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

This study is currently recruiting participants.
Verified January 2013 by Universität Duisburg-Essen
Sponsor:
Information provided by (Responsible Party):
Hans-Christoph Diener, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01407861
First received: August 1, 2011
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  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: Aerobic endurance training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aerobic Endurance Training Versus Relaxation Training in Migraine Prophylaxis

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of headache days 12 weeks after finishing the training (follow up). [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Consumption of analgetic agents/triptans [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Increase in aerobic capability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Impact on burden of disease [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Psychological Impact of Training [ Time Frame: 20 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Primary Completion Date: December 2013 (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: Aerobic endurance training
Patients participate in a moderate aerobic endurance training program under expert guidance 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407861

Contacts
Contact: Charly Gaul, MD +49201436960 charly.gaul@gmx.de
Contact: Andreas Totzeck, MD +49201436960 andreas.totzeck@uk-essen.de

Locations
Germany
Department of Neurology, University of Duisburg-Essen Recruiting
Essen, Germany, 45147
Contact: Charly Gaul, MD     +49201436960     charly.gaul@gmx.de    
Contact: Andreas Totzeck, MD     +49201436960     andreas.totzeck@uk-essen.de    
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
Principal Investigator: Charly Gaul, MD Department of Neurology, University of Duisburg-Essen
  More Information

No publications provided by Universität Duisburg-Essen

Additional 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
Study First Received: August 1, 2011
Last Updated: January 25, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 23, 2013