An interventional study of Exercise Training in Headache Disorders, Primary, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-29.
Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Prevention
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.
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Federal University of São Paulo is the lead sponsor of 439 studies on the registry; 23 are open to participants now.
Compared within Migraine Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Headache Disorders, Primary. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This group will receive the same treatment of the experimental group after the test-retest measurements.
This group will receive the treatment with aerobic exercise training
Other: Exercise Training
12 weeks of aerobic exercise training performed 3x/week at moderate intensity with sessions of 40 min.
Frequency of Migraine/month
Time frame: 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
Time frame: 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.
Days with Migraine
Time frame: 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
Maximal Oxygen Uptake
Time frame: Measurements of the maximal oxygen uptake has been performed at Week 1, which is set as "baseline" measurement, and at week 16, which is set as "post-intervention" measurement.
The record gives a start of Mar 2012, a primary completion of Mar 2015 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo →