Aerobic Training Effect on the Improvement of Pain Perception in Patients With Fibromyalgia and Migraine
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|ClinicalTrials.gov Identifier: NCT02458326|
Recruitment Status : Unknown
Verified May 2015 by Manuella Moraes Monteiro Barbosa Barros, Universidade Federal de Pernambuco.
Recruitment status was: Recruiting
First Posted : June 1, 2015
Last Update Posted : June 1, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Migraine Fibromyalgia||Other: Aerobic training Other: Control Training||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Aerobic Training Effect on the Improvement of Pain Perception in Patients With Fibromyalgia and Migraine: a Randomized Clinical Trial|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||September 2015|
Experimental: Aerobic Training
The experimental group will follow the protocol: performing heating for 5 minutes at low speed on a treadmill; after heating, the speed is increased gradually until the patient reaches the proper heart rate for aerobic training obtained during cardiopulmonary exercise testing, maintaining the same for 20 minutes to perform the aerobic workout; completed, the velocity will be decreased to regain speed heating maintained for 5 minutes and finishing training. It is envisaged that in practice using the FC to ensure proper aerobic exercise for 20-60 minutes at a frequency of 3-5 times per week are effective in increasing the functional capacity of individuals with low fitness
Other: Aerobic training
Treadmill training with proper heart rate for aerobic workout to 20 minutes duration and frequency of three times a week for three months.
In the control group, these women will be guided to perform 10 minutes of heating on the treadmill with a low speed that does not cause patient effort (monitored by the Borg scale and FC close to the basement).
Other: Control Training
10 minutes of heating on the treadmill with a low speed that does not cause patient effort
- Pain intensity (headache) [ Time Frame: 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.
- Duration of attacks of migraine [ Time Frame: 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 duration of attacks of migraine is reduced (days, hours). Reviewed by MIDAS and headache diary.
- Frequence of migraine attacks [ Time Frame: End of aerobic exerise protocol (in the end of 12 weeks of training) ]t the end of the experimental protocol, it is expected that the frequence of attacks of migraine is reduced (per months). Reviewed by MIDAS and headache diary.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458326
|Contact: Manuella MB Barros, Master||55 81 email@example.com|
|Contact: Daniella A Oliveira, PhD||55 81 firstname.lastname@example.org|
|Principal Investigator:||Manuella MB Barros, Master||Universidade Federal de Pernambuco|