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The Effect of Aerobic Exercise Training for Migraine Prevention.

NCT ID: NCT01972607

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Headache Disorders, Primary

Keywords

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Migraine, aerobic exercise, prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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EXERCISE

This group will receive the treatment with aerobic exercise training

Group Type EXPERIMENTAL

Exercise Training

Intervention Type OTHER

12 weeks of aerobic exercise training performed 3x/week at moderate intensity with sessions of 40 min.

CONTROL

This group will receive the same treatment of the experimental group after the test-retest measurements.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise Training

12 weeks of aerobic exercise training performed 3x/week at moderate intensity with sessions of 40 min.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Arão Belitardo de Oliveira

Prof. BS. Arão Belitardo de Oliveira

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mario FP Peres, MD, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

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Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 31872062 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30578894 (View on PubMed)

Other Identifiers

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081511

Identifier Type: -

Identifier Source: org_study_id