Clinical Trial: The Effect of Aerobic Exercise Training for Migraine Prevention.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effect of Aerobic Exercise Training for Migraine Prevention.
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Federal University of São Paulo
Current Primary Outcome:
- 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. ]
Original Primary Outcome: Frequency of Migraine/month [ Time Frame: Migraine frequency measured between the first and 4th 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. ]
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Days with Migraine [ Time Frame: Days with migraine measured between the first and 4th 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 ]
Information By: Federal University of São Paulo
Dates:
Date Received: October 21, 2013
Date Started: March 2012
Date Completion:
Last Updated: April 7, 2016
Last Verified: April 2016
