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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01407861
Other study ID # Aerobic-Relax-Migraine
Secondary ID
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


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
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