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Clinical Trials/NCT01972607
NCT01972607
Completed
Not Applicable

The Effect of Aerobic Exercise Training for Migraine Prevention.

Federal University of São Paulo1 site in 1 country60 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Headache Disorders, Primary
Sponsor
Federal University of São Paulo
Enrollment
60
Locations
1
Primary Endpoint
Frequency of Migraine/month
Status
Completed
Last Updated
5 years ago

Overview

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 Description

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
March 2016
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Arão Belitardo de Oliveira

Prof. BS. Arão Belitardo de Oliveira

Federal University of São Paulo

Eligibility Criteria

Inclusion Criteria

  • Sedentary (\> 6 month) healthy subjects and sedentary (\> 6 month)subjects with migraine without aura, migraine with aura and chronic migraine;

Exclusion Criteria

  • Physically active(\> 1 day/week);
  • Tobacco user;
  • Alcohol or abuse drug user;
  • Taking any prescribed medication or, in the case of medication for migraine prevention, if taking \< 6 months.
  • Having any cardiovascular, pulmonary, endocrine-metabolic, rheumatic or other neurologic disease or psychiatric disorder such as bipolar disorder and post-traumatic stress disorder.
  • Undergoing surgical procedure less than 3 months before entering the study.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Days with Migraine(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)

Study Sites (1)

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