Aerobic Endurance Training vs. Relaxation Training in Patients With Migraine

NCT01407861 | Completed

• 1 other identifier: Aerobic-Relax-Migraine
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine

Outcome Measures

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).

  16 weeks

Secondary Outcomes (5)

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

  20 weeks

• Consumption of analgetic agents/triptans

  20 weeks

• Increase in aerobic capability

  12 weeks

• Impact on burden of disease

  20 weeks

• Psychological Impact of Training

  20

Study Arms (2)

Relaxation training

ACTIVE COMPARATOR

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

Other: Relaxation Training

Aerobic endurance training

ACTIVE COMPARATOR

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

Other: Aerobic endurance Training

Interventions

Relaxation Training OTHER

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

Relaxation training

Aerobic endurance Training OTHER

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

Aerobic endurance training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

Department of Neurology, University of Duisburg-Essen

Essen, 45147, Germany

Location

Related Publications (1)

• 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.

  PMID: 22540391 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Charly Gaul, MD

  Department of Neurology, University of Duisburg-Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. of Neurology

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 2, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

DE (1)