The Effect of Aerobic Exercise Training for Migraine Prevention.

Study Overview
=================
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.

Official Title
-----------------
The Effect of Aerobic Exercise Training for Migraine Prevention.

Conditions
-----------------
Headache Disorders, Primary

Intervention / Treatment
-----------------
* Other: Exercise Training


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CONTROL<br>This group will receive the same treatment of the experimental group after the test-retest measurements. | |
| Experimental: EXERCISE<br>This group will receive the treatment with aerobic exercise training | Other: Exercise Training<br>* 12 weeks of aerobic exercise training performed 3x/week at moderate intensity with sessions of 40 min.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, aerobic exercise, prevention