The Effect of Exercise on Migraine Attacks in Chronic Migraine

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of different exercise types and combinations on migraine attacks in patients with chronic migraine.

Official Title
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The Effect of Exercise on Migraine Attack Frequency in Chronic Migraine

Conditions
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Migraine, Chronic Migraine

Intervention / Treatment
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* Behavioral: Combined exercise
* Behavioral: Aerobic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of chronic migraine confirmed by a specialist neurologist according to ICHD-3B No obstacle to exercise in the evaluation made with physical examination and ECG Diagnosed with migraine for at least 12 months Between the ages of 18-50 Exclusion Criteria: Exercising regularly in the last 6 months Presence of concomitant internal and neurological diseases Anti-psychotic drug use Drug, alcohol addiction Pregnancy, breastfeeding Patients who cannot reach the targeted exercise level

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined exercise group<br>Aerobic plus resistance exercise intervention | Behavioral: Combined exercise<br>* aerobic plus resistance exercise<br>|
| Experimental: Aerobic exercise group<br>Only aerobic exercise intervention | Behavioral: Aerobic exercise<br>* Only aerobic exercise<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of days with migraine (in migraine frequency) | Defined as the number of days with a migraine headache in a month | Baseline and Week 12 and Week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of headache | A categorical, four level rating scale will be used to rate each headache as absent, mild, moderate, or severe | Baseline and Week 12 and Week 20 | 
| Responder rate | The responder rate is calculated as a percent reduction from baseline in the number of migraine days or number of moderate or severe headache days in each treatment period | Week 12 and 20 | 
| Depression and anxiety | Hospital Anxiety and Depression Scale (HADS) will be used. Score could score between 0 and 21 for either anxiety or depression . Higher points are associated with worse anxiety or depression | Baseline and Week 12 and Week 20 | 
| Migraine specific quality of life | Migraine Disability Assessment (MIDAS) questionnaire will be used . There is no upper limit on scoring. More than 21 points show severe disability. Higher points mean more disability | Baseline and Week 12 and Week 20 | 
| Aerobic capacity measurement | Astrand submaximal bicycle ergometer test will be used to measure aerobic capacity. | Baseline and Week 12 and Week 20 | 
| Acute treatment utilization | Change the frequency of use of acute headache medications(which not effect of migraine frequency) during the trial | Baseline and Week 12 and Week 20 | 
| Change in physical activity level | The International Physical Activity Questionnaires (IPAQ) short form will be used. Scoring is not classical numerical type. For activity type and duration are important for scoring. Higher points means more physical activity | Baseline and Week 12 and Week 20 | 

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