The Effect of Aerobic Exercise Training for Migraine Prevention.

Headache Disorders, Primary Clinical Trial

Official title:

The Effect of Aerobic Exercise Training for Migraine Prevention.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972607
• Other study ID #: 081511
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: March 2016

Study information

• Verified date: December 2020
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Headache Disorders, Primary
• Migraine Disorders

Intervention

Other:
• Exercise Training
12 weeks of aerobic exercise training performed 3x/week at moderate intensity with sessions of 40 min.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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.
Primary	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	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