Evaluation of an Aerobic Exercise Program in Migraine Management

Study Overview
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Brief Summary
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This trial assesses the impact of a supervised aerobic exercise program by a kinesiologist in patients with migraine. Patients can be assigned to one of two groups 1)The exercise group or 2)non-exercise group. This is a important area to study because there is currently limited information regarding exercise and its impact on migraine frequency and severity. In many cases, migraine patients are disabled by their headaches and sometimes will not have a significant response to medications. As a result, it is important to study other non-pharmacological interventions. In this study, the investigators hope to show the benefits of exercise by a reduction in number of headache days per month as well as by improvement in quality of life, disability,depression,anxiety,and aerobic fitness.This study will not interfere with the usual treatment patients receive at our headache clinic and patients can remain on medications deemed necessary.

Official Title
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Evaluation of an Aerobic Exercise Program in Migraine Management

Conditions
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Migraine

Intervention / Treatment
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* Other: Aerobic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must meet diagnostic criteria for migraine without aura, migraine with aura or chronic migraine. Patients must be 18-50 years of age. Individuals motivated to exercise and complete the study. - Exclusion Criteria: Patient has a headache on more than 25 days a month Patient is a medication over-user by International Headache Society (IHS) criteria Patient currently has a fitness program with regular aerobic exercise for 30 minutes three times a week or more. Known cardiovascular disease which contraindicates the exercise program Inability to complete the outcome measure questionnaires. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 58 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic Exercise<br>Fitness program for migraine patients in addition to usual headache care. | Other: Aerobic exercise<br>* Patients receiving exercise program in addition to usual headache care<br>|
| No Intervention: Control Group<br>Patients receiving usual headache care but no exercise program | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days with headache per month (based on headache diaries),comparing the change from baseline to month 3 and 6 post-randomization in the control versus the intervention group. Migraine Specific Quality of Life Questionnaire scores |  | At baseline,3, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Show Improvement in measures of quality of life,disability,depression,anxiety,and aerobic fitness | Headache Impact Test (HIT-6 )score, Migraine Disability Assessment scores, Patient Health Questionnaire(PHQ-9 )scores,Generalized Anxiety Disorder (GAD-7) scores, Average headache intensity, Body Mass Index, Aerobic fitness | Baseline, 3 ,6 months post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Fitness program