CClinicalTrials.gg
CompletedNCT01972607Updated Dec 29, 2020

The Effect of Aerobic Exercise Training for Migraine Prevention.

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

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Headache Disorders, Primary

Keywords

  • Migraine, aerobic exercise, prevention
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (actual)

Study arms

  • No intervention
    CONTROL

    This group will receive the same treatment of the experimental group after the test-retest measurements.

  • Experimental
    EXERCISE

    This group will receive the treatment with aerobic exercise training

    Other: Exercise Training

Interventions

  • OtherExercise Training

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

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What researchers measure

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.

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Study locations

1 site
  • Federal University of Sao Paulo
    São Paulo, SP 04021-001, Brazil
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References and documents

Publications

  • Oliveira AB, Ribeiro RT, Mello MT, Tufik S, Peres MFP. Anandamide Is Related to Clinical and Cardiorespiratory Benefits of Aerobic Exercise Training in Migraine Patients: A Randomized Controlled Clinical Trial. Cannabis Cannabinoid Res. 2019 Dec 9;4(4):275-284. doi: 10.1089/can.2018.0057. eCollection 2019. PubMed 31872062 ↗
  • Belitardo de Oliveira A, de Mello MT, Tufik S, Peres MFP. Weight loss and improved mood after aerobic exercise training are linked to lower plasma anandamide in healthy people. Physiol Behav. 2019 Mar 15;201:191-197. doi: 10.1016/j.physbeh.2018.12.018. Epub 2018 Dec 19. PubMed 30578894 ↗
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Registry details

Key details

Study ID
NCT01972607
Lead sponsor
Federal University of São Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Responsible party
Arão Belitardo de Oliveira (Prof. BS. Arão Belitardo de Oliveira, Federal University of São Paulo) — Principal investigator
First posted
Oct 30, 2013
Start date
Mar 2012
Primary completion
Mar 2015
Completion
Mar 2016
Last update
Dec 29, 2020

Study contacts

Mario FP Peres, MD, PhD
study chair · Federal University of São Paulo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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