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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01407861
First Posted: August 2, 2011
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hans-Christoph Diener, Universität Duisburg-Essen
  Purpose
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.

Condition Intervention
Migraine Other: Relaxation Training Other: Aerobic endurance Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aerobic Endurance Training Versus Relaxation Training in Migraine Prophylaxis

Resource links provided by NLM:


Further study details as provided by Hans-Christoph Diener, Universität Duisburg-Essen:

Primary Outcome Measures:
  • Reduction of headache days in the last 4 weeks of the 12-week training compared to baseline (4 weeks before start of the training). [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • Number of headache days 12 weeks after finishing the training (follow up). [ Time Frame: 20 weeks ]
  • Consumption of analgetic agents/triptans [ Time Frame: 20 weeks ]
  • Increase in aerobic capability [ Time Frame: 12 weeks ]
  • Impact on burden of disease [ Time Frame: 20 weeks ]
  • Psychological Impact of Training [ Time Frame: 20 ]

Enrollment: 56
Study Start Date: July 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Relaxation training
Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.
Other: Relaxation Training
Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.
Active Comparator: Aerobic endurance training
Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.
Other: Aerobic endurance Training
Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407861


Locations
Germany
Department of Neurology, University of Duisburg-Essen
Essen, Germany, 45147
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
Principal Investigator: Charly Gaul, MD Department of Neurology, University of Duisburg-Essen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hans-Christoph Diener, Prof. of Neurology, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01407861     History of Changes
Other Study ID Numbers: Aerobic-Relax-Migraine
First Submitted: August 1, 2011
First Posted: August 2, 2011
Last Update Posted: December 3, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases