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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014