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

December 2, 2014 updated by: Hans-Christoph Diener, Universität Duisburg-Essen

Aerobic Endurance Training Versus Relaxation Training in Migraine Prophylaxis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Essen, Germany, 45147
        • Department of Neurology, University of Duisburg-Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Relaxation training
Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.
Other: Relaxation Training
Patients participate in a relaxation training program under expert guidance at least 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of headache days 12 weeks after finishing the training (follow up).
Time Frame: 20 weeks
20 weeks
Consumption of analgetic agents/triptans
Time Frame: 20 weeks
20 weeks
Increase in aerobic capability
Time Frame: 12 weeks
12 weeks
Impact on burden of disease
Time Frame: 20 weeks
20 weeks
Psychological Impact of Training
Time Frame: 20
20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität Duisburg-Essen

Investigators

  • Principal Investigator: Charly Gaul, MD, Department of Neurology, University of Duisburg-Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

August 1, 2011

First Submitted That Met QC Criteria

August 1, 2011

First Posted (ESTIMATE)

August 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aerobic-Relax-Migraine

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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