Headache Disorders, Primary
Conditions
Keywords
Migraine, aerobic exercise, 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.
Interventions
OTHERExercise Training
12 weeks of aerobic exercise training performed 3x/week at moderate intensity with sessions of 40 min.
Sponsors
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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.
Design outcomes
Primary
| 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
| 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
| 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. |
Countries
Brazil
Outcome results
None listed