Migraine
Conditions
Brief summary
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.
Interventions
OTHERRelaxation Training
Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.
Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Germany
Outcome results
None listed