of Participants With a 4 or Higher Response(Week 16)
- Time Spent Sedentary(Week 4)
- Time Spent in Light Intensity Activity(Week 4)
- Time Spent in Moderate Intensity Activity(Week 4)
- Time Spent in Vigorous Intensity Activity(Week 4)
- Time Spent Sedentary(Week 16)
- Time Spent in Light Intensity Activity(Week 16)
- Time Spent in Moderate Intensity Activity(Week 16)
- Time Spent in Vigorous Intensity Activity(Week 16)