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.

Study Overview

• Status: Completed
• Conditions: Headache Disorders, Primary
• Intervention / Treatment: Other: Exercise Training

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04021-001
      • Federal University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 12 weeks of aerobic exercise training performed 3x/week at moderate intensity with sessions of 40 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Maximal Oxygen Uptake	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.

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
• Investigators: Study Chair: Mario FP Peres, MD, PhD, Federal University of São Paulo

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: October 24, 2013
• First Posted (ESTIMATE): October 30, 2013

Study Record Updates

• Last Update Posted (ACTUAL): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 25, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Migraine, aerobic exercise, prevention
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Migraine Disorders; Headache; Headache Disorders; Headache Disorders, Primary
• Other Study ID Numbers: 081511