NCT01407861已完成不适用
Aerobic Endurance Training Versus Relaxation Training in Migraine Prophylaxis
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
- 56
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Relaxation training
Active Comparator
Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.
干预措施: Relaxation Training (Other)
Aerobic endurance training
Active Comparator
Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.
干预措施: Aerobic endurance Training (Other)
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
- Impact on burden of disease(20 weeks)
- Psychological Impact of Training(20)
- 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)
研究者
Hans-Christoph Diener
Prof. of Neurology
Universität Duisburg-Essen
研究点 (1)
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