Aerobic Endurance Training vs. Relaxation Training in Patients With Migraine (ARMIG)

Universität Duisburg-Essen

Status: Completed

Conditions: Migraine

Treatments: Other: Relaxation Training; Other: Aerobic endurance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT01407861

Aerobic-Relax-Migraine

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Relaxation training

Active Comparator group

Description:

Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.

Treatment:

Other: Relaxation Training

Aerobic endurance training

Active Comparator group

Description:

Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.

Treatment:

Other: Aerobic endurance Training