The Effect of Aerobic Exercise Training for Migraine Prevention.

NCT01972607 | Completed

• 1 other identifier: 081511
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache Disorders, Primary

Keywords

Migraine, aerobic exercise, prevention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

CONTROL

NO INTERVENTION

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

EXERCISE

EXPERIMENTAL

This group will receive the treatment with aerobic exercise training

Other: Exercise Training

Interventions

Exercise Training OTHER

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

EXERCISE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04021-001, Brazil

Location

Related Publications (2)

• 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.

  PMID: 31872062 DERIVED

• 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.

  PMID: 30578894 DERIVED

MeSH Terms

Conditions

Headache Disorders, Primary; Migraine Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mario FP Peres, MD, PhD

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. BS. Arão Belitardo de Oliveira

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: October 30, 2013
• Study Start: March 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2016
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

BR (1)