Clinical trial NCT01972607: The Effect of Aerobic Exercise Training for Migraine Prevention.
Official title: The Effect of Aerobic Exercise Training for Migraine Prevention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache Disorders, Primary
Keywords: Migraine, aerobic exercise, prevention
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2013-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of Migraine/month
timeFrame: 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.
measure: Plasma levels of anandamide, cytokines and aminopeptidases
timeFrame: 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:
measure: Days with Migraine
timeFrame: 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:
measure: Maximal Oxygen Uptake
timeFrame: 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.
Locations:
city: São Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Mario FP Peres, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.