A Telehealth Physical Exercise Intervention for the Treatment of Drug Resistant Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Proportion of participants recruited
研究概览
简要总结
The purpose of this research study is to determine whether a 12-week telehealth aerobic exercise intervention is feasible in people with epilepsy.
The study team will also gather information on the effect of the intervention on sleep and stress as mediators of seizure frequency, well as effects on epilepsy and epilepsy associated comorbidities.
详细描述
This is a randomized, controlled pilot trial to assess the feasibility and fidelity of a 12 week, individualized, telehealth exercise intervention in people with refractory epilepsy. This will be carried out using a 2 arm, parallel group design with a waitlist attention control.
Participants will undergo formal exercise testing prior to enrollment to determine safety and establish a baseline fitness level. Participants will use a wrist-worn Garmin device to record activity and sleep. After a 4 week baseline period, participants will be randomized to intervention or wait-list attention control. The intervention group will undergo a 12-week telehealth exercise program designed by a trained health coach and tailored to the individual's personal fitness level and exercise preferences. The intervention is based in social cognitive theory to implement and enforce sustainable behavior change. The wait-list attention control will receive health education but will not be given an exercise program. At the end of the intervention period, the control group will be given the option to participate in the exercise program.
The study will assess recruitment and retention as well as fidelity, acceptability and sustainability of a telehealth exercise intervention in this population.
The study will investigate objective and subjective measures of the effect of the intervention on the known seizure triggers of sleep and stress as possible mediators of seizure frequency.
The study will collect information regarding the effects of the intervention on depression, anxiety, quality of life, cognition, and seizure frequency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Due to the nature of the intervention, participants will not be blinded as to whether they are in the intervention or control group.
Blinded study staff will perform all pre-and post outcome assessments. The PI will also be blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Focal or generalized epilepsy, as clinically determined by a Wake Forest Baptist Health epileptologist.
- •Seizure frequency of at least 1 clinically observable seizure in the year prior to enrollment
- •Able to ambulate independently without assistive device
- •Access to a smartphone with application capabilities
- •Internet access or cellular data plan to attend virtual sessions
排除标准
- •Diagnosis of nonepileptic or psychogenic spells
- •Seizures associated with frequent falls with injury
- •<50% adherence with wearing the device or completing the study diary during the baseline period.
- •Currently in an exercise program
- •Medical conditions that would limit ability to participate in an exercise intervention such as:
- •Stage III or IV Congestive Heart Failure (CHF)
- •End-stage Renal Disease
- •Severe dementia or significant cognitive impairment
- •Uncontrolled hypertension (HTN)
- •Motor conditions that limit ambulation
结局指标
主要结局
Proportion of participants recruited
时间窗: Week 0 Baseline
This outcome measure assesses Feasibility of Recruitment. Recruitment will be calculated as a percentage by dividing the total number of enrolled participants by the total number of eligible participants.
Proportion of participants completing all visits
时间窗: Visit 3 (Week 16 after Baseline)
This outcome measure assesses Feasibility of Retention. Retention will be calculated as the percentage of all participants who complete Visit 2 Week 16 (End of Intervention) out of the total number of participants enrolled.
次要结局
- Proportion of Participants who achieve their target(Visit 3 (Week 16 after Baseline))
- Acceptability of the Intervention Questionnaire(Week 16 and Week 28 after baseline)
- Percentage of participants achieving the goal for at least 10 weeks(Week 28 after baseline)