Back to resultsThe Effect of Aerobic Exercise Training for Migraine Prevention.
Primary Purpose
Headache Disorders, Primary
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise Training
Sponsored by
About this trial
This is an interventional prevention trial for Headache Disorders, Primary focused on measuring Migraine, aerobic exercise, prevention
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.
Sites / Locations
- Federal University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
CONTROL
EXERCISE
Arm Description
This group will receive the same treatment of the experimental group after the test-retest measurements.
This group will receive the treatment with aerobic exercise training
Outcomes
Primary Outcome Measures
Frequency of Migraine/month
Plasma levels of anandamide, cytokines and aminopeptidases
Secondary Outcome Measures
Days with Migraine
Full Information
NCT ID
NCT01972607
First Posted
October 21, 2013
Last Updated
December 25, 2020
Sponsor
Federal University of São Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
1. Study Identification
Unique Protocol Identification Number
NCT01972607
Brief Title
The Effect of Aerobic Exercise Training for Migraine Prevention.
Official Title
The Effect of Aerobic Exercise Training for Migraine Prevention.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache Disorders, Primary
Keywords
Migraine, aerobic exercise, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
This group will receive the same treatment of the experimental group after the test-retest measurements.
Arm Title
EXERCISE
Arm Type
Experimental
Arm Description
This group will receive the treatment with aerobic exercise training
Intervention Type
Other
Intervention Name(s)
Exercise Training
Intervention Description
12 weeks of aerobic exercise training performed 3x/week at moderate intensity with sessions of 40 min.
Primary Outcome Measure Information:
Title
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.
Title
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 Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario FP Peres, MD, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Sao Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
04021-001
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
31872062
Citation
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.
Results Reference
derived
PubMed Identifier
30578894
Citation
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.
Results Reference
derived
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The Effect of Aerobic Exercise Training for Migraine Prevention.
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