Aerobic Endurance Training vs. Relaxation Training in Patients With Migraine

Migraine Clinical Trial

— ARMIG  

Official title:

Aerobic Endurance Training Versus Relaxation Training in Migraine Prophylaxis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407861
• Other study ID #: Aerobic-Relax-Migraine
• Status: Completed
• Phase: N/A
• First received: August 1, 2011
• Last updated: December 2, 2014
• Start date: July 2011
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• Relaxation Training
Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.
• Aerobic endurance Training
Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.

Locations

Country	Name	City	State
Germany	Department of Neurology, University of Duisburg-Essen	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of headache days in the last 4 weeks of the 12-week training compared to baseline (4 weeks before start of the training).		16 weeks	No
Secondary	Number of headache days 12 weeks after finishing the training (follow up).		20 weeks	No
Secondary	Consumption of analgetic agents/triptans		20 weeks	No
Secondary	Increase in aerobic capability		12 weeks	No
Secondary	Impact on burden of disease		20 weeks	No
Secondary	Psychological Impact of Training		20	No