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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 University1 个研究点 分布在 1 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
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Seizure

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
否

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.

研究组 & 干预措施

Yoga

Experimental

Participants allocated to the yoga group will receive the yoga-based intervention through an internet-based video conference remotely in real-time. Each class will accommodate a maximum of 5 subjects. A qualified physiotherapist who was a certificated yoga instructor will teach in these classrooms. The 8-week exercise intervention consists of three times per week sessions of yoga.

干预措施: Exercise training (Other)

Aerobic exercise

Experimental

Participants of the aerobic exercise group will be requested to perform unsupervised aerobic training in the home environment (e.g., at home, park, backyard, or in the local gym). The 8-week exercise intervention consists of three times per week sessions of aerobic exercise. Training will consist of a 10-min warm-up period, aerobic activity, and 5-min cool-down period.

干预措施: Exercise training (Other)

Wait-list

No Intervention

Participants in the wait-list group will be advised to continue their habitual physical activity next to usual medical care. A yoga or aerobic exercise program of 8 weeks will be offered after the ending of the study period.

结局指标

主要结局

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.

Physical activity in daily life

时间窗: change from baseline to 8 weeks

Physical activity will be objectively monitored with an accelerometer.

次要结局

  • 30-second Chair Stand test(change from baseline to 8 weeks)
  • Bioelectrical impedance analyzer(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)
  • Six-Minute Walk test(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 (1)

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