Randomized Controlled Study of the Effect of Cardiovascular Exercise in Uncontrolled Epilepsy: Efficacy, Side Effects and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Proportion of patients with at least 50% seizure reduction
研究概览
简要总结
This is an open-label randomized controlled tria testing if an improvement in cardiovascular fitness can improve quality of Life and reduce seizure frequency in patients with refractory epilepsy.. Before the intervention each subject will undergo an evaluation of baseline cardiovascular fitness. Patients will be randomized into two groups One group will listen to a relaxation tape 5 days per week for 6 months and the other group will receive a ergometric cycle and perform a predetermined level of exercise per day , 5 days per week for 6 months. Randomization will be conducted an external randomization center based on a sequence of random numbers.
Changes in concomitant antiepileptic drugs (AED) treatment during the study will be minimized, and restricted to AED changes deemed to be necessary to address AED-related toxicity.
Medical examination; body weight; fitness test, including ECG and BP measurements, seizure frequency; adverse effects (unstructured interview); details of concomitant concomitant treatment, mood assessment by using the Hospital Anxiety and Depression Scale-Anxiety (HADS); health related quality of life (RAND-36), E4-data downloading, will be done at baseline and after 6 months
Primary endpoint: Proportion of patients with at least 50% seizure reduction
Secondary endpoints: Median percent reduction in seizure frequency, HADS score, RAND-36 score, fitness score; adverse events, changes in concomitant AED treatment, E4 data
.
详细描述
Objectives
The primary objective of this study is to assess the effect of a 6-month course of standardized physical exercise, added on to pre-existing stable AED treatment, on seizure frequency in patients with epilepsy aged 16 to 65.
Secondary objectives include the assessment of the effect of a 6-month course of standardized physical exercise, added on to pre-existing stable AED treatment, on (i) depressive and anxiety symptom scores; (2) health-related quality of life; (3) adverse
events.
Study design
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
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16 years to 65 years
- •An established diagnosis of focal epilepsy
- •A frequency of at least 3 focal seizures (including focal to bilateral tonic-clonic) during a 4 week-prospective baseline, despite ongoing treatment with one to 4 AEDs
- •Stable AED treatment for at least 4 weeks, and no expected need to modify current AED treatment over the subsequent 6 months.
- •Capability to follow instructions (or has a caretaker who will help) and keep a seizure calendar
- •Ability to understand the purpose, procedures and potential risks and benefits associated with participation in the study;
- •Willingness to give freely written informed consent
排除标准
- •Any associated condition contraindicating non-competitive physical exercise
- •Patients already engaged in regular daily physical exercise program;
- •A history of seizures induced by exercise
- •A history of psychogenic non-epileptic seizures
- •Pregnancy or puerperium
- •Alcohol or substance abuse
- •Any condition (for example, an unstable or progressive medical condition) which, in the investigator's assessment, may interfere with the evaluation procedures or the objectives of the study
结局指标
主要结局
Proportion of patients with at least 50% seizure reduction
时间窗: Change from baseline at 6months
Determined by seizure diary
次要结局
- Median percent change in seizure frequency(Change from Baseline at 6 months)
- Change in anxiety and depression ratings(Change from Baseline at 6 months)
- Change in Health-Related Quality of Life(Change from Baseline at 6 months)
- Reduction in adverse event reporting(Improvement from baseline at 6 months)