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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
Sponsor:
Information provided by (Responsible Party):
Manuella Moraes Monteiro Barbosa Barros, Universidade Federal de Pernambuco

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Control Training
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • 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).

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

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


Contacts
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Contact: Manuella MB Barros, Master 55 81 92562343 manu_mmbb@hotmail.com
Contact: Daniella A Oliveira, PhD 55 81 99929915 sabino_daniella@ig.com.br

Locations
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Brazil
Universidade Federal de Pernambuco Recruiting
Recife, Pernambuco, Brazil, 50740560
Contact: Manuella MB Barros, Master    55 81 92562343    manu_mmbb@hotmail.com   
Contact: Daniella A Oliveira, PhD    55 81 9992 9915    sabino_daniella@ig.com.br   
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
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Principal Investigator: Manuella MB Barros, Master Universidade Federal de Pernambuco
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Responsible Party: Manuella Moraes Monteiro Barbosa Barros, Physiotherapist, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02458326    
Other Study ID Numbers: 37052114.3.0000.5208
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015
Keywords provided by Manuella Moraes Monteiro Barbosa Barros, Universidade Federal de Pernambuco:
Migraine
Fibromyalgia
Aerobic exercise
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases