Aerobic Endurance Training vs. Relaxation Training in Patients With Migraine

Study Overview
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Brief Summary
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This is a single centre, open label, prospective, randomized study on the prophylactic effect of moderate aerobic endurance training versus relaxation training in patients with migraine.

Official Title
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Aerobic Endurance Training Versus Relaxation Training in Migraine Prophylaxis

Conditions
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Migraine

Intervention / Treatment
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* Other: Relaxation Training
* Other: Aerobic endurance Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient's signature on the informed consent document [each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form]. Patients have a clinical diagnosis of migraine with or without aura according to IHS criteria at least one year prior to enrollment. Patients have a clinical diagnosis of migraine with or without aura and in addition a clinical diagnosis of tension type headache according to IHS criteria, if patients are able to differentiate between the two headache diagnoses and if migraine is more frequent in these patients Patients that report at least three headache days per month Exclusion Criteria: Diseases or disabilities that disqualify to perform either aerobic endurance training or relaxation training Language difficulties that disable to fill out questionnaires Pregnancy Additional diagnosis of secondary headache according to the IHS criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Relaxation training<br>Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks. | Other: Relaxation Training<br>* Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.<br>|
| Active Comparator: Aerobic endurance training<br>Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks. | Other: Aerobic endurance Training<br>* Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of headache days in the last 4 weeks of the 12-week training compared to baseline (4 weeks before start of the training). |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of headache days 12 weeks after finishing the training (follow up). |  | 20 weeks | 
| Consumption of analgetic agents/triptans |  | 20 weeks | 
| Increase in aerobic capability |  | 12 weeks | 
| Impact on burden of disease |  | 20 weeks | 
| Psychological Impact of Training |  | 20 |