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Completed

NCT Number: NCT01972607

The Effect of Aerobic Exercise Training for Migraine 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.

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Key information

Conditions

Headache Disorders, Primary Brain Diseases Central Nervous System Diseases Headache Disorders Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Sao Paulo

São Paulo, 04021-001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise training

Other

12 weeks of aerobic exercise training performed 3x/week at moderate intensity with sessions of 40 min.

Primary outcomes

  1. 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.

  2. 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

  1. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Oct 30, 2013
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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