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Aerobic Endurance Training vs. Relaxation Training in Patients With Migraine

NCT ID: NCT01407861

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Relaxation training

Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.

Group Type ACTIVE_COMPARATOR

Relaxation Training

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Aerobic endurance Training

Intervention Type OTHER

Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.

Interventions

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Relaxation Training

Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.

Intervention Type OTHER

Aerobic endurance Training

Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Hans-Christoph Diener

Prof. of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charly Gaul, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University of Duisburg-Essen

Locations

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Department of Neurology, University of Duisburg-Essen

Essen, , Germany

Site Status

Countries

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Germany

References

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Totzeck A, Unverzagt S, Bak M, Augst P, Diener HC, Gaul C. Aerobic endurance training versus relaxation training in patients with migraine (ARMIG): study protocol for a randomized controlled trial. Trials. 2012 Apr 27;13:46. doi: 10.1186/1745-6215-13-46.

Reference Type DERIVED
PMID: 22540391 (View on PubMed)

Other Identifiers

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Aerobic-Relax-Migraine

Identifier Type: -

Identifier Source: org_study_id