Aerobic Training Effect on the Improvement of Pain Perception in Patients With Fibromyalgia and Migraine: a Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pain intensity (headache)
研究概览
简要总结
Fibromyalgia and migraine are diseases with high prevalence in women between the age group of 30-60 years, which seem to share the same pathophysiological mechanism; both originate from neuroendocrine disorders of the hypothalamic-pituitary axis in the central nervous system, and are therefore closely related. In addition to the strong relationship with migraine, fibromyalgia can also be associated with sleep disorders, chronic fatigue and psychological disorders. The combination of these factors decreases the quality of life and contributes to increased sedentary this population. It is known that physical exercise promotes positive changes in pain pathophysiological pathway to increase the release of endorphins neuroendógenas, improving the symptoms of fibromyalgia.
The objective of this study is to analyze whether the application of an aerobic exercise program may result in the reduction of the frequency, duration and intensity of migraine attacks in women with fibromyalgia. For this, a clinical trial will be conducted randomized double-blind clinical trial comparing two groups of women diagnosed with fibromyalgia and migraine. Initially, all answer questionnaires assessing quality of life, impact of headache, level of depression and anxiety, sleep quality, physical activity level, and; will be held ergospirometry for research in exercise tolerance. The experimental group will implement the protocol consists of heating, aerobic exercise according to the heart rate established for training by spirometry and slowdown; and the control group will hold the heat on low speed and heart rate will next baseline. Both groups will be followed for 12 weeks, with a frequency of three weekly meetings lasting 30 minutes and re-evaluated every 4 weeks. At the end of the protocol, the groups will have their results were compared and statistically analyzed.
详细描述
This study is classified as a randomized double-blind clinical trial. Will be held in the Department of Physiotherapy of the university clinic of the Federal University of Pernambuco, located in University City, Recife-PE. Data for the survey will be collected during the course of the Masters in Physiotherapy, from April 2015 to September 2015, for further analysis.
The analyzed groups shall consist of women aged 30-50 years referred to the Department of Physical Therapy - UFPE, with clinical diagnosis of fibromyalgia and migraine performed by doctors of Rheumatology clinics and Neurology, Hospital das Clinicas, UFPE. Being invited to participate and informed about its content, saying their participation by signing a Term of Consent. Data collection is in accordance with the Declaration of Helsinki, and will begin after the project was approved by the Ethics Committee for Research on Human beings of the Federal University Health Sciences Center of Pernambuco, in accordance with Resolution 466/2012 of the National Research Ethics Committee of the Ministry of Health, the body that regulates research involving human subjects. The study will be registered in the digital Clinical Trials platform after obtaining the registration number of the Ethics Committee. Initially there will be a pilot study with 20 women, then the results will be used to calculate the sample size using the G Power (version 3.1.9.2, Germany), considering a statistical power (β) of 80% with a significance level (α) of 5%.
Will be excluded those that have some other rheumatologic disease, cardio-respiratory or cardiovascular that prevents the realization of aerobic exercise protocol; low attendance during the implementation of the exercise program (over three consecutive absences); cognitive impairment or neurological disease that compromises the understanding and the exercises; Body mass index ≥ 30.0 (obesity, according to the World Society of Health); pregnant women and patients classified as level of active or very active physical activity by IPAQ (International Physical Activity Questionnaire).
3.1. Randomization
Initially, patients will undergo will a simple randomization through the site www.randomization.com, resulting in two groups:
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •30-55 years
- •Clinical diagnosis of fibromyalgia, according to the American College of Rheumatology criteria (2010)
- •Migraine presence, according to the criteria of the International Headache Society (ICHD-III beta version, 2013).
排除标准
- •Any other rheumatologic disease, cardio-respiratory or cardiovascular which prevents the realization of aerobic exercise protocol.
- •Low attendance during the implementation of aerobic exercise protocol (over three consecutive fouls).
- •Cognitive impairment or neurological disease that affects the understanding and the exercises.
- •Pregnants
- •Body mass index ≥ 30.0 (obesity, according to the World Health Company)
- •Patients classified with level of active or very active physical activity by IPAQ (International Physical Activity Questionnaire)
结局指标
主要结局
Pain intensity (headache)
时间窗: End of aerobic exerise protocol (in the end of 12 weeks of training)
At the end of the experimental protocol, it is expected that the intensity of migraine pain is reduced. Reviewed by MIDAS and headache diary.
次要结局
- Frequence of migraine attacks(End of aerobic exerise protocol (in the end of 12 weeks of training))
- Duration of attacks of migraine(End of aerobic exerise protocol (in the end of 12 weeks of training))
研究者
Manuella Moraes Monteiro Barbosa Barros
Physiotherapist
Universidade Federal de Pernambuco