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临床试验/NCT05066880
NCT05066880已完成不适用

Investigation of the Effects of Yoga and Aerobic Exercise Training on Physical and Mental Health in People With Epilepsy

Dokuz Eylul University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2021年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Physical activity in daily life

研究概览

简要总结

In recent years, there is growing interest in illustrating the health benefits of exercise among epilepsy. Although exercise is recommended for patients with epilepsy, there is uncertainty concerning the effects of yoga and aerobic exercise on multiple health outcomes in epilepsy. The aim of this trial is to examine the effects of yoga and aerobic exercise training on physical activity, health-related physical fitness, mental, emotional, and psychological health status, seizure frequency and quality of life.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with epilepsy diagnosed by a neurologist using the International League Against Epilepsy (ILAE) criteria,
  • Having access to the internet at least three per week.

排除标准

  • Any history of neurological disorders other than epilepsy,
  • Significant physical and cognitive impairments,
  • Musculoskeletal comorbid conditions,
  • Contraindications for an exercise intervention including diagnosed cardiovascular, pulmonary, or endocrine diseases,
  • Pregnancy,
  • Mental deficiency or low education level to understand the questionnaires,
  • Currently participating in an exercise program,
  • Volunteers who miss 3 consecutive intervention sessions, and do not participate in 10% of sessions.

结局指标

主要结局

Physical activity in daily life

时间窗: change from baseline to 8 weeks

Physical activity will be objectively monitored with an accelerometer.

Seizure

时间窗: change from baseline to 8 weeks

Participants will be given a seizure diary and requested to record the number of their seizure.

次要结局

  • 30-second Chair Stand test(change from baseline to 8 weeks)
  • Bioelectrical impedance analyzer(change from baseline to 8 weeks)
  • Six-Minute Walk test(change from baseline to 8 weeks)
  • Waist and hip circumference(change from baseline to 8 weeks)
  • Weschler Memory Scale-Revised Visual Reproduction subtest(change from baseline to 8 weeks)
  • 10-item Perceived Stress Scale(change from baseline to 8 weeks)
  • Pittsburg Sleep Quality Index(change from baseline to 8 weeks)
  • Trail Making test and Digit Span test(change from baseline to 8 weeks)
  • Stroop test and Verbal Fluency(change from baseline to 8 weeks)
  • Biodex Balance System(change from baseline to 8 weeks)
  • Oktem Verbal Memory Processes test(change from baseline to 8 weeks)
  • Generalized Anxiety Disorder-7(change from baseline to 8 weeks)
  • Fatigue Impact Scale(change from baseline to 8 weeks)
  • Quality of Life in Epilepsy Inventory-31(change from baseline to 8 weeks)
  • Clock Drawing test(change from baseline to 8 weeks)
  • Neurological Disorders Depression Inventory for Epilepsy(change from baseline to 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Burcin Aktar

Institute of Health Sciences

Dokuz Eylul University

研究点 (2)

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Yoga and Aerobic Exercise in Epilepsy | 临床试验