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The Effect of Aerobic Exercise Training for Migraine Prevention.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01972607
First Posted: October 30, 2013
Last Update Posted: April 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Arão Belitardo de Oliveira, Federal University of São Paulo
  Purpose
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.

Condition Intervention
Headache Disorders, Primary Other: Exercise Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Aerobic Exercise Training for Migraine Prevention.

Resource links provided by NLM:


Further study details as provided by Arão Belitardo de Oliveira, Federal University of São Paulo:

Primary Outcome Measures:
  • Frequency of Migraine/month [ Time Frame: 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 [ Time Frame: 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:
  • Days with Migraine [ Time Frame: 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 Outcome Measures:
  • Maximal Oxygen Uptake [ Time Frame: 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. ]

Enrollment: 60
Study Start Date: March 2012
Study Completion Date: March 2016
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: CONTROL
This group will receive the same treatment of the experimental group after the test-retest measurements.
Experimental: EXERCISE
This group will receive the treatment with aerobic exercise training
Other: Exercise Training
12 weeks of aerobic exercise training performed 3x/week at moderate intensity with sessions of 40 min.

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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972607


Locations
Brazil
Federal University of Sao Paulo
São Paulo, SP, Brazil, 04021-001
Sponsors and Collaborators
Federal University of São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Study Chair: Mario FP Peres, MD, PhD Federal University of Sao Paulo
  More Information

Responsible Party: Arão Belitardo de Oliveira, Prof. BS. Arão Belitardo de Oliveira, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01972607     History of Changes
Other Study ID Numbers: 081511
First Submitted: October 21, 2013
First Posted: October 30, 2013
Last Update Posted: April 11, 2016
Last Verified: April 2016

Keywords provided by Arão Belitardo de Oliveira, Federal University of São Paulo:
Migraine, aerobic exercise, prevention

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders
Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms