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Completed

NCT Number: NCT01407861

Aerobic Endurance Training vs. Relaxation Training in Patients With Migraine

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, University of Duisburg-Essen

Essen, 45147, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relaxation training

Other

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

Aerobic endurance training

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of headache days 12 weeks after finishing the training (follow up).

    Time frame: 20 weeks

  2. Consumption of analgetic agents/triptans

    Time frame: 20 weeks

  3. Increase in aerobic capability

    Time frame: 12 weeks

  4. Impact on burden of disease

    Time frame: 20 weeks

  5. Psychological Impact of Training

    Time frame: 20

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

Aerobic Endurance Training Versus Relaxation Training in Migraine Prophylaxis

Acronym: ARMIG

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2011
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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