The Effect of Aerobic Exercise Training for Migraine Prevention.

Not Applicable

Completed

• Conditions: Headache Disorders, Primary

• Registration Number: NCT01972607
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-10-21
• Study First Submitted QC: 2013-10-24
• Study First Posted: 2013-10-30
• Primary Completion: 2015-03
• Study Completion: 2016-03
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-25
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Frequency of Migraine/month	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	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 São Paulo, SP, Brazil