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临床试验/NCT02950636
NCT02950636已完成不适用

Effect of Yoga on Mood and Quality of Life in Patients With Refractory Epilepsy

University of Kansas Medical Center2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2016年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
2
主要终点
Change in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)

研究概览

简要总结

The purpose of this study is to learn if a structured yoga program can reduce anxiety, improve depression, and improve quality of life in patients with medication resistant epilepsy (MRE).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of unilateral or bilateral temporal lobe epilepsy
  • Presence 3 or more seizures per month
  • No medical contraindications to yoga
  • Willing and able to perform simple non strenuous yoga exercises
  • Ability to get on the floor and up again without assistance
  • Ambulatory
  • Ability to travel to the yoga class twice a week

排除标准

  • Any yoga in the last 6 months
  • Inability to perform yoga exercises
  • History of epilepsy surgery within the last year
  • Currently pregnant or less than 6 week postpartum

研究组 & 干预措施

Restorative Yoga

Experimental

Subjects will participate in a structured restorative yoga program. Subjects will attend a 60 minute restorative yoga class twice a week for 8 weeks in a yoga studio.

干预措施: Yoga (Other)

结局指标

主要结局

Change in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)

时间窗: Change from Week 4 to Week 12

The NDDI-E is a 6 item questionnaire. Scores for each question range from 1 (never) to 4 (all the time). There is a maximum score of 24. The higher the score the more severe the depression.

次要结局

  • Change in Generalized Anxiety Disorder 7-item (GAD-7) scale(Change from Week 4 to Week 12)
  • Change in Quality of Life in Epilepsy-Patient-Weighted (QOLIE-31-p)(Change from Baseline to Week 12)
  • Frequency of seizures(Week 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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