The Effect of Aerobic Exercise Training for Migraine Prevention.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Frequency of Migraine/month
研究概览
简要总结
This study has been designed in order to know the effect of 12 weeks of aerobic exercise training for migraine prevention. We hypothesized that the exercise training could reduce the number of days with migraine and the number of attacks per month in the treated group.
详细描述
The study will cover 20 weeks. The first 8 weeks has been designed as "baseline" period, to assess the migraine status and classification, colect blood exam, perform a cardiopulmonary exercise test to determine the maximal oxygen uptake, and fill psychometric questionnaires. The remaining 12 weeks will be the "intervention" period, where participants after randomization will be allocated to perform an aerobic exercise training (on treadmill) performed on a 3 times per week-based program of 40-min duration each session, or will wait for the equal period to repeat all the assessments, then begin the same exercise protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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
- 是
入选标准
- •Sedentary (> 6 month) healthy subjects and sedentary (> 6 month)subjects with migraine without aura, migraine with aura and chronic migraine;
排除标准
- •Physically active(> 1 day/week);
- •Tobacco user;
- •Alcohol or abuse drug user;
- •Taking any prescribed medication or, in the case of medication for migraine prevention, if taking < 6 months.
- •Having any cardiovascular, pulmonary, endocrine-metabolic, rheumatic or other neurologic disease or psychiatric disorder such as bipolar disorder and post-traumatic stress disorder.
- •Undergoing surgical procedure less than 3 months before entering the study.
结局指标
主要结局
Frequency of Migraine/month
时间窗: Migraine frequency measured between 4th and 8th weeks has been set as the "baseline" period, and will be compared to changes in frequency measured between weeks 12 to 16, which has been set as "post-intervention" period.
Plasma levels of anandamide, cytokines and aminopeptidases
时间窗: Resting plasma levels measured between 4th and 8th weeks has been set as the "baseline" levels, and will be compared to changes in resting levels measured between weeks 12 to 16, set as the "post-intervention" levels.
次要结局
- Days with Migraine(Days with migraine measured between 4th and 8th weeks has been set as the "baseline" period, and will be compared to changes in days with migraine measured between weeks 12 to 16, which has been set as "post-intervention" period)
研究者
Arão Belitardo de Oliveira
Prof. BS. Arão Belitardo de Oliveira
Federal University of São Paulo