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临床试验/NCT01407861
NCT01407861已完成不适用

Aerobic Endurance Training Versus Relaxation Training in Migraine Prophylaxis

Universität Duisburg-Essen2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Reduction of headache days in the last 4 weeks of the 12-week training compared to baseline (4 weeks before start of the training).

研究概览

简要总结

This is a single centre, open label, prospective, randomized study on the prophylactic effect of moderate aerobic endurance training versus relaxation training in patients with migraine.

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

  • Patient's signature on the informed consent document [each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form].
  • Patients have a clinical diagnosis of migraine with or without aura according to IHS criteria at least one year prior to enrollment.
  • Patients have a clinical diagnosis of migraine with or without aura and in addition a clinical diagnosis of tension type headache according to IHS criteria, if patients are able to differentiate between the two headache diagnoses and if migraine is more frequent in these patients
  • Patients that report at least three headache days per month

排除标准

  • Diseases or disabilities that disqualify to perform either aerobic endurance training or relaxation training
  • Language difficulties that disable to fill out questionnaires
  • Pregnancy
  • Additional diagnosis of secondary headache according to the IHS criteria

结局指标

主要结局

Reduction of headache days in the last 4 weeks of the 12-week training compared to baseline (4 weeks before start of the training).

时间窗: 16 weeks

次要结局

  • Number of headache days 12 weeks after finishing the training (follow up).(20 weeks)
  • Consumption of analgetic agents/triptans(20 weeks)
  • Increase in aerobic capability(12 weeks)
  • Psychological Impact of Training(20)
  • Impact on burden of disease(20 weeks)

研究者

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

Hans-Christoph Diener

Prof. of Neurology

Universität Duisburg-Essen

研究点 (2)

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