Pilot Study Examining the Efficacy of Kiko Exercises on the Prevention of Migraine Headaches
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in Migraine Frequency and Severity from Baseline
研究概览
简要总结
This pilot study hopes to show that after 3 months of Kiko training, Kiko naive patients with migraine will have a decrease in the frequency and severity of their migraines.
详细描述
3.1 Study Design
Eligible subjects in this pilot study will be taught a series of Kiko exercises. Subjects who meet inclusion and exclusion criteria at the screening visit will be given a diary in which they will document their migraine frequency and severity for one month. Once subject diaries are complete, subjects will meet for a group lesson to learn the background of Kiko and study exercises. A DVD or videotape will be issued for subjects to use during practice at home. Subjects will maintain a diary of their migraine headaches, as well as a diary of their exercise routines. Subjects will meet weekly to reinforce training and encourage training continuation. Diaries will be collected at the end of the first, second, and third months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, 18 to 70 years of age, with at least a 1-year history of migraine headaches
- •With or without aura, (IHS criteria 1.1 and 1.2), who have experienced at least 4 migraines a month, or 2-3 migraines a month that last 2-3 days per attack in each of the 3 months prior to screening.
- •The subjects must be naïve to Kiko and Qigong training.
排除标准
- •Subject has any cardiac condition, as determined by the investigator, that would preclude safe participation in a low level exercise program.
- •Uncontrolled hypertension at screening (sitting systolic pressure >160 mmHg, diastolic pressure >95 mmHg.)
- •Subject has had tension-type headaches, >15 days/month in any of the 3 months prior to screening.
- •Subject has more than 8 migraines per month, or more than 16 days of migraine per month.
- •Subject is pregnant or expects to become pregnant during the course of the trial.
- •Subject has substance or alcohol abuse within the the last year which, in the investigator's judgement, will interfere with the study conduct, cooperation or evaluation and interpretation of the study results.
- •Subject has any concurrent medical or psychological condition that, in the investigator's opinion, may affect the interpretation of efficacy or safety data or which otherwise contraindicates participation in the trial.
- •Subject has participated in an investigational drug trial within the previous 4 weeks.
- •Subject uses pain medication in excess of 40 doses of over the counter medication and/or prescription pain medication per month to treat headaches of any type.
- •Subject is unable to differentiate between migraine and non-migraine headaches.
研究组 & 干预措施
Pilot Trial
Behavioral Intervention Kiko exercises-combines breathing and movement all study subjects no placebo or control group
干预措施: Kiko exercises-combines breathing and movement (Behavioral)
结局指标
主要结局
Change in Migraine Frequency and Severity from Baseline
时间窗: 3 months
Change in Migraine Frequency and Severity from Baseline on LIkert Scale 1-4
次要结局
- Change in number of headache free days(3 months)
- Subject satisfaction with Kiko training(3 months)
- Change in overall quality of life(3 month)
- Change in number of migraine free days(3 months)
研究者
Victor Elinoff MD
Principal Investegator
Regional Clinical Research