title: Aerobic endurance training versus relaxation training in patients with migraine (ARMIG): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Migraine is one of the most frequent headache diseases and impairs patients' quality of life. Up to now, many randomized studies reported efficacy of prophylactic therapy with medications such as beta-blockers or anti-epileptic drugs. Non-medical treatment, like aerobic endurance training, is considered to be an encouraging alternative in migraine prophylaxis. However, there is still a lack of prospective, high-quality randomized trials. We therefore designed a randomized controlled trial to evaluate the efficacy of aerobic endurance training versus relaxation training in patients with migraine (ARMIG).
  
  
  METHODS
  This is a single-center, open-label, prospective, randomized trial. Sixty participants with migraine are randomly allocated to either endurance training or a relaxation group. After baseline headache diary documentation over at least 4 weeks, participants in the exercise group will start moderate aerobic endurance training under a sport therapist's supervision at least 3 times a week over a 12-week period. The second group will perform Jacobson's progressive muscle relaxation training guided by a trained relaxation therapist, also at least 3 times a week over a 12-week period. Both study arms will train in groups of up to 10 participants. More frequent individual training is possible. The follow-up period will be 12 weeks after the training period. The general state of health, possible state of anxiety or depression, impairments due to the headache disorder, pain-related disabilities, the headache-specific locus of control, and the motor fitness status are measured with standardized questionnaires.
  
  
  CONCLUSIONS
  The study design is adequate to generate meaningful results. The trial will be helpful in gaining important data on exercise training for non-medical migraine prophylaxis.
  
  
  BACKGROUND
  The trial is registered at ClinicalTrials.gov: NCT01407861.
authors.affiliation: Headache Center, Department of Neurology, University Hospital Essen, University Duisburg-Essen, Hufelandstraße 55, 45147 Essen, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Totzeck
authors.forename: Susanne
authors.initials: S
authors.lastname: Unverzagt
authors.forename: Maja
authors.initials: M
authors.lastname: Bak
authors.forename: Pierre
authors.initials: P
authors.lastname: Augst
authors.forename: Hans-Christoph
authors.initials: HC
authors.lastname: Diener
authors.forename: Charly
authors.initials: C
authors.lastname: Gaul
mesh_terms: D001007:Anxiety / Q000523:psychology; D003863:Depression / Q000523:psychology; D004185:Disability Evaluation; D015444:Exercise; D005081:Exercise Therapy / Q000379:methods*; D005500:Follow-Up Studies; D006801:Humans; D008499:Medical Records; D008881:Migraine Disorders / Q000523:psychology / Q000628:therapy*; D011446:Prospective Studies; D012064:Relaxation Therapy / Q000379:methods*; D012107:Research Design